34 results about "Placebo" patented technology

The application discloses a point application traditional Chinese medicine composition with an effect of treating irritable bowel syndrome, a point application plaster and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The application provides a point application traditional Chinese medicine composition and a point application plaster. The traditional Chinese medicine composition comprises the following components: psoralea, radix codonopsis, dried zedoary, fried atractylodes, mace, schisandra chinensis and evodia. The composition is prepared according to the principle of less medicine and special function and treatment of disease and seeking the origin. The core tonifying medicine, psoralea, dried zedoary and radix codonopsis, has a prominent dosage proportion and remarkable effects of warming the spleen and kidney yang and invigorating the spleen and replenishing qi. The application finds through clinical research that the clinical total effective rate of the test group is 76.7%, the curative effect is accurate and better than that of a placebo, the IBS-SSS score, the TCM syndrome score and the stool character score of IBS patients can be reduced, the symptoms of the patients are improved, and the composition can effectively treat IBS.

The invention provides an application of combined use of xanthan gum, soya bean lecithin and a bitter agent in a bitter placebo matrix used in a traditional Chinese medicine decoction. The invention provides a placebo matrix composition capable of simulating the aftertaste of a traditional Chinese medicine decoction. The decoction comprises the following raw materials in percentage by weight: 0.03-0.04% of a bitterness agent, 0.05-0.2% of xanthan gum and 1.5-3% of soybean lecithin. The invention further provides the modified rheum officinale and coptis chinensis gargle placebo. Aiming at the defects that only instantaneous bitter taste can be generated by simply adding a bitterness agent and the bitter taste fades quickly in the prior art, the invention provides a method capable of actively regulating and remarkably prolonging the bitter taste sensing duration, so that the placebo can realistically reproduce a complete time-intensity curve of'bitter taste in mouth-lasting bitter taste after mouth 'of a traditional Chinese medicine decoction; therefore, the testee is prevented from being broken by bitterness lasting time difference. The method breaks through the limitation of traditional solution simulation, and aims to provide a new thought for preparation of traditional Chinese medicine placebo, further improve the sensory simulation level of the placebo and provide a method and reference for research of similar placebo.

Blinding Device for Injection Devices In one aspect the present disclosure relates to a blinding device (50) for concealing an injection device (1) in clinical trials, wherein the injection device (1) comprises a movable plunger (20) and an elongated barrel (10) extending in a longitudinal direction (2, 3) and filled with a medicament (8) or with a placebo, wherein the plunger (20) is longitudinally movable relative to the barrel (10) for expelling the medicament (8) or the placebo from the barrel (10) and wherein the injection device (1) comprises a flange portion (17, 18) at or near a proximal end of the barrel (10), the blinding device (50) comprising: - an opaque housing (52) to cover the barrel (10) and the plunger (20), the opaque housing (60) comprising: - a barrel cover portion (54) to receive and to cover the barrel (10), - a plunger cover portion (56) of variable longitudinal extent to receive and to cover the plunger (20), and - a housing flange portion (55) protruding outwardly from the barrel cover portion (54), wherein the housing flange portion (55) comprises a first flange part (61) and a second flange part (62), which are mutually connectable to form a flange assembly (66) connecting the barrel cover portion (54) with the plunger cover portion (56). (Fig. 1)

Disclosed herein are delivery devices for delivering a volume of a drug product, placebo product, or other product including a fluid. The devices may include a barrel having a longitudinal axis, a proximal end region, and a distal end region. The proximal end region may include an opening, and the barrel may be configured to receive a drug therein. A plunger rod may be disposed at least partially inside the barrel and protruding from the opening. The plunger rod may include a rack having a plurality of teeth. The device may further include a pinion having a plurality of teeth configured to engage with the plurality of teeth of the rack, and rotation of the pinion against the rack may move at least a part of the plunger rod along the longitudinal axis of the barrel.

This invention relates to methods and compositions useful in subjects suffering from or at risk of suffering from sepsis or other dysregulated inflammatory responses. It has been demonstrated that the CETP inhibitor obicetrapib not only preserved or increased HDL-C and Apo A1 levels, but also reduced an important pro-inflammatory marker, IL-1β, and significantly increased survival, relative to placebo, in a suitable sepsis mouse model. Thus, broadly stated, the present invention concerns the use of CETP inhibitors in the prevention, treatment, management or amelioration of sepsis, or other dysregulated inflammatory responses in a subject.

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cerebral hemorrhage and application thereof. The traditional Chinese medicine composition comprises the following main active components in parts by mass: 10-30 parts of red ginseng, 10-20 parts of rheum officinale, 0.5-1 part of processed semen strychni, 1-10 parts of leech and 10-30 parts of pseudo-ginseng. Clinical tests show that 24 hours after cerebral hemorrhage attacks, the traditional Chinese medicine composition can obviously improve uw-mRS and mRS of cerebral hemorrhage patients for 90 days, obviously improve the poor prognosis of the cerebral hemorrhage patients and improve the independent living ability. Meanwhile, compared with a placebo group, the traditional Chinese medicine compound group for treating related adverse events has no significant difference (Pgt; 0.05), which indicates that the traditional Chinese medicine composition disclosed by the invention is good in safety. The results show that the traditional Chinese medicine composition can effectively treat cerebral hemorrhage and is good in safety.

The present disclosure provides methods for treating or managing fibromyalgia and its associated symptoms in a subject in need hereof characterized by an early onset of one or more of: (1) a reduction in widespread pain characterized by about 0.3 or more difference in the LS mean change in the NRS Pain Score; (2) a reduction in sleep disturbance characterized by about 2.9 or more difference in the LS Mean change in PROMIS Sleep Disturbance T-score; (3) a reduction in fatigue characterized by about 2.0 or more difference in the LS Mean change in PROMIS Fatigue T-score; or (4) an improved sleep quality characterized by about 0.5 or more difference in the LS Mean change in NRS Sleep Quality Score, each as compared to placebo, comprising administering to a subject in need thereof 2.8 mg or 5.6 mg cyclobenzaprine HCl once daily in one or more dosage units by transmucosal administration. The present disclosure also provides methods for preventing or avoiding one or more of a clinically meaningful change in mean weight, a clinically meaningful change in mean systolic blood pressure or mean diastolic blood pressure, or a decline in sexual functioning in conjunction with treating or managing fibromyalgia or its associated symptoms in a subject in need thereof, the treatment or management being characterized by the transmucosal administration of cyclobenzaprine HCl in one or more dosage units (e.g., a first dosage unit or a second dosage unit). The cyclobenzaprine HCl of these methods is in the form of a mannitol eutectic (e.g., a 75%±2% by weight cyclobenzaprine HCl and 25%±2% by weight β-mannitol eutectic) and the one or more dosage units further comprise a basifying agent.

The invention provides an experimental method for verifying the curative effect of retinoic acid on schizophrenia, which comprises the following steps: step 1, selecting two groups of pregnant SD rats, injecting Poly I: C into tail veins of one group of SD rats after 9.5 days of pregnancy according to the standard of 10 mg / kg, and taking male offspring rats as schizophrenia model group rats; the other group of SD rats are intravenously injected with equal-volume normal saline at the tail after pregnancy 9.5 days, and the male offspring rats are the control group; 2, the model components are divided into two groups, retinoic acid is fed to one group 45 days after birth according to the standard of 3 mg / kg / day, an equal amount of placebo is injected to the other group, and an equal amount of placebo is injected to the control group; step 3, carrying out behavioral detection experiments on the three groups of rats in the step 2; and 4, implanting electrodes into hippocampal CA1 regions of the three groups of rats in the step 2, and recording and analyzing electroencephalogram activities of the three groups of rats. The experimental method provided by the invention proves that the retinoic acid has good application value in preparation of the schizophrenia medicine.

The utility model discloses a needling auxiliary device, and belongs to the technical field of needling auxiliary devices. The needling auxiliary device comprises a base assembly and a needling instrument assembly. The base assembly comprises a first transparent base and a second transparent base, peep-proof layers are arranged on the outer sides of the first transparent base and the second transparent base, a first through hole is formed in the first transparent base, and a second through hole is formed in the second transparent base; the needling instrument assembly comprises an acupuncture needle and a placebo needle, the acupuncture needle penetrates through the first through hole, and the placebo needle penetrates through the second through hole. According to the acupuncture auxiliary device, the treatment efficiency and effect of the acupuncture needle and the placebo needle are effectively improved, and the situation that a subject observes whether the acupuncture needle or the placebo needle is punctured into the acupuncture point or not, and consequently the accuracy of a test result is affected can be avoided.

The present disclosure provides a method of treating or inducing cognitive preservation in a patient with Alzheimer's disease, comprising administering an effective amount of CT1812. The effective amount of CT1812 is 100 mg or 300 mg administered orally once daily. The method demonstrates improvements in cognitive outcomes compared to placebo across multiple measures including ADAS-Cog11, MMSE, ADCS-ADL, and ADCS-CGIC. The method demonstrates improvements in cognitive outcomes in patients with low plasma levels of phosphorylated tau 217 prior to administration.

The present disclosure provides methods for treating or managing fibromyalgia and its associated symptoms in a subject in need hereof characterized by an early onset of one or more of: (1) a reduction in widespread pain characterized by about 0.3 or more difference in the LS mean change in the NRS Pain Score; (2) a reduction in sleep disturbance characterized by about 2.9 or more difference in the LS Mean change in PROMIS Sleep Disturbance T-score; (3) a reduction in fatigue characterized by about 2.0 or more difference in the LS Mean change in PROMIS Fatigue T-score; or (4) an improved sleep quality characterized by about 0.5 or more difference in the LS Mean change in NRS Sleep Quality Score, each as compared to placebo, comprising administering to a subject in need thereof 2.8 mg or 5.6 mg cyclobenzaprine HCl once daily in one or more dosage units by transmucosal administration. The present disclosure also provides methods for preventing or avoiding one or more of a clinically meaningful change in mean weight, a clinically meaningful change in mean systolic blood pressure or mean diastolic blood pressure, or a decline in sexual functioning in conjunction with treating or managing fibromyalgia or its associated symptoms in a subject in need thereof, the treatment or management being characterized by the transmucosal administration of cyclobenzaprine HCl in one or more dosage units (e.g., a first dosage unit or a second dosage unit). The cyclobenzaprine HCl of these methods is in the form of a mannitol eutectic (e.g., a 75% ± 2% by weight cyclobenzaprine HCl and 25% ± 2% by weight β‑mannitol eutectic) and the one or more dosage units further comprise a basifying agent.

The present invention provides compounds for use in the treatment of pulmonary diseases, particularly asthma, wherein the compounds bind to the cytokines IL-13 and TSLP. The treatment according to the invention is capable of reducing the level of exhaled nitric oxide (FeNO) by at least 18 ppb compared to placebo. The treatments of the invention are also capable of reducing eosinophil count, increasing FEV1 and / or reducing airway inflammation.

Aspects of the present disclosure relate to machine learning (ML) model governance. A first ML output can be received from a first version of a ML model based on a first prompt. The first version of the ML model can be trained on placebo data to obtain a second version of the ML model. A second ML output can be received from the second version of the ML model trained on the placebo data based on the first prompt. A validation result can be received based on a comparison between the first ML output and the second ML output.

The invention relates to the technical field of medicines, and particularly discloses a Naoxuekang dropping pill placebo as well as a preparation method and application thereof. The Naoxuekang dropping pill placebo provided by the invention is prepared from the following components in parts by weight: 7000 to 13000 parts of matrix, 100 to 600 parts of pigment and 50 to 300 parts of compound essence, the matrix is polyethylene glycol; the pigment is caramel pigment; the compound essence is prepared by mixing propionic acid, isovaleric acid, 2-methylpyrazine, p-cresol, 2, 3-dimethylpyrazine, limonene and propylene glycol. The raw and auxiliary materials used in the application are safe, non-toxic and harmless, and the prepared Naoxuekang dropping pill placebo has high consistency with a tested raw medicine sample in the aspects of pill weight, appearance, color, smell, taste and other characters, and can be clinically used as a placebo.

The application provides a method and device for determining a color matching scheme of a traditional Chinese medicine placebo and a placebo preparation method. The method mainly comprises the following steps: providing color information of a target traditional Chinese medicine preparation to a pre-trained traditional Chinese medicine color clustering model to determine a corresponding clustering cluster of the target traditional Chinese medicine preparation, and selecting a color matching prediction model corresponding to the clustering cluster from a plurality of pre-trained color matching prediction models; and providing the extracted color information to the selected color matching prediction model to obtain a color matching scheme of a placebo corresponding to the target traditional Chinese medicine preparation. The solution of the application can more quickly and accurately obtain a color matching scheme of a traditional Chinese medicine placebo, thereby improving the preparation speed and efficiency of the traditional Chinese medicine placebo.

The invention belongs to the technical field of medicines, and particularly provides a high-simulation placebo as well as a preparation method and application thereof in combined treatment of menopausal syndrome by traditional Chinese medicine and western medicine. The high-simulation placebo is prepared from the following components in parts by mass: caramel color, citrus yellow, citric acid, malic acid, raw medicine extract and the balance of maltodextrin. The high-simulation placebo is applied to a traditional Chinese and western medicine combined medication scheme, the unique advantages of western medicines and traditional Chinese medicines are deeply fused, and the weakness of a single therapy is ingeniously avoided. Western medicines can quickly relieve clinical symptoms of MPS patients by virtue of the characteristics of quick action and clear target spot; the traditional Chinese medicines have the effects of overall conditioning, mildness and durability, so that the body function of a patient is fundamentally improved, and the immunity is enhanced. The two components supplement each other, and the composition has obvious results in improvement of clinical symptoms of MPS patients and improvement of life quality, and can be clinically popularized.

The present invention relates to a composition for the consumption of a subject. The composition comprising piracetam as a monitoring marker for the composition and a substance. The substance is an active pharmaceutical ingredient (API), a placebo material, or a consumer substance. The present invention also relates to use of the composition and methods of monitoring a subject.

This application discloses a method for testing the non-inferiority of a new drug when efficacy data follows a skewed normal distribution. This method tests the non-inferiority of a new drug relative to a standard drug when efficacy data follows a skewed normal distribution, ensuring the reliability of the test results. S1. Acquisition of drug efficacy data in clinical trials: In a three-arm non-inferiority clinical trial, drug efficacy data are acquired from three groups of clinical trial results—the new drug group, the standard drug control group, and the placebo control group—based on drug efficacy indicators. The efficacy data follows a skewed normal distribution. S2. Calculation of the probability of committing a Type I error: In the three-arm non-inferiority hypothesis testing model, the probability of committing a Type I error is calculated using a frequentist method or a Bayesian method on the drug efficacy data from the three groups of trials. The probability of committing a Type I error is the probability of the alternative hypothesis H1 occurring when the null hypothesis H0 is true. S3. Determination of the non-inferiority of the new drug: If the probability of committing a Type I error is greater than a given reference value, the new drug is determined to be non-inferior to the standard drug. The reference value is a pre-given clinically significant threshold value.

The disclosure provides methods of treating neurodegenerative conditions, for example, amyotrophic lateral sclerosis, using a regimen of a chlorite salt, for example, sodium chlorite. The long-term survival of subjects receiving sodium chlorite and placebo are compared.

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a radix bupleuri liver soothing powder placebo as well as a preparation method and an evaluation method thereof. The placebo comprises a radix bupleuri liver soothing powder stock solution, pigment, dextrin, a flavoring agent, essence and a suspending aid. The placebo highly similar to the radix bupleuri liver soothing powder raw medicine is prepared by simulating color, clarity, taste and smell and combining with the optimization of a suspending aid. The placebo is suitable for clinical test control, and scientificity and reliability of test results are ensured.

The present invention provides compounds for use in the treatment of lung diseases (particularly asthma), which bind to the cytokines IL-13 and TSLP. Treatment according to the present invention can reduce exhaled nitric oxide (FeNO) levels by at least 18 ppb compared to placebo. Treatment according to the present invention can also reduce eosinophil count, increase FEV1, and / or reduce airway inflammation.

The invention discloses application of PQQ in preparation of a menstrual cycle disorder regulator. Preliminary experimental data show that compared with placebo, oral administration of PQQ has a significant effect on prevention, alleviation or treatment of menstrual cycle disorder.

The invention provides a placebo of bitter wine soup powder, which is prepared from the following raw materials in parts by weight: 2,080 to 3,120 parts of filling agent, 60 to 90 parts of turbid agent, 0.0704 to 0.1056 part of pigment, 40 to 60 parts of tackifier, 107.2 to 160.8 part of taste auxiliary material, 44.2 to 66.3 parts of smell auxiliary material and 67.84 to 101.76 parts of foaming agent. The invention also provides a preparation method of the placebo of the bitter wine soup powder and a simulation degree evaluation method. A percolation process is screened as an optimal extraction process through radioactive oral mucosa animal experiments; further systematic optimization is carried out on an extraction-freeze-drying-taste modifying process, so that'ready-to-use and ready-to-prepare 'type bitter wine soup powder is successfully prepared; the high-simulation placebo is developed on the basis of multi-dimensional sensory characteristics of bitter wine soup powder in shape, color, smell, taste and the like. According to the evaluation method, raw medicine similarity evaluation is carried out on the powder, the dissolution behavior and the solution appearance of the placebo respectively, the three states are simulated synchronously, and in order to solve the problem that the solubility of the raw medicine powder and the placebo is poor, improvement is carried out through a freeze-drying protective agent and micronization, so that the raw medicine powder and the placebo are similar; in addition, the appearance and physicochemical properties of a solution obtained after the raw medicine is dissolved are special, and simulation optimization is carried out.

The invention relates to the technical field of medical data processing, and discloses a drug curative effect evaluation method, system, equipment and medium. Based on drug group clinical test data and placebo group clinical test data of a to-be-evaluated drug, an accurate drug curative effect index is calculated for the to-be-evaluated drug; and quantitative drug curative effect evaluation of the to-be-evaluated drug is realized. According to the method, the drug curative effect index is calculated, the drug curative effect is converted into a quantifiable index, and the objectivity and the accuracy of an evaluation result are remarkably improved. Through comprehensive analysis of clinical test data of a drug group and a placebo group, cross-disease and cross-population drug curative effect evaluation can be realized, for example, not only can the curative effect of the drug in a single disease be evaluated, but also the curative effect evaluation of different disease systems can be expanded, so that more comprehensive drug curative effect data can be provided. The invention provides a systematic and precise new tool for evaluating the curative effect of the medicine, and has important clinical application and research and development values.

The application provides a compound medicine for relieving cough and asthma in atomization treatment of respiratory system and a preparation and application thereof. The medicine is prepared from white ginkgo, ephedra and other Chinese medicinal materials as main raw materials, and further comprises complex bacteria, an osmotic pressure regulator and a dissolving agent. The complex bacteria are composed of cordyceps sinensis, bamboo lotus and pine olive in a specific mass ratio, the osmotic pressure regulator is glucose and glycerol in a specific ratio, and the dissolving agent can be selected from multiple kinds. The preparation method comprises multiple steps, including unique processes such as extraction of medicinal materials, salt modification and ultrasonic extraction. Through clinical tests, compared with a control group and a placebo group, the compound medicine can significantly improve the lung function related indexes of patients, reduce the inflammatory factor level, and effectively relieve the cough and asthma symptoms through a visual analogue scale method. The medicine can be used for preparing an atomization inhalation medicine for treating bronchial asthma, chronic obstructive pulmonary disease and other respiratory diseases, and has a good application prospect.

The invention discloses a compound scutellaria baicalensis and orchid oral liquid placebo and a preparation method thereof, and belongs to the technical field of medicines. The technical problem to be solved is to provide the compound scutellaria baicalensis and orchid oral liquid placebo which is good in taste, similar in appearance and free of peculiar smell. According to the technical scheme, the compound scutellaria baicalensis and orchid oral liquid placebo is characterized by being prepared from, by weight, 60-70 parts of compound scutellaria baicalensis and orchid extract, 45-55 parts of thickening agent, 0.4-0.6 part of bitter agent, 45-55 parts of sweetening agent, 3-4 parts of coloring agent and 2.7-3 parts of preservative, and the bitter agent is sucrose octaacetate.

The invention relates to the field of medicines, in particular to a donkey-hide gelatin compound oral liquid placebo and a preparation method thereof. The colla corii asini compound oral liquid placebo comprises colla corii asini compound oral liquid raw medicine, coffee essence, scorched essence, a sour agent, a sweetening agent, a bitter agent, a thickening agent, pigment and optional water, and preferably comprises colla corii asini compound oral liquid raw medicine, coffee essence, scorched essence, mature vinegar, rock candy, sucrose octaacetate, soluble starch and caramel pigment. And optionally water. The colla corii asini compound oral liquid placebo is similar to a test medicine colla corii asini compound oral liquid in the aspects of appearance, color, taste, smell and the like, and can be used for preventing blurring to the greatest extent, so that smooth proceeding of a clinical test is ensured.

The invention relates to a consolation capsule placebo capable of effectively solving the preparation problem of the consolation capsule placebo capable of reinforcing vital essence and dredging brain. The black rice cake is prepared from fried flour, dextrin, fried black rice flour, fried wheat bran, liquid caramel color, 60-mesh cane sugar, table salt, ginger oil, star anise oil, ethyl maltol, DL-malic acid, talcum powder and 80-mesh cane sugar. The preparation method comprises the following steps: taking fried flour, dextrin, fried black rice flour and fried wheat bran as matrixes, taking liquid caramel color as a pigment, adding 60-mesh cane sugar, table salt and DL-malic acid into ethanol to prepare a solution, boiling, granulating, and sieving for later use; the preparation method comprises the following steps: adding the ginger oil, the star anise oil and the ethyl maltol into 80-mesh cane sugar, grinding into powder, adding the ground powder and the residual 80-mesh cane sugar into boiling granulation, adding the talcum powder, mixing, and filling into capsules, thereby obtaining the product. Any medicinal material in the vigor-reinforcing and brain-dredging capsule is not adopted, so that the capsule has no pharmacological activity and does not exert the drug effect, the simulation of the drug is realized, and the clinical test blindness is effectively avoided; the preparation process is simple, convenient to operate and high in practical value.

The invention discloses a high-simulation bear gall placebo based on a bionic photosensitive technology and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The technical problem to be solved is that the existing traditional Chinese medicine type bear gall placebo possibly interferes with the observation of the safety and effectiveness of the test medicine. The high-simulation bear gall placebo comprises the effective components of food coloring, sucrose octaacetate, maltodextrin and edible essence, and effective interference possibly generated by prescription materials is reduced to the maximum extent. The newest sensory bionic technology is used for evaluation in the technical development stage and the large-scale application stage, and compared with previous manual evaluation, the result is objective, quantifiable, scientific and more accurate.

This application provides a placebo of the traditional Chinese medicine compound Ge Gen Qin Lian Tang decoction. The placebo comprises a matrix, pigments, flavorings, and flavoring agents: the matrix includes buckwheat flour, sodium carboxymethyl cellulose, and potassium sorbate; the pigments include caramel coloring, yellow pigment, and carmine red pigment; the flavorings include kudzu root flavoring, caramel flavoring, and green tea flavoring; and the flavoring agents include sucrose octaacetate, disodium inosinate, and sugar alcohols. This placebo is similar in color, odor, and taste to the traditional Chinese medicine compound Ge Gen Qin Lian Tang decoction, meeting the blinding requirements in clinical trials. Even if patients are exposed to the investigational drug, it is unlikely that the blinding will be broken, making it suitable for clinical trials treating type 2 diabetes.