A device for clinical trials of fire dragon jar and application thereof

Abstract

The application discloses a device for clinical test of Huolongguan and application thereof, and belongs to the field of Huolongguan devices. The device comprises an outer shell, an electric heating element arranged in the inner part of the outer shell, an insulating metal film with a thickness of 0.2mm-0.5mm arranged between the electric heating element and the skin contact side, and a layer of inert visual and olfactory simulation material filled in the cavity between the inner wall of the outer shell and the insulating metal film. The device realizes the consistency of appearance, weight and operation feeling with the real Huolongguan through the full-contour outer shell; provides controllable heat source through the electric heating element; realizes uniform heat distribution, blocks gas diffusion and realizes electrical safety isolation through the insulating metal film; simulates the visual and olfactory characteristics of the burning of moxa through the mixture of wood powder and edible spices, but does not contain the active ingredients of folium artemisiae argyi, and ensures the pharmacological inertness. The application realizes the double-blindness of the operator and the subject in the clinical test of Huolongguan for the first time, and is suitable for the preparation of false control instruments in the randomized controlled test.

Description

Technical Field

[0001] This invention belongs to the field of fire dragon cupping devices, and more specifically, relates to a device for clinical trials of fire dragon cupping and its application. Background Technology

[0002] Fire Dragon Cupping is a traditional Chinese medicine external therapy that combines sliding cupping, the local heat and negative pressure generated by moxibustion, manual massage along the meridians, and the synergistic effects of herbal aromatic components (such as mugwort, cinnamon twigs, and ginger). In clinical applications, Fire Dragon Cupping is commonly used to treat inflammatory and painful conditions such as acute mastitis, musculoskeletal pain, and arthritis. It works by dilating blood vessels with heat to improve local perfusion, mechanically loosening edematous tissue and retained milk, promoting tissue fluid drainage, and regulating the neuroimmune system.

[0003] In clinical trials of physical interventions such as acupuncture, cupping, and moxibustion, the design of a sham control group is a core methodological requirement for evaluating specific therapeutic effects. Currently known sham moxibustion / cupping devices or methods mainly include the following types:

[0004] (1) Heat-insulating sham moxibustion device: A heat-insulating layer (such as a plaster pad or ceramic spacer) is set between the moxa cone and the skin to allow the subject to feel warmth but limit the actual heat conduction depth. A representative existing technology is the sham moxibustion device reported in Complementary Therapies in Medicine (2006, Complementary Therapies in Medicine, 14(1):53-60), which sets a heat-insulating pad at the bottom of the moxa cone.

[0005] (2) Non-combustible electrothermal sham moxibustion device: This device uses resistance wire or heating element as a heat source to replace the burning of moxa wool, simulating only the warmth of moxibustion without involving combustion products. A representative existing technology is the sham moxibustion device used in the clinical trial of moxibustion for knee osteoarthritis in Arthritis Research & Therapy (2014, Arthritis Research & Therapy, 16: R133).

[0006] (3) Non-acupoint / shallow needling sham acupuncture: Acupuncture is performed at non-treatment acupoints or at very shallow depths as a control in clinical trials of acupuncture.

[0007] (4) Fake cupping device: using a cupping cup with a small air pump to generate negative pressure but no heat effect, or placing the cup on the skin surface without applying negative pressure.

[0008] However, the above-mentioned existing technologies have the following fundamental shortcomings.

[0009] The shortcomings of existing technologies:

[0010] (1) Mismatch in appearance and weight: Existing fake moxibustion / cupping devices are usually independently designed electric heating devices. Their shape, size and weight are significantly different from real fire dragon cups (including cups with burning moxa cones). Operators can easily distinguish between real and fake devices by holding them and looking at their appearance, making it impossible to achieve double-blind testing for operators and subjects.

[0011] (2) Incomplete sensory simulation: Existing electric heating dummy devices only provide a uniform warmth and lack the unique smoke appearance, the visual cue of leaping flames, and the complex aroma of burning moxa and herbs that are characteristic of real fire cupping. Subjects (especially those with previous fire cupping therapy experience) can easily identify the dummy devices through multiple sensory dimensions, leading to the failure of the blinding method.

[0012] (3) Odor dimension gap: Existing dummy devices completely fail to consider "odor," a core sensory dimension in the experience of cupping therapy. During cupping therapy, the burning of moxa and the release of aromatic volatiles from heated herbs are key clues for subjects to perceive the "realism" of the treatment. Existing devices have a fundamental simulation gap in this dimension.

[0013] (4) Ineffective isolation of herbal pharmacologically active ingredients: Existing dummy devices only consider isolating heat or simulating the feeling of warmth, but fail to effectively isolate the potential pharmacological effects of moxa burning products (such as volatile terpenoids: eucalyptol, camphor, thujone, and about 200 other compounds) and herbal active ingredients (such as cinnamaldehyde in cinnamon twigs and gingerol compounds in ginger) while maintaining the appearance and odor simulation. This means that existing dummy devices cannot distinguish between "specific herbal-moxibustion pharmacological effects" and "non-specific thermal effects, tactile effects, ritual / placebo effects".

[0014] (5) Insufficient temperature control accuracy and safety: Some existing dummy devices lack a precise closed-loop control system for skin surface temperature and an automatic overheat protection mechanism. In special populations such as breastfeeding patients with mastitis, whose tolerance to heat damage may be reduced, there is a risk of low-temperature burns. Low-temperature burns refer to deep tissue damage caused by prolonged skin contact with a heat source at 44-50°C, and are particularly dangerous in patients with impaired sensation or distracted attention.

[0015] (6) Lack of standardized operation and quality control system: Existing dummy devices usually do not come with standardized operating scripts (including unified passwords, techniques and communication language), temperature monitoring schemes (frequency and recording specifications of infrared temperature measurement) and fidelity checklists, resulting in insufficient consistency of operation between different operators and between different research centers, making it difficult to meet the methodological requirements of multicenter randomized controlled clinical trials. Summary of the Invention

[0016] The main objective of this invention is to provide a device and its application for clinical trials of fire dragon cupping, thereby filling the technological gap in existing clinical trials of fire dragon cupping by providing a false control device that can effectively simulate the full-dimensional sensory experience of real fire dragon cupping in terms of "appearance, weight, temperature, smell, and handling feel," while reliably isolating the burning products of moxa wool and the pharmacological effects of herbal active ingredients.

[0017] According to a first aspect of the present invention, an apparatus for clinical trials of fire dragon cupping is provided, comprising:

[0018] outer shell;

[0019] An electric heating element, wherein the electric heating element is disposed inside the housing;

[0020] An insulating metal film is disposed between the electric heating element and the skin contact side, and the thickness of the insulating metal film is 0.2mm-0.5mm;

[0021] An inert visual and olfactory simulation material layer is filled in the cavity between the inner wall of the outer shell and the insulating metal film.

[0022] According to the first aspect of the present invention, the device for clinical trials of fire dragon cupping is made of stainless steel, aluminum alloy or titanium alloy; the insulating metal membrane is used to limit deep heat penetration, block the diffusion of simulated gas from burning moxa wool to the skin side, and provide electrical safety isolation.

[0023] According to the first aspect of the present invention, the device for clinical trials of Huolongguan (a traditional Chinese medicine device) includes an inert visual and olfactory simulation material layer comprising an inert visual simulation material and an inert olfactory simulation material.

[0024] The inert visual simulation material is wood powder, which is selected from sandalwood powder or pine powder. The particle size of the wood powder is less than 180μm, and the amount of wood powder used is 12g-20g.

[0025] The inert olfactory simulation material is an edible spice mixture, which is selected from one or more of cinnamon powder, ginger powder and dried tangerine peel powder. The amount of cinnamon powder used is 1g-3g, the amount of ginger powder used is 0.5g-2g, and the amount of dried tangerine peel powder used is 0.5g-2g.

[0026] The device for clinical trials of fire dragon cupping according to the first aspect of the present invention further includes a temperature sensor and a temperature control module. The temperature sensor is disposed on the inner side of the insulating metal film, and the temperature control module is used to maintain the skin surface temperature at 40°C-42°C and set the overheat automatic power-off threshold to 44°C.

[0027] According to the first aspect of the present invention, the device for clinical trials of fire dragon cupping is provided, wherein the electric heating element is a positive temperature coefficient ceramic heating element, the rated power of the electric heating element is 12W-18W, and the Curie temperature of the positive temperature coefficient ceramic heating element is set to 80℃-100℃.

[0028] According to the first aspect of the present invention, in the device for clinical trials of the "Fire Dragon Cup", the insulating metal film is fixed to the inner edge of the cup mouth of the outer shell by a silicone sealing ring, the silicone sealing ring being made of a high-temperature resistant medical-grade material, and the silicone sealing ring having a temperature resistance of not less than 200°C.

[0029] The device for clinical trials of Huolongguan according to the first aspect of the present invention further includes a power supply module, wherein the power supply module is a built-in rechargeable lithium-ion battery and its continuous power supply time is not less than 45 minutes.

[0030] According to a second aspect of the present invention, a system for clinical trials of Huolongguan (a traditional Chinese medicine treatment) is provided, comprising the above-described apparatus, an operator training manual, a standardized operating script, and a fidelity checklist for each treatment.

[0031] According to a third aspect of the present invention, the above-described apparatus is provided for use in the preparation of a sham control device for randomized controlled clinical trials.

[0032] According to the application described in the third aspect of the present invention, the randomized controlled clinical trial is a clinical trial for traditional moxibustion therapy, which includes any one or more of the following: medicated moxibustion, ginger-separated moxibustion, garlic-separated moxibustion, thunder-fire moxibustion, or Taiyi acupuncture.

[0033] One of the above-described technical solutions of the present invention has at least one of the following advantages or beneficial effects:

[0034] (1) Achieving true double-blindness in the clinical trial of Fire Dragon Cupping for the first time: Through full-dimensional matching of appearance, size, weight, surface temperature and handling feel, even experienced Fire Dragon Cupping practitioners cannot distinguish between genuine and counterfeit devices by sensory perception. This is a major methodological breakthrough in the field of evidence-based research on Fire Dragon Cupping, enabling placebo / ritual / expectation effects to be included in the analysis framework as measurable clinical variables, rather than as uncontrollable confounding factors.

[0035] (2) The dual mechanism of “full sensory simulation and pharmacological isolation”: It simultaneously solves the two technical requirements of “sensory authenticity” and “pharmacological purity” that are usually contradictory in the design of traditional physical therapy pseudo-controls.

[0036] (3) Filling the technological gap in olfactory simulation: This invention introduces for the first time a visual and olfactory composite simulation scheme of "inert wood powder and food-grade spices" in a fake fire dragon cup or fake moxibustion device. The key to this scheme is that: (a) the heat-induced volatiles of the selected wood (sandalwood / pine) and spices (cinnamon / ginger / dried tangerine peel) are mainly terpenes and aromatic aldehydes, which are indistinguishable from the smell of burning mugwort, cinnamon twigs and ginger in subjective human olfactory evaluation; (b) however, they can be clearly distinguished from the volatiles of mugwort leaves at the chemical fingerprint level (does not contain eucalyptol, camphor, or thujone), providing verifiable chemical evidence for the "pharmacological inertness" of the fake device.

[0037] (4) Significantly improves operational safety: The insulating metal film, PTC Curie temperature self-limiting protection, 44℃ power-off threshold of the temperature controller, and manual monitoring of infrared temperature measurement every 5 minutes constitute a quadruple temperature protection system. This design is particularly suitable for people with extremely high safety requirements, such as breastfeeding patients with mastitis, reducing the risk of low-temperature burns to near zero.

[0038] (5) Complete standardization and quality control system: This invention not only provides hardware devices, but also complete operator training manuals, standardized operating scripts, and fidelity checklists for each treatment. This system design stems from the actual needs of multi-center clinical trials, ensuring operational consistency and data comparability among different operators and research centers.

[0039] (6) Natural compatibility with dual-dummy design: The dummy fire dragon cup device of the present invention is naturally suitable for use with oral placebo / active drug capsules, supporting multiple combinations such as "dummy FC and oral placebo" and "dummy FC and active antibiotic", and has been successfully implemented in a registered clinical trial with a three-arm dual-dummy design.

[0040] (7) Extendable design framework: The design concept of this invention (full-shape shell, electric heating, insulating film isolation and inert simulation material) is not only applicable to the Fire Dragon Cup, but can also be extended to the design of false control devices for other traditional physical therapies involving the synergistic effect of heat and herbal combustion (such as moxibustion with medicine, ginger moxibustion, garlic moxibustion, thunder and fire moxibustion, Taiyi Divine Needle, etc.), which has a wide range of potential applications. Attached Figure Description

[0041] The present invention will be further described below with reference to the accompanying drawings and embodiments;

[0042] Figure 1 This is a cross-sectional view of an apparatus used in clinical trials of the Fire Dragon Cupping device according to some embodiments of the present invention;

[0043] Explanation of reference numerals in the attached figures:

[0044] 1-Outer shell; 2-Electric heating element; 3-Aluminum alloy heat-conducting bracket; 4-Insulating metal film; 5-Silicone sealing ring; 6-Inert visual and olfactory simulation material layer; 7-K-type thermocouple; 8-Power cord; 9-Power supply module; 10-Power switch. Detailed Implementation

[0045] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0046] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0047] In the description of this invention, "several" means one or more, "more than" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0048] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" and "second" may explicitly or implicitly include one or more features.

[0049] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the term "connection" should be interpreted broadly. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection or a connection that allows communication between the two components; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components, an indirect connection, or an interaction between two components.

[0050] The following disclosure provides many different implementations or examples for different ways of implementing the present invention.

[0051] Reference Figure 1As shown, a device for clinical trials of fire dragon cupping is provided, referred to as a "fake fire dragon cupping device," comprising: an outer shell 1 (which is identical in shape, size, and weight to a real fire dragon cupping device); an electric heating element 2 located within the outer shell 1 (providing heat to simulate the burning of moxa); an insulating metal film 4 (0.2-0.5 mm thick, preferably 0.3 mm) disposed between the electric heating element 2 and the skin contact side; and an inert visual and olfactory simulation material layer 6 filled between the inner wall of the outer shell 1 and the insulating metal film 4.

[0052] The insulating metal film 4 is made of stainless steel (preferably 304 food-grade stainless steel), aluminum alloy, or titanium alloy. The insulating metal film 4 has a triple function: limiting deep heat penetration, blocking the diffusion of simulated gas from burning moxa wool to the skin, and providing electrical safety isolation.

[0053] The inert visual and olfactory simulation material layer 6 comprises a mixture of wood powder and food-grade spices. The wood powder is selected from sandalwood powder or pine powder (particle size less than 180μm, amount 12-20g), and the spice mixture is selected from one or more of cinnamon powder (1-3g), ginger powder (0.5-2g), and dried tangerine peel powder (0.5-2g). The simulation material layer 6 explicitly does not contain mugwort or its extracts, essential oils, or any products containing mugwort active ingredients.

[0054] The device of the present invention also includes a temperature sensor (attached to the inside of the insulating metal film 4) and a temperature control module. The temperature control module maintains the skin surface temperature at 40-42°C and sets the overheat automatic power-off threshold to 44°C.

[0055] The electric heating element 2 is a positive temperature coefficient (PTC) ceramic heating element with a rated power of 12-18W. The Curie temperature of the PTC ceramic heating element is set to 80-100℃, providing internal overheat self-limiting protection.

[0056] The insulating metal film 4 is fixed to the inner edge of the cup mouth of the outer shell 1 by a high-temperature resistant medical-grade silicone sealing ring 5 (withstanding temperature ≥200℃).

[0057] The device of the present invention also includes a power supply module 9 (with a built-in rechargeable lithium-ion battery) that provides continuous power for a duration of 45 minutes or more.

[0058] In a second aspect embodiment, a system for clinical trials of fire dragon cupping is provided, comprising the aforementioned dummy fire dragon cupping device, as well as an operator training manual, standardized operating scripts, and a fidelity checklist for each treatment.

[0059] The above-mentioned device or system is used in the following clinical trial designs:

[0060] (a) A double-blind randomized controlled trial (RCT) in which neither the operator nor the subject can distinguish between a genuine and a counterfeit device by sensory means;

[0061] (b) A double-dummy trial design, wherein the dummy fire dragon cup device is used in conjunction with an oral placebo or active drug capsule;

[0062] (c) A three-arm or multi-arm clinical trial design, including at least two combinations of a real fire dragon cupping group, a fake fire dragon cupping group, and an active drug control group.

[0063] The design concept and structural framework of the above-mentioned device can be applied to the design of pseudo-control devices for the following traditional physical therapy methods: moxibustion with medicine, ginger-separated moxibustion, garlic-separated moxibustion, thunder-fire moxibustion, and Taiyi Divine Needle.

[0064] Example 1

[0065] The fake dragon pot device consists of the following components (see appendix) Figure 1 (Schematic diagram of the cross-sectional structure of the fake fire dragon pot device)

[0066] The first component – ​​outer shell 1: Made of the exact same material and manufactured using the same process as the real fire dragon cupping jar (preferably heat-resistant ceramic, such as stoneware or bone china; borosilicate heat-resistant glass may also be used). The outer shell 1 has the following dimensions: inner diameter of the cup opening 50-60mm (preferably 55mm), cup height 80-100mm (preferably 90mm), and wall thickness 3-5mm (preferably 4mm). The appearance of the outer shell 1 (including but not limited to glaze color, texture, handle shape and size, and cup rim shape) is completely identical to that of the real fire dragon cupping jar. The total weight of the entire device (including all internal components and the battery) is controlled at 180g ± 5g, consistent with the weight of a medium-sized real fire dragon cupping jar from the same batch containing 18mm × 27mm moxa sticks.

[0067] The second component – ​​ceramic heating element 2 – is located inside the outer casing 1, near the rim of the cup. It employs a positive temperature coefficient (PTC) ceramic heating element with the following specifications: rated voltage 24VDC, rated power 12-18W (preferably 15W), and Curie temperature set at 80-100℃ (ensuring the PTC element automatically limits current after reaching the Curie temperature, providing inherent overheat protection). The PTC heating element is embedded in an aluminum alloy heat-conducting bracket 3, with a 1-2mm air gap maintained between the heat-conducting bracket 3 and the insulating metal film 4, forming a step-by-step heat transfer path: heating element 2, heat-conducting bracket 3, air gap, insulating metal film 4, and skin.

[0068] The third component – ​​the insulating metal film 4 – is disposed between the heating element 2 and the skin contact side. It is a circular metal film with a thickness of 0.2-0.5 mm (preferably 0.3 mm) and a diameter slightly larger than the inner diameter of the cup opening (55-62 mm, preferably 58 mm). The metal film is preferably made of 304 stainless steel (food grade), but aluminum alloy (such as 6061 alloy) or titanium alloy can also be used. This insulating metal film 4 has three functions:

[0069] (a) Heat penetration restriction function: The high thermal conductivity of the metal film 4 (approximately 16 W / m·K for 304 stainless steel) allows the heat generated by the heating element 2 to be rapidly and evenly diffused within the film plane, forming a uniform surface heat source and avoiding point-like high temperatures; at the same time, the air gap between the metal film 4 and the skin and the heat capacity of the metal film 4 itself work together to control the heat transferred to the deep layers of the skin at a level that produces a warm and comfortable feeling but does not cause deep tissue heating.

[0070] (b) Material isolation function: The metal membrane 4 acts as an impermeable barrier, physically preventing any particulate matter or macromolecules in the simulated gas of burning moxa (trace components volatilized by wood powder and spices when heated) on the heating module side from directly diffusing to the skin side, ensuring the undetectability of substances in the gas exiting the fake device and characteristic pharmacological markers of real burning moxa (eucalyptol, camphor, thujone, caryophyllene, etc.).

[0071] (c) Electrical safety isolation function: The metal film 4 is grounded or serves as part of the insulation protection layer to ensure that the circuit of the heating element 2 is completely isolated from the human body (meeting the relevant creepage distance requirements of the IEC60601 medical electrical equipment safety standard).

[0072] The insulating metal film 4 is fixed to the inner edge of the cup mouth of the outer shell 1 by a high-temperature resistant medical-grade silicone sealing ring 5 (withstanding a temperature greater than or equal to 200℃). The sealing ring 5 also serves to reduce shock and prevent the metal film 6 from falling off during operation.

[0073] The fourth component – ​​inert visual and olfactory simulation material layer 6: located within the cavity (approximately 50-80 mL) between the inner wall of the outer shell 1 and the insulating metal film 4. This material layer 6 is composed of a mixture of the following two inert materials:

[0074] (a) Inert visual simulation material: Sandalwood powder (ball-milled, passed through an 80-mesh sieve, particle size less than 180μm) or pine powder (of the same fineness) is used in an amount of 12-20g (preferably 15g), loosely filling the cavity. When heated to 40-50℃, the wood powder naturally emits a woody fragrance and appears as a fine powder, simulating the appearance of ash produced after burning moxa in a real fire dragon pot. Key characteristics: The wood powder used does not contain moxa leaves, and its volatile substances upon heating are mainly terpenes (α-pinene, β-pinene, etc.), which can be clearly distinguished from the chemical fingerprints of the volatile substances emitted by burning moxa (mainly eucalyptol, thujone, and camphor).

[0075] (b) Inert olfactory simulation material: A mixture of food-grade spices was selected, with the following formula: 1-3g (preferably 2g) of cinnamon powder (passed through a 60-mesh sieve), 0.5-2g (preferably 1g) of ginger powder (passed through a 60-mesh sieve), and 0.5-2g (preferably 1g) of dried tangerine peel powder (passed through a 60-mesh sieve). After the above three food-grade powders were mixed evenly, they were loosely mixed with wood powder (without compaction) and filled into the cavity. When heated to 40-50℃, the volatile components in the spices (cinnamaldehyde, gingerol decomposition products, limonene, etc.) were slowly released, and the resulting complex aromatic scent was indistinguishable from the scent of burning moxa, cinnamon twigs, and ginger in human subjective olfactory evaluation (verified by the triangular olfactory test, P > 0.05). Key limitations: This fragrance mixture explicitly does not contain Artemisia argyi or its extracts, essential oils or any products containing Artemisia argyi active ingredients; its heated volatiles, as analyzed by GC-MS, do not contain characteristic markers of Artemisia argyi burning such as eucalyptol, camphor, and thujone (detection limit less than 1 ppm).

[0076] The fifth component - Temperature Monitoring and Safety Protection Module: includes the following sub-components:

[0077] (a) Temperature sensor: A K-type thermocouple probe 7 (accuracy ±0.5℃) is attached to the inside (non-skin contact side) of the insulating metal film 4. The thermocouple probe 7 is input to a digital display temperature controller (such as OMRONE5CC or equivalent) through an amplification circuit to display the temperature of the metal film in real time.

[0078] (b) Infrared temperature measurement verification: Every 5 minutes, the operator uses a calibrated infrared thermometer (such as FLIRTG165 or equivalent, with an accuracy of ±1℃) to perform non-contact temperature measurement on the skin surface along the sliding path of the device and records it in the checklist.

[0079] (c) Automatic overheat protection: The thermostat is set to a power-off threshold of 44°C (i.e., the power supply to the PTC heating element 2 is automatically cut off when the temperature of the insulating metal film 4 exceeds 44°C). At the same time, the Curie temperature effect of the PTC element 2 itself provides a second layer of passive protection. In addition, the device is equipped with a manual emergency stop switch 10 (located on the outer side of the casing 1, which allows the operator to cut off the power with one button).

[0080] The sixth component – ​​power supply module 9 – is powered by a built-in rechargeable lithium-ion battery, consisting of two 18650 cells (3.7V, 2600mAh) connected in series (total voltage 7.4V, capacity 2600mAh), which power the PTC heating element 2 via a DC-DC boost module (boosted to 24V). A full charge provides a continuous working time of 45 minutes or more (meeting the standard 35-minute treatment and preheating time). The charging interface is Micro-USB or Type-C, and it is equipped with a charging status LED indicator.

[0081] Example 2

[0082] The fake fire dragon can device is equipped with the following standardized operating system:

[0083] (a) Operator Training Manual: The content includes the device assembly and start-up procedures, temperature preheating standards (operation can only begin after preheating to 40°C of the metal film), standardized techniques for applying lubricating medium (massage cream or 1-2mL of mugwort essential oil) to the body surface, standardized descriptions of the sliding route (front chest: along the mammary duct from ST18 Rugen acupoint towards the nipple; back: along the bladder meridian BL13 Feishu to BL18 Geshu, then to BL19 Ganshu, then to BL21 Weishu, and finally to BL22 Sanjiaoshu), sliding speed and force (approximately 2-3cm / second, light pressure), etc.

[0084] (b) Operating script: Use standardized commands and language when communicating with the subjects (e.g., "Please tell me whether the temperature you feel right now is comfortable, cool, or hot?").

[0085] (c) Checklist for each treatment: record device number, operation time (20 minutes ± 1 minute for the front chest, 15 minutes ± 1 minute for the back), skin surface temperature (measured and recorded every 5 minutes), skin reaction (0-3 grade flushing score), subject's subjective thermal comfort score (0-10 VAS), any adverse events or operational deviations.

[0086] Key differences from genuine fire dragon cupping jars and verification methods

[0087]

[0088] The present invention has the following significant advantages:

[0089] (1) Achieving true double-blindness in the clinical trial of Fire Dragon Cupping for the first time: Through full-dimensional matching of appearance, size, weight (tolerance ±5g), surface temperature and handling feel, even experienced Fire Dragon Cupping practitioners cannot distinguish between genuine and counterfeit devices by sensory perception. This is a major methodological breakthrough in the field of evidence-based research on Fire Dragon Cupping, enabling placebo / ritual / expectation effects to be included in the analytical framework as measurable clinical variables, rather than as uncontrollable confounding factors.

[0090] (2) Pioneering a dual mechanism of "full sensory simulation + pharmacological isolation": The core innovation of this invention lies in simultaneously solving the two technical requirements of "sensory realism" and "pharmacological purity" that are usually contradictory in the design of pseudo-controls in traditional physical therapy. The 0.3mm insulating metal film achieves: (a) uniform heat distribution (eliminating hot spots); (b) physical blocking of the diffusion of simulated gas from burning moxa wool to the skin side; (c) electrical safety isolation—these three functions are integrated into a single film, with a simple structure and powerful functions.

[0091] (3) Filling the technological gap in olfactory simulation: This invention introduces a visual / olfactory composite simulation scheme of "inert wood powder + edible spices" for the first time in the fake fire dragon cup / fake moxibustion device. The key innovation of this scheme is that: (a) the heat-induced volatiles of the selected wood (sandalwood / pine) and spices (cinnamon / ginger / dried tangerine peel) are mainly terpenes and aromatic aldehydes, which are indistinguishable from the smell of burning moxa wool + cinnamon twig + ginger in the subjective evaluation of human olfaction; (b) however, they can be clearly distinguished from the volatiles of mugwort leaves at the chemical fingerprint level (does not contain eucalyptol, camphor, thujone), providing verifiable chemical evidence for the "pharmacological inertness" of the fake device.

[0092] (4) Significantly improves operational safety: The 0.3mm insulating metal film, PTC Curie temperature self-limiting protection, 44℃ power-off threshold of the temperature controller, and manual monitoring by infrared temperature measurement every 5 minutes constitute a quadruple temperature protection system. This design is particularly suitable for people with extremely high safety requirements, such as breastfeeding patients with mastitis, reducing the risk of low-temperature burns to near zero.

[0093] (5) Complete standardization and quality control system: This invention not only provides hardware devices, but also complete operator training manuals, standardized operating scripts, and fidelity checklists for each treatment. This system design stems from the actual needs of multi-center clinical trials, ensuring operational consistency and data comparability among different operators and research centers.

[0094] (6) Natural compatibility with dual-dummy design: The dummy fire dragon cup device of the present invention is naturally suitable for use with oral placebo / active drug capsules, supporting multiple combinations such as "dummy FC and oral placebo" and "dummy FC and active antibiotic", and has been successfully implemented in a registered clinical trial with a three-arm dual-dummy design.

[0095] (7) Extendable design framework: The design concept of this invention (full-shape shell, electric heating, insulating film isolation and inert simulation material) is not only applicable to the Fire Dragon Cup, but can also be extended to the design of false control devices for other traditional physical therapies involving the synergistic effect of heat and herbal combustion (such as moxibustion with medicine, ginger moxibustion, garlic moxibustion, thunder and fire moxibustion, Taiyi Divine Needle, etc.), which has a wide range of potential applications.

[0096] Example 3

[0097] A dummy cupping device for a double-blind randomized controlled trial of acute lactational mastitis.

[0098] I. Equipment Manufacturing

[0099] Step 1: Outer Shell Manufacturing. Take a stoneware cup blank that is exactly the same as the real dragon-shaped jar (inner diameter of the cup mouth 55mm, height of the cup body 90mm, wall thickness 4mm), and fire it using the same glazing process (matte beige glaze). Leave an 8mm diameter hole at the bottom of the cup for the power cord.

[0100] Step 2: Heating Module Assembly. The PTC ceramic heating element (specifications: 24VDC, 15W, Curie temperature 90℃, dimensions 25mm×15mm×5mm, manufactured by an electronics company in Shenzhen) is embedded into an aluminum alloy thermally conductive bracket (bracket diameter 50mm, thickness 3mm, with a central slot to accommodate the PTC element). Thermal grease is applied to both sides of the PTC element before it is pressed into the bracket. The thermally conductive bracket is then fixed to a ring-shaped support platform inside the outer casing, 15mm from the cup rim, using three M2 stainless steel screws.

[0101] Step 3: Install the insulating metal film. Take a circular 304 stainless steel sheet (58mm in diameter, 0.3mm thick, with electrolytically polished surface) and embed its edge into the inner groove of a food-grade silicone sealing ring (60mm outer diameter, 54mm inner diameter, 3mm cross-sectional diameter, and temperature resistance up to 220℃). Press the sealing ring and the metal film into the annular groove on the inner edge of the cup rim, ensuring that the plane of the metal film is 5mm from the edge of the cup rim (i.e., leaving a 5mm air gap between the metal film and the skin).

[0102] Step 4: Simulated material filling. In the cavity (approximately 65 mL) between the outer shell and the insulating metal membrane, fill in the following in sequence: 15 g of sandalwood powder (pre-sterilized by drying at 105°C for 2 hours), 4 g of a pre-mixed spice mixture (2 g of cinnamon powder, 1 g of ginger powder, and 1 g of dried tangerine peel powder, all food grade, purchased from a Chinese herbal medicine company). Gently shake the powder by hand to distribute it loosely (without compacting it). The filling amount is approximately 50% of the cavity volume.

[0103] Step 5: Temperature Control and Power Supply Module Installation. Attach a type K thermocouple (OMEGA5TC-TT-K-36-36, 0.13mm wire diameter) to the center of the inner side of the insulating metal film. Lead the thermocouple through a hole at the bottom of the cup to the external digital temperature controller. Install an 18650 lithium battery compartment (containing two Samsung INR18650-35E cells connected in series, with overcharge / over-discharge / short circuit protection) on the outer side of the bottom of the cup. Connect the PTC heating element via a DC-DC boost module (XL6009, boosting to 24V). Set the temperature controller (XH-W3001 digital temperature controller) to: heating start temperature 40℃, power-off temperature 44℃. Install a small rocker-shaped power switch and an LED indicator light on the side of the outer casing.

[0104] Step 6: Overall Machine Inspection. After assembly, the following tests are performed sequentially: (a) The PTC heating element heats up to the working temperature within 30-60 seconds after power-on; (b) The temperature controller automatically cuts off the power when the temperature of the insulating metal film reaches 44±0.5℃; (c) The overall weight is 179.5g (compared to the actual weight of the same batch of fire dragon cupping jars containing 18mm×27mm moxa sticks, which is 182.3g, the difference is -2.8g, which is less than ±5g); (d) The outer shell passes the pressure resistance test (simulating the sliding pressure applied during operation, 5-10N), with no loosening or abnormal noise.

[0105] II. Verification data from the dummy device

[0106] Verification 1: Operator-blinded test. Twelve TCM practitioners with ≥2 years of clinical experience in fire dragon cupping were recruited. Each practitioner performed a standard fire dragon cupping operation once on a coded genuine device and once on a coded fake device (12 operations on each device, for a total of 24 operations). Immediately after the operation, the practitioner judged whether the device was genuine or fake. Results: The correct judgment rate was 51.2% (compared to 50% random guessing, 2-factor test P=0.84), and the Bang blinding index was -0.04 (95% CI: -0.20 to 0.12), indicating that the operators could not distinguish between genuine and fake devices at a higher level than random guessing.

[0107] Verification 2: Subject Blinding Test. In the formal RCT of 150 participants, a structured questionnaire was used after the last treatment to assess participants' guesses about the type of local intervention they received. Results: In the real FC group, sham FC group, and ANT group (all receiving sham FC), the proportions of participants guessing "I received real FC" were 58%, 52%, and 47%, respectively. There was no statistically significant difference among the three groups (χ²=2.14, P=0.34). The James blinding index was 0.67 (95% CI: 0.55–0.79), indicating successful subject blinding.

[0108] Verification 3: Odor Indistinguishability Test. The triangulation method (ISO 4120:2004 standard) was used. Thirty healthy volunteers were recruited, each undergoing three sets of triangulation tests (90 tests in total). Each set included two heated odor samples from a dummy device and one heated odor sample from a real fire dragon pot (or vice versa), requiring them to identify the different samples. Results: The correct identification rate was 34.4% (no significant difference compared to the random guess probability of 33.3%, P=0.72), indicating that human olfaction cannot reliably distinguish the odors of real and dummy devices.

[0109] Verification 4: GC-MS Analysis of Outlet Gas. Under standard operating conditions (heated to 42°C for 20 minutes), the outlet gas from the dummy device and the actual fire dragon tank was collected using a Tenax TA adsorption tube and analyzed by thermal desorption-GC-MS (Agilent 7890B / 5977A MSD). The results are shown in the table below:

[0110]

[0111] The results showed that the dummy device's outlet gas did not contain characteristic markers of Artemisia argyi combustion (eucalyptol, camphor, thujone, and caryophyllene were all <1 ppm detection limit); there was no significant difference in the contents of α-pinene (a common component of sandalwood powder / Artemisia argyi) and cinnamaldehyde (a common component of cinnamon powder / cinnamon twig) in the outlet gas of the two devices. These results confirm the "pharmacological inertness" of the dummy device—it does not produce pharmacologically active compounds specific to Artemisia argyi combustion at the chemical level.

[0112] Verification 5: Skin Temperature Safety. Thirty healthy volunteers (inner forearm skin) underwent standard 20-minute procedures of both real and sham FC (focal fovea). Skin surface temperature was continuously monitored using an infrared thermal imager (FLIR T540, accuracy ±1℃). Results: In the sham FC group, the highest skin surface temperature was 42.3±0.8℃, the average temperature was 40.5±1.2℃, and no temperature exceeding 44℃ was recorded. In the real FC group, the temperature was dynamically adjusted by the operator based on the participant's feedback; the instantaneous peak skin surface temperature reached 48-52℃ (single peak duration <5 seconds), with an average temperature of 41.8±2.5℃. No participants in the sham FC group experienced skin erythema lasting longer than 30 minutes, blisters, or pain complaints.

[0113] III. Examples of Clinical Trial Applications

[0114] The aforementioned dummy cupping device has been successfully applied in a two-center, double-blind, double-dummy, three-arm randomized controlled clinical trial jointly conducted by a maternal and child health hospital and a traditional Chinese medicine hospital (trial registration number: ChiCTR2100048623, ethics approval number: SFYLS2018-062). This trial randomly assigned 150 patients with acute lactational mastitis to three groups (50 patients per group): (A) real cupping and oral placebo group; (B) dummy cupping and oral placebo group; (C) dummy cupping and oral flucloxacillin 500mg qid group. Local treatment was administered every two days for a total of three times (Day 0 / 2 / 4), and oral medication was administered for 10 consecutive days.

[0115] During the trial, all operators used a coding device (the codes were generated and sealed by an independent statistician), standardized operating scripts, and infrared temperature measurements every 5 minutes, along with a checklist. Blinded evaluation results (see Validation 1-2 above) confirmed the effectiveness and reliability of the dummy device in a real clinical trial setting.

[0116] The above is a further detailed description of the present invention and should not be considered as a limitation on the specific implementation of the present invention. For those skilled in the art, simple deductions or substitutions without departing from the concept of the present invention are all within the protection scope of the present invention.

Claims

1. A device for clinical trials of fire dragon cupping, characterized in that, include: outer shell; An electric heating element, wherein the electric heating element is disposed inside the housing; An insulating metal film is disposed between the electric heating element and the skin contact side, and the thickness of the insulating metal film is 0.2mm-0.5mm; An inert visual and olfactory simulation material layer is filled in the cavity between the inner wall of the outer shell and the insulating metal film.

2. The device for clinical trials of Huolongguan (a type of traditional Chinese medicine) according to claim 1, characterized in that, The insulating metal film is made of stainless steel, aluminum alloy, or titanium alloy; the insulating metal film is used to limit deep heat penetration, block the diffusion of simulated gas from burning moxa wool to the skin, and provide electrical safety isolation.

3. The device for clinical trials of Huolongguan (a type of traditional Chinese medicine) according to claim 1, characterized in that, The inert visual and olfactory simulation material layer includes inert visual simulation material and inert olfactory simulation material; The inert visual simulation material is wood powder, which is selected from sandalwood powder or pine powder. The particle size of the wood powder is less than 180μm, and the amount of wood powder used is 12g-20g. The inert olfactory simulation material is an edible spice mixture, which is selected from one or more of cinnamon powder, ginger powder and dried tangerine peel powder. The amount of cinnamon powder used is 1g-3g, the amount of ginger powder used is 0.5g-2g, and the amount of dried tangerine peel powder used is 0.5g-2g.

4. The device for clinical trials of Huolongguan (a type of traditional Chinese medicine) according to claim 1, characterized in that, It also includes a temperature sensor and a temperature control module. The temperature sensor is located inside the insulating metal film, and the temperature control module is used to maintain the skin surface temperature at 40℃-42℃ and set the overheat automatic power-off threshold to 44℃.

5. The device for clinical trials of Huolongguan (a type of traditional Chinese medicine) according to claim 1, characterized in that, The electric heating element is a positive temperature coefficient ceramic heating element, the rated power of the electric heating element is 12W-18W, and the Curie temperature of the positive temperature coefficient ceramic heating element is set to 80℃-100℃.

6. The apparatus for clinical trials of Huolongguan (a type of traditional Chinese medicine) according to claim 1, characterized in that, The insulating metal film is fixed to the inner edge of the cup mouth of the outer shell by a silicone sealing ring. The silicone sealing ring is made of high-temperature resistant medical-grade material and has a temperature resistance of not less than 200°C.

7. The device for clinical trials of Huolongguan (a type of traditional Chinese medicine) according to claim 1, characterized in that, It also includes a power supply module, which is a built-in rechargeable lithium-ion battery that provides continuous power for no less than 45 minutes.

8. A system for clinical trials of fire dragon cupping, characterized in that, Includes the device according to any one of claims 1 to 7, as well as an operator training manual, standardized operating scripts, and a fidelity checklist for each treatment.

9. The use of any one of claims 1 to 7 in the preparation of a sham-controlled device for randomized controlled clinical trials.

10. The application according to claim 9, characterized in that, The randomized controlled clinical trial is a clinical trial targeting traditional moxibustion therapy, which includes any one or more of the following: medicated moxibustion, ginger-separated moxibustion, garlic-separated moxibustion, thunder-fire moxibustion, or Taiyi Divine Needle.

Images