Traditional Chinese medicine composition for improving perineal pain

Abstract

The invention provides a traditional Chinese medicine composition for improving perineal pain. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6-15 parts of radix ligustici sinensis, 6-15 parts of tribulus terrestris and 6-15 parts of lily. The ligusticum, the tribulus terrestris and the lily can dispel depression and relieve pain, and the ligusticum, the tribulus terrestris and the lily complement each other to play a role. Through compatibility, from three angles of cold dispelling, blood activating and depression relieving, the pain relieving effect is jointly achieved, the direction is clear, the effect is specific, a pain source is directly hit, and the medicine is used for improving perineal pain.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for relieving perineal pain. Background Technology

[0002] Perineal pain syndrome is a refractory disease characterized by chronic pain in the perineal region (the triangle between the anus and external genitalia). It is a common chronic pain syndrome in clinical practice, involving multiple disciplines such as andrology, urology, gynecology, and proctology. It affects a wide range of people, including women of childbearing age, the elderly, and patients in postoperative recovery, and has become a significant public health issue impacting patients' quality of life. The causes of perineal pain are complex and diverse, mainly including prostatitis, pelvic pain syndrome, pelvic floor muscle dysfunction, neurogenic injury, sequelae of infectious diseases, childbirth or surgical trauma, and chronic inflammatory stimulation. Clinical manifestations are mostly persistent or intermittent dull pain, distending pain, and stabbing pain in the perineal area. Some patients may also experience complications such as urinary abnormalities, bowel discomfort, and sexual dysfunction, seriously affecting patients' daily activities, sleep quality, and mental health. Long-term illness can easily lead to anxiety, depression, and other emotional problems, placing a significant physical and mental burden and economic pressure on patients' families and society.

[0003] Currently, there is a lack of unified and standardized treatment protocols for perineal pain in clinical practice. Existing treatments are mostly symptomatic, including oral nonsteroidal anti-inflammatory drugs (NSAIDs), topical analgesics, nerve blocks, and physical therapy. However, these treatments all have significant limitations: oral medications can easily cause adverse reactions such as gastrointestinal irritation and liver and kidney damage, and long-term use can lead to drug resistance and a gradual weakening of the analgesic effect; topical medications can only relieve superficial pain and are difficult to reach deeper tissues, resulting in short-lived effects; nerve blocks and physical therapy are complex to perform, require specialized equipment and technical support, and have long treatment cycles and high recurrence rates, failing to address the root cause of the pain. Furthermore, some patients experience poor treatment outcomes due to unclear pain mechanisms or insensitivity to existing treatments, falling into a vicious cycle of "pain-anxiety-pain exacerbation," highlighting the growing contradiction between clinical needs and existing treatment options.

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in the treatment of chronic pain through holistic regulation and syndrome differentiation. By regulating the body's Qi and blood circulation, repairing tissue damage, and balancing organ functions, it can achieve a "both symptomatic and root-cause" therapeutic effect, with few adverse reactions, high safety, and suitability for long-term intervention. However, current research on TCM treatment for perineal pain is relatively fragmented, lacking standardized TCM compositions specifically developed for the etiology, pathogenesis, and syndrome characteristics of perineal pain. Existing clinically used TCM formulas are mostly general analgesics or anti-inflammatory agents, failing to fully integrate the core TCM pathogenesis of perineal pain, such as "meridian obstruction, Qi and blood stagnation, and damp-heat accumulation," resulting in weak targeting and unstable efficacy, failing to meet the urgent clinical need for safe, effective, and highly targeted TCM treatment plans.

[0005] Therefore, based on the clinical characteristics of perineal pain and years of clinical practice, developing a scientifically formulated, targeted, safe and effective traditional Chinese medicine composition to compensate for the shortcomings of existing treatments, provide new treatment options for patients with perineal pain, and achieve complementary advantages between traditional Chinese and Western medicine has important clinical value and application prospects, and has become an urgent technical problem to be solved. Summary of the Invention

[0006] The technical problem this invention aims to solve is to address the shortcomings of the prior art by providing a traditional Chinese medicine composition for improving perineal pain. This composition contains Ligusticum striatum for dispelling cold and relieving pain, Tribulus terrestris for promoting blood circulation and relieving pain, and Lilium brownii for relieving depression and pain; the three ingredients work synergistically to exert their effects. This invention, through its formulation, works from three angles—dispelling cold, promoting blood circulation, and relieving depression—to exert a combined analgesic effect. The direction is clear, the effect is specific, and it directly targets the source of pain, thus improving perineal pain.

[0007] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is: a traditional Chinese medicine composition for improving perineal pain, which is composed of the following raw materials in parts by weight: 6 to 15 parts of Ligusticum striatum, 6 to 15 parts of Tribulus terrestris and 6 to 15 parts of Lilium brownii.

[0008] Preferably, it is composed of the following raw materials in parts by weight: 10 parts of Ligusticum striatum, 10 parts of Tribulus terrestris and 10 parts of Lilium brownii.

[0009] Ligusticum striatum, dispelling wind and cold, eliminating dampness and relieving pain. It can inhibit inflammation and exert analgesic effects. It can improve local blood circulation, inhibit the activation of pain-related pathways, and exert analgesic effects. The Shennong's Classic of Materia Medica states that "Ligusticum striatum is pungent and warm. It mainly treats cold swelling and pain in the genitals," indicating that Ligusticum striatum can treat cold, swelling, and pain in the genitals. Ligusticum striatum enters the bladder meridian. The Pharmacopoeia of Materia Medica states that "this is a wind-dispelling medicine for the Taiyang meridian." The Pearl Bag states that it enters the Foot Taiyang Bladder and Hand Taiyang Small Intestine meridians. The Compendium of Materia Medica states that it "enters the bladder and also enters the Du meridian." Moreover, the Hand Taiyang Small Intestine meridian intersects with the Du meridian at the Houxi acupoint. Therefore, Ligusticum striatum can also enter the Taiyang and Du meridians. Thus, the Compendium of Materia Medica states that "Ligusticum striatum is ascending and belongs to Yang. It is used for cold stagnation in the Foot Taiyang meridian, causing headache, neck, and vertex pain... It is also frequently used for genital swelling and hernia pain in women, when the Du meridian is affected, causing stiffness and cold extremities." Therefore, Ligusticum striatum enters the perineum through the Du meridian to relieve pain.

[0010] Tribulus terrestris, also known as thorn, soothes the liver and relieves depression, invigorates blood and dispels wind. It inhibits pain signal transmission, exerting an analgesic effect. It also inhibits inflammatory responses, exerting an analgesic effect. It regulates both the central and peripheral nervous systems, exerting a dual analgesic effect. The *Compendium of Materia Medica* states, "Tribulus terrestris... its nature is to promote circulation and facilitate digestion, it can move and eliminate stagnation of qi in the liver and spleen, and prolonged use can remove stagnation." Tribulus terrestris enters the liver meridian, which "follows the groin, enters the pubic hair, passes the genitals, and reaches the lower abdomen." Furthermore, the liver meridian intersects with the Ren meridian at "Qugu," "Zhongji," and "Guanyuan," with the Du meridian at "Baihui," and with the Chong meridian at "Sanyinjiao." Tribulus terrestris connects to the perineum via the Du, Ren, Chong, and liver meridians. The *Jade Autumn Materia Medica* records that it "soothes the liver and dispels wind, treats the leakage of liver qi," thus Tribulus terrestris can remove stagnation in the perineum.

[0011] Lily nourishes Yin and moistens the lungs, calms the mind and soothes the nerves. It can significantly reduce the level of inflammatory factors and relieve pain. It has a significant sedative effect. The white color of lily enters the lung meridian, and the Lung Meridian of Hand-Taiyin intersects with the Ren Meridian at the Lieque acupoint, thus it also enters the Ren Meridian. The *Mingyi Bielu* records that lily stops "pain throughout the body," and the *Beiji Qianjin Yaofang* records that the Lieque acupoint can treat "pain in the male genitals," therefore lily can enter the perineum via the Ren Meridian to relieve pain. Lily disease, named after the treatment that uses lily as the main ingredient, often presents with mental and psychological symptoms. The *Jinkui Yaolue* describes "wanting to eat but unable to, often silent, wanting to lie down but unable to, wanting to walk but unable to... feeling cold but not cold, feeling hot but not hot," clinically, patients with perineal pain often have emotional symptoms such as depression and anxiety. Western medicine also commonly uses analgesics and antidepressants. Therefore, using lily to treat perineal pain is a synergistic treatment.

[0012] Compared with the prior art, the present invention has the following advantages: 1. In this invention, Ligusticum striatum dispels cold and relieves pain, Tribulus terrestris invigorates blood and relieves pain, and Lilium brownii relieves depression and pain. The three herbs work synergistically to exert their effects. Through this combination, the invention exerts its analgesic effect from three perspectives: dispelling cold, invigorating blood, and relieving depression. The effect is clear, specific, and directly targets the source of pain, thus improving perineal pain.

[0013] 2. The traditional Chinese medicine composition of the present invention has significant clinical effects, a high clinical cure rate, a wide range of indications, rapid onset of action, few side effects, and is inexpensive.

[0014] The present invention will be further described in detail below with reference to the embodiments. Detailed Implementation

[0015] Example 1 The traditional Chinese medicine composition for improving perineal pain in this embodiment is composed of the following raw materials: 10g of Ligusticum striatum, 10g of Tribulus terrestris and 10g of Lilium brownii.

[0016] Mr. Wang, male, 45 years old, date of consultation: December 3, 2023.

[0017] Chief complaint: Perineal distending pain for 10 months. Red tongue with little coating, wiry and rapid pulse. Urinalysis showed no obvious abnormalities.

[0018] Traditional Chinese Medicine diagnosis: perineal pain.

[0019] Prescription: The decoction made from the traditional Chinese medicine composition of this embodiment for improving perineal pain, 200mL / dose, one dose per day, decocted in water and taken twice a day, morning and evening.

[0020] Second visit: December 17, 2023. After taking the above prescription, the perineal distending pain was relieved, and the previous treatment was continued.

[0021] Third visit: December 31, 2023, perineal pain reduced by 70%, instructed to discontinue medication and observe.

[0022] Example 2 The traditional Chinese medicine composition for improving perineal pain in this embodiment consists of the following raw materials in parts by weight: 6g of Ligusticum striatum, 10g of Tribulus terrestris and 10g of Lilium brownii.

[0023] Mr. Yuan, male, 39 years old, date of consultation: May 28, 2025.

[0024] Chief complaint: Perineal pain for over two months. Current symptoms include perineal pain, urinary urgency, and incomplete urination. The tongue is enlarged with a thin, greasy coating. Urinalysis showed no significant abnormalities.

[0025] Traditional Chinese Medicine diagnosis: perineal pain.

[0026] Prescription: The decoction made from the traditional Chinese medicine composition of this embodiment for improving perineal pain, 200 mL / dose, one dose per day, decocted in water and taken twice a day, morning and evening.

[0027] Second visit: June 4, 2025, perineal pain lessened, continued medication.

[0028] Third visit: June 25, 2025. Perineal discomfort was significantly reduced, and urinary frequency and urgency were reduced. The original prescription was continued, and the patient was instructed to discontinue the medication for observation.

[0029] Example 3 The traditional Chinese medicine composition for improving perineal pain in this embodiment is composed of the following raw materials: 15g of Ligusticum striatum, 15g of Tribulus terrestris and 15g of Lilium brownii.

[0030] Mr. Shi, male, 36 years old, date of consultation: July 9, 2025.

[0031] Chief complaint: Hematospermia for over a year. The hematospermia was accompanied by significant perineal pain, and the symptoms recurred after taking other medications. The patient was treated with the traditional Chinese medicine composition described in this example for improving perineal pain. Upon follow-up visit, the hematospermia symptoms had gradually lessened. Tongue was red with a thin yellow coating, and pulse was wiry and thready.

[0032] Traditional Chinese Medicine diagnosis: perineal pain.

[0033] Prescription: The decoction made from the traditional Chinese medicine composition of this embodiment for improving perineal pain, 200 mL / dose, one dose per day, decocted in water and taken twice a day, morning and evening.

[0034] The patient reported a 70% reduction in perineal pain during a follow-up visit. The original prescription was continued for over two months. Seventh visit: November 5, 2025, perineal pain disappeared, and medication was discontinued.

[0035] Example 4 The traditional Chinese medicine composition for improving perineal pain in this embodiment consists of the following raw materials: 6g of Ligusticum striatum, 6g of Tribulus terrestris and 10g of Lilium brownii.

[0036] Mr. Jing, male, 34 years old, date of consultation: September 30, 2022 Chief complaint: Perineal pain for over a month. Pale tongue with white coating, wiry pulse. Urinalysis showed no obvious abnormalities.

[0037] Traditional Chinese Medicine diagnosis: perineal pain.

[0038] Prescription: The decoction made from the traditional Chinese medicine composition of this embodiment for improving perineal pain, 200mL / dose, one dose per day, decocted in water and taken twice a day, morning and evening.

[0039] Second visit: October 14, 2022. The patient reported that the perineal pain was significantly reduced the day after taking the above prescription. The original prescription was modified for treatment: Ligusticum striatum 10g, Tribulus terrestris 6g, and Lilium brownii 10g.

[0040] Third visit: October 28, 2022. All symptoms improved. The patient was advised to stop medication and observe.

[0041] Example 5 The traditional Chinese medicine composition for improving perineal pain in this embodiment is composed of the following raw materials: 6g of Ligusticum striatum, 6g of Tribulus terrestris and 6g of Lilium brownii.

[0042] Mr. Huang, male, 38 years old, date of consultation: September 10, 2025.

[0043] Chief complaint: Perineal stinging pain for 3 weeks. Red tongue with thin white coating, wiry pulse.

[0044] Traditional Chinese Medicine diagnosis: perineal pain.

[0045] Prescription: The decoction made from the traditional Chinese medicine composition of this embodiment for improving perineal pain, 200mL / dose, one dose per day, decocted in water and taken twice a day, morning and evening.

[0046] Second visit: Follow-up visit on September 24, 2025, the perineal pain had disappeared.

[0047] Example 6 The traditional Chinese medicine composition for improving perineal pain in this embodiment is composed of the following raw materials: 8g of Ligusticum striatum, 8g of Tribulus terrestris and 10g of Lilium brownii.

[0048] Mr. Wang, male, 36 years old, date of consultation: May 18, 2025.

[0049] Chief complaint: Perineal pain. Red tongue with a thin white coating, wiry pulse. Urinalysis showed no obvious abnormalities.

[0050] Traditional Chinese Medicine diagnosis: perineal pain.

[0051] Prescription: The decoction made from the traditional Chinese medicine composition of this embodiment for improving perineal pain, 200mL / dose, one dose per day, decocted in water and taken twice a day, morning and evening.

[0052] Second visit: June 25, 2025. Perineal pain was relieved, but aggravated by prolonged sitting. The original prescription was continued.

[0053] Third visit: July 16, 2025. Symptoms improved significantly. The patient was instructed to continue the original prescription and then discontinue medication for observation.

[0054] Example 7 The traditional Chinese medicine composition for improving perineal pain in this embodiment is composed of the following raw materials: 8g of Ligusticum striatum, 8g of Tribulus terrestris and 10g of Lilium brownii.

[0055] Mr. Zhang, male, 27 years old, date of consultation: June 4, 2023.

[0056] Chief complaint: Prostatitis for over 5 years, worsening in the past 2 months. Current symptoms include perineal pain and distending pain, erectile dysfunction, decreased morning erections, urinary frequency, incomplete urination, right lower abdominal distension, left varicocele, chest tightness, loose stools, and hunger pains. Tongue is pale red with a yellow, greasy coating. Urinalysis showed no significant abnormalities.

[0057] Traditional Chinese Medicine diagnosis: perineal pain.

[0058] Prescription: The decoction made from the traditional Chinese medicine composition for treating perineal pain in this embodiment, 200mL / dose, one dose per day, decocted in water and taken twice a day, morning and evening.

[0059] Second visit: June 18, 2023. Symptoms were relieved, perineal pain was relieved, Ligusticum striatum was reduced to 6 parts, Tribulus terrestris was increased to 15 parts, the rest remained unchanged, and continued to take the medicine.

[0060] Third consultation: July 2, 2023. All symptoms were relieved, and perineal pain was relieved. The prescription was revised to 6 parts of Ligusticum striatum, 10 parts of Tribulus terrestris, and 10 parts of Lilium brownii.

[0061] Fourth consultation: On July 9, 2023, the perineal pain disappeared and the other symptoms were relieved. The patient was advised to stop medication and observe.

[0062] Example 8 A retrospective clinical observation was conducted on the efficacy and safety of chronic prostatitis / pelvic pain syndrome in 66 patients with symptoms mainly of perineal pain.

[0063] The efficacy evaluation criteria, referencing the efficacy evaluation methods in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)," establish specific evaluation criteria for the treatment of chronic prostatitis / pelvic pain syndrome. Clinical control: Clinical symptoms have basically disappeared, and the ratio of the reduction in NIH-CPSI score to the pre-treatment score (n) is ≥95%.

[0064] Significant effect: Major clinical symptoms disappear significantly, and the ratio of the reduction in NIH-CPSI score to the pre-treatment score (n): 60% ≤ n < 95%.

[0065] Effective: partial disappearance of major clinical symptoms, and the ratio of the reduction in NIH-CPSI score to the pre-treatment score (n): 30% ≤ n < 60%.

[0066] Ineffective: No significant change in main clinical symptoms compared with before treatment, and the ratio of the reduction in NIH-CPSI score to the score before treatment (n): n < 30%.

[0067] Patients were randomly divided into an observation group (n=33) and a control group (n=33). The age, severity of illness, and course of disease were similar between the two groups, making them comparable. The observation group received a decoction prepared from the traditional Chinese medicine composition of this invention for improving perineal pain, one dose daily, 200 mL / dose, decocted in water and taken twice daily, morning and evening. The control group received Qianlieshule capsules (main ingredients: Epimedium, Astragalus, Typhae, Plantago, Achyranthes). After 4 weeks of treatment, the NIH-CPSI scores of patients before and after treatment were compared.

[0068] The overall effective rate in the observation group was 97.0%, while the overall effective rate in the control group was 69.7% (Table 1). Furthermore, after treatment, the safety indicators of blood routine, urine routine, liver and kidney function, and electrocardiogram in the observation group showed no significant changes compared to before treatment, indicating good safety.

[0069] Table 1 Comparison of treatment efficacy in patients with chronic prostatitis / pelvic pain syndrome In summary, the traditional Chinese medicine composition for improving perineal pain of the present invention can fundamentally treat the symptoms of perineal pain, with a high cure rate and no side effects. Furthermore, a follow-up study of patients for 1 to 2 months after treatment showed that the traditional Chinese medicine composition for improving perineal pain of the present invention improved chronic prostatitis / pelvic pain syndrome (with perineal pain as the main symptom), with no recurrence of the condition and stable efficacy.

[0070] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention in any way. Any simple modifications, alterations, and equivalent changes made to the above embodiments based on the inventive essence shall still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for improving perineal pain, characterized in that, It is made of the following raw materials in parts by weight: 6-15 parts of ligusticum, 6-15 parts of tribulus terrestris and 6-15 parts of lily.

2. The traditional Chinese medicine composition for improving perineal pain according to claim 1, characterized in that, It is made of the following raw materials in parts by weight: 10 parts of ligusticum, 10 parts of tribulus terrestris and 10 parts of lily.

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