Traditional Chinese medicine composition and application thereof in treating varicocele

Abstract

The invention relates to a traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-40 parts of honeysuckle stem, 10-20 parts of radix cyathulae, 10-20 parts of fructus liquidambaris and 4.5-13.5 parts of semen aesculi. The traditional Chinese medicine composition does not contain toxic medicinal materials, has good tolerance after long-term use, and is suitable for long-term conditioning of varicocele patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and more particularly to a traditional Chinese medicine composition and its use in treating varicocele. Background Technology

[0002] Varicocele (VC) is a common male reproductive system disease, with a prevalence of 15%-20% in the general male population and as high as 30%-81% in infertile men. This disease can cause scrotal pain and discomfort, decreased testicular function, and abnormal semen parameters. Approximately 2% to 10% of patients experience pain or discomfort in the scrotum and its contents. Traditional Chinese medicine considers varicocele to be primarily a blood stasis syndrome, where stagnant blood accumulates in the spermatic cord veins, causing blockage and tortuosity of the meridians, resulting in the pathological characteristic of "blood stasis leading to tortuous and dilated veins." This further evolves from "blood stasis in the veins," eventually generating heat and dampness. Therefore, symptoms of heat stagnation in the seminal vesicles may be observed: scrotal and groin pain, accompanied by a feeling of heaviness, scrotal dampness, painful ejaculation, and dark or scanty yellow urine. On the other hand, existing prescriptions for treating varicocele contain hepatotoxic herbs; long-term use may lead to nausea, vomiting, and liver damage, and is especially contraindicated in patients with liver dysfunction. Secondly, existing prescriptions for treating varicocele are not sufficiently targeted at symptoms such as scrotal swelling and pain, groin pain, and scrotal dampness, resulting in a low rate of symptom improvement. Thirdly, existing prescriptions for treating varicocele mainly focus on promoting blood circulation and removing blood stasis, which has the drawback of simply promoting blood circulation and depleting qi, making them unsuitable for patients with varicocele exhibiting a mixture of deficiency and excess. Summary of the Invention

[0003] The first aspect of this invention provides a traditional Chinese medicine composition for treating varicocele that does not contain toxic ingredients. It has good long-term tolerability and is suitable for long-term conditioning of patients with varicocele. The raw materials for preparing the traditional Chinese medicine composition include 20-40 parts by weight of honeysuckle vine, 10-20 parts by weight of Achyranthes bidentata, 10-20 parts by weight of Liquidambar formosana, 4.5-13.5 parts by weight of Spatholobus suberectus, 10-20 parts by weight of Paeonia lactiflora, and 5-15 parts by weight of Glycyrrhiza uralensis.

[0004] Furthermore, in a second aspect, the present invention provides a traditional Chinese medicine composition in which the weight ratio of the *Lysimachia christinae* to the *Salvia splendens* is 14-16:8-10, which is more targeted at symptoms such as scrotal dampness, scrotal swelling and pain, and groin pain.

[0005] Furthermore, in a third aspect, the present invention provides a traditional Chinese medicine composition in which the weight ratio of the white peony root and the raw licorice root is 14-16:9-11, which overcomes the drawback of formulas that are mainly for promoting blood circulation and removing blood stasis, which simply promote blood circulation and deplete qi. At least one beneficial effect of the present invention is that the traditional Chinese medicine composition of the present invention does not contain toxic medicinal materials, has good long-term tolerance, and is suitable for long-term conditioning of patients with varicocele. Attached Figure Description Figure 1 : Facial expression pain rating scale. Detailed Implementation

[0006] In the embodiments of the present invention, the medicinal materials' origin, Latin name, medicinal part, properties, meridian tropism, and efficacy are as follows:

[0007] Honeysuckle vine is the dried stem and branches of Lonicera japonica Thunb., a plant in the Caprifoliaceae family. It is harvested in autumn and winter and then dried in the sun.

[0008] The dried root of Cyathula officinalis Kuan, a plant in the Amaranthaceae family, is called Sichuan Achyranthes bidentata. It is harvested in autumn and winter, and the rhizome, fibrous roots, and mud are removed. It is then dried by baking or sun-drying until semi-dry, piled up to rehydrate, and then dried by baking or sun-drying again.

[0009] Lulutong is the dried, mature inflorescence of *Liquidambar formosana* Hance, a plant in the Hamamelidaceae family. The fruit is harvested in winter after ripening, impurities are removed, and the fruit is dried.

[0010] The product, *Aesculus chinensis* seeds, refers to the dried, mature seeds of *Aesculus chinensis* Bge., *Aesculus chinensis* Bge. var. *chekiangensis* (Hu et Fang) Fang, or *Aesculus wilsonii* Rehd., all belonging to the Aesculaceae family. The seeds are harvested in autumn when the fruit is ripe, the pericarp is removed, and the seeds are sun-dried or dried at low temperature.

[0011] White peony root is the dried root of Paeonia lactiflora Pall., a plant in the Ranunculaceae family. It is harvested in summer and autumn, washed, and the head, tail, and fine roots are removed. It is then boiled in boiling water to remove the outer skin, or the skin is removed before boiling, and finally dried in the sun.

[0012] Raw licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all belonging to the legume family. It is harvested in spring and autumn, the fibrous roots are removed, and it is then sun-dried.

[0013] In the embodiments of the present invention, the traditional Chinese medicine compositions were all prepared into decoctions and then clinically tested. The following methods for preparing the decoctions should not be regarded as specific limitations on the scope of protection of the present invention:

[0014] To prepare the decoction, take the prescribed amount of Chinese medicinal herbs, soak them in water for 30-60 minutes, bring to a boil over high heat, then simmer over low heat for 25-40 minutes. Filter to obtain the first decoction. Add water to the dregs again, simmer over low heat for 20-30 minutes, and filter to obtain the second decoction. Combine the two filtrates and concentrate to the specified density to obtain the decoction.

[0015] Example 1. Non-toxic traditional Chinese medicine composition

[0016] Toxic Chinese herbal medicines are classified into highly toxic, toxic, and slightly toxic categories. A course of treatment with a traditional Chinese medicine formula for varicocele typically requires four weeks. These formulas often include slightly toxic herbs, and long-term use may cause adverse reactions such as nausea, vomiting, and liver damage. Therefore, it is necessary to provide a traditional Chinese medicine composition for treating varicocele that does not contain toxic ingredients, ensuring good long-term tolerability and suitability for long-term treatment of varicocele patients. In some embodiments, this invention provides a traditional Chinese medicine composition, the raw materials for preparing the composition including 20-40 parts by weight of Lonicera japonica vine, 10-20 parts by weight of Achyranthes bidentata root, 10-20 parts by weight of Liquidambar formosana fruit, 4.5-13.5 parts by weight of Salvia miltiorrhiza fruit, 10-20 parts by weight of Paeonia lactiflora root, and 5-15 parts by weight of Glycyrrhiza uralensis root.

[0017] In this formula (Tengxi Formula), honeysuckle vine enters the collaterals to clear heat, unblock the meridians, and relieve pain; Sichuan achyranthes root invigorates blood, unblocks the meridians, removes blood stasis, and relieves pain. Together they serve as the principal ingredients to achieve the effects of invigorating blood, unblocking the collaterals, clearing heat, and relieving pain; Liquidambar formosana removes dampness, unblocks the collaterals, and relieves muscle and tendon pain. The Compendium of Materia Medica states that "its nature is great in unblocking the twelve meridians and acupoints." It is used to stop yin sweating and, together with honeysuckle vine, enhances the "unblocking of collaterals" effect; white peony root enters the liver meridian and is good at unblocking blood vessels, relieving spasms and pain. Together with Liquidambar formosana, it serves as the assistant ingredient; Salvia miltiorrhiza seed is added to regulate qi, relieve pain, and promote blood circulation. The seeds contain aescin compounds, which have anti-inflammatory, anti-edema, and microcirculation-improving effects; licorice clears heat, detoxifies, harmonizes the middle jiao, and relieves spasms. Together with white peony root, it has the effect of "softening tendons and relieving pain" and can also harmonize the effects of other herbs; Sichuan achyranthes root guides the other herbs in the formula downwards, entering the spermatic cord and collaterals to clear heat, remove blood stasis, and relieve pain. Overall, the combination of herbs in the formula is reasonable.

[0018] Clinical research conducted by Xiyuan Hospital of China Academy of Chinese Medical Sciences (using the same experimental methods as the case described below) showed that the total effective rate of this Chinese medicine composition was 94.44%, and no adverse reactions such as nausea, vomiting, or liver damage were observed in any patient throughout the entire treatment course.

[0019] In traditional Chinese medicine diagnosis and treatment, if the patient has other symptoms or discomfort, such as thin semen, soreness and weakness of the lower back and knees, add 15g of wolfberry, 15g of schisandra, and 10g of cornus officinalis (all kidney-tonifying herbs) to the herbal composition in this application. If there is scrotal itching, add 15g of cnidium monnieri (a wind-dispelling and itch-relieving herb). If there is scrotal cold pain, aversion to cold and cold limbs, add 6g of fennel and 10g of lindera (a liver-soothing and yang-tonifying herb). If there is cloudy urine and dribbling, add 15g of dioscorea hypoglauca and 12g of plantain seed (a diuretic, urinary tract clearing, and turbidity-resolving herb).

[0020] Example 2. A traditional Chinese medicine composition that simultaneously regulates Qi and blood.

[0021] Existing traditional Chinese medicine formulas for treating varicocele mostly focus on promoting blood circulation and removing blood stasis. However, improper regulation of qi and blood can lead to the drawback of simply promoting blood circulation and depleting qi. In some embodiments, based on Example 1, these herbal compositions incorporate white peony root and raw licorice root in a weight ratio of 14-16:9-11. This further enhances the blood-nourishing and liver-soothing effects of white peony root and the harmonizing effects of raw licorice root, achieving a balance between qi and blood regulation and avoiding the drawback of simply promoting blood circulation and depleting qi. This approach is suitable for patients with varicocele exhibiting a mixture of deficiency and excess patterns. Clinical research at Xiyuan Hospital of the China Academy of Chinese Medical Sciences (using the same experimental methods as the examples described below) showed that the overall symptom improvement rate of this herbal composition was 95.56%.

[0022] Example 3. Targeted Traditional Chinese Medicine Composition for Scrotal Dampness, Scrotal Swelling and Pain

[0023] Varicocele patients often present with blood stasis syndrome, where stagnant blood accumulates in the spermatic cord veins, causing blockage and tortuosity of the meridians, forming the pathological characteristic of "blood stasis leading to tortuous and dilated veins." This further evolves from "blood stasis in the veins," eventually generating heat and dampness. Therefore, symptoms of heat stasis in the seminal vesicles can be observed, such as scrotal or groin pain, accompanied by a feeling of heaviness, scrotal dampness, painful ejaculation, and dark, scanty, or yellow urine. Existing Chinese herbal formulas are insufficiently targeted at symptoms such as scrotal dampness. In some embodiments, based on Example 1, these herbal compositions can treat patients with varicocele exhibiting heat stasis in the seminal vesicles. The addition of *Luffa cylindrica* and *Salvia miltiorrhiza* in a weight ratio of 14–16:8–10 better suits the syndrome characteristics, especially excelling at improving local symptoms such as scrotal dampness and distending pain. Clinical research conducted by Xiyuan Hospital of China Academy of Chinese Medical Sciences (using the same experimental methods as the experimental cases described below) showed that the Chinese herbal composition improved scrotal swelling and pain symptoms by 97.78%, groin pain symptoms by 98.89%, and scrotal dampness symptoms by a significant amount.

[0024] Example 4. Traditional Chinese Medicine Composition - Basic Formula

[0025] The traditional Chinese medicine composition of this application is an empirical formula obtained by the Department of Andrology of Xiyuan Hospital of China Academy of Chinese Medical Sciences for the treatment of varicocele (VC). It has been used clinically for several years and has the effects of clearing heat and promoting blood circulation, unblocking collaterals and relieving pain. In some specific embodiments, the composition includes 30g of honeysuckle vine, 15g of Achyranthes bidentata, 15g of Liquidambar formosana, 9g of Salvia miltiorrhiza, 15g of Paeonia lactiflora, and 10g of Glycyrrhiza uralensis.

[0026] The traditional Chinese medicine composition described in this application is an experienced formula for treating VC (vital energy deficiency) at the Department of Andrology of Xiyuan Hospital. It has been applied to thousands of VC patients annually, significantly improving symptoms such as scrotal swelling and pain, groin pain, and scrotal dampness, while also improving semen quality. Clinical studies have shown a total effective rate of 94.45% and a total symptom improvement rate of 95.56%, with an improvement rate of 97.78% for scrotal swelling and pain and 98.89% for groin pain.

[0027] Trial Case Clinical Trial

[0028] Experimental Methods: The relevant data used for screening the following experimental cases are as follows:

[0029] 1. Diagnostic criteria for varicocele:

[0030] (1) The diagnosis is mainly based on the criteria proposed in the "Guidelines for the Diagnosis and Treatment of Varicocele (2022)": color Doppler ultrasound is the preferred detection method. The patient is examined in both supine and standing positions. The diameter of the spermatic vein (DR) is routinely measured, and the presence and duration of venous reflux (TR) are observed. According to the ultrasound diagnosis, varicocele can be divided into clinical and subclinical types:

[0031] ① Subclinical varicocele: Clinical palpation is negative, but the maximum internal diameter is 1.8~2.1mm on ultrasound examination during quiet breathing, but there is no reflux. Reflux occurs during Valsalva maneuver, and the reflux time is 1~2s.

[0032] ② Clinical varicocele grade I: positive on clinical palpation and maximum internal diameter of 2.2~2.7mm on ultrasound examination during quiet breathing; reflux is present during Valsalva maneuver, with reflux duration of 2~4 seconds;

[0033] ③ Clinical varicocele grade II: positive on clinical palpation and maximum internal diameter of 2.8~3.1mm on ultrasound examination during quiet breathing; reflux is present during Valsalva maneuver, with a reflux time of 4~6s.

[0034] ④ Clinical varicocele grade III: positive on clinical palpation and maximum internal diameter ≥3.1mm on ultrasound examination during quiet breathing, with reflux during Valsalva maneuver and reflux time ≥6s.

[0035] (2) The diagnosis is mainly based on the criteria proposed in the "Guidelines for the Diagnosis and Treatment of Varicocele (2022)": According to the patient's complaints of persistent or intermittent local distending discomfort, dull pain and aching pain in the affected scrotum and its contents (testis, spermatic cord), as well as increased temperature, the pain is aggravated by prolonged standing, exercise and fatigue, and relieved by waking up in the morning, lying down and resting, and lifting the scrotum. The pain is classified into three categories: mild, moderate and severe according to the pain severity grading method.

[0036] ① Mild pain: There is pain, but it is tolerable. Daily life is normal and sleep is not disturbed;

[0037] ② Moderate pain: The pain is obvious and unbearable, requiring the use of analgesics, and sleep is disturbed;

[0038] ③ Severe pain: The pain is intense and unbearable, requiring analgesics. Sleep is severely disrupted, and it may be accompanied by autonomic dysfunction or passive posture.

[0039] For patients with language, cultural differences and other communication barriers, the numerical rating method and facial expression pain rating scale in the "Guidelines for the Diagnosis and Treatment of Varicocele (2022)" can be used to assess pain levels.

[0040] Numerical rating scale: Pain intensity is represented by numbers from 0 to 10, where 0 represents no pain and 10 represents the most intense pain imaginable. Patients choose the number that best represents their pain level, or medical staff assist them in choosing a number to describe their pain. Based on the numerical rating, pain intensity is categorized as: ① Mild pain (1-3); ② Moderate pain (4-6); ③ Severe pain (7-10).

[0041] Facial Expression Pain Rating Scale (FARS), see [link / reference]. Figure 1 .

[0042] 2. Test methods:

[0043] To increase the reliability of the trial, in addition to adopting the above diagnostic criteria, the subjects should have given their consent, and based on factors such as medical history, lifestyle habits, medication habits, and routine medical tests to rule out other congenital diseases, infectious diseases, drug allergies, poor compliance, and force majeure, 180 subjects aged 30-40 years who met the Western medicine diagnostic criteria for varicocele were selected and randomly divided into two groups: a treatment group and a control group. The treatment group was treated with the traditional Chinese medicine composition of this application, while the control group was treated with Guizhi Fuling Wan.

[0044] 3. Treatment plan:

[0045] The treatment group was treated with the herbal composition of the present invention. After soaking in water for 30-60 minutes, the mixture was brought to a boil over high heat, then simmered over low heat for 25-40 minutes. The first decoction was then filtered. The dregs were added to water again and simmered over low heat for 20-30 minutes. The second decoction was then filtered. The two filtrates were combined and concentrated to the specified density to obtain the decoction.

[0046] 4. Evaluation of treatment effectiveness:

[0047] Main effect indicators: (1) Traditional Chinese medicine syndrome scoring table, (2) color Doppler ultrasound detection, (3) grade of the degree of scrotal swelling and pain, (4) grade of the degree of groin pain.

[0048] (1) See Table 1 for the TCM syndrome scoring table:

[0049] Table 1. Traditional Chinese Medicine Syndrome Scoring Table

[0050]

[0051] (2) Color Doppler ultrasound detection

[0052] Subclinical type: DR 1.8~2.1mm, TR 1~2s; Grade I: DR 2.2~2.7mm, TR 2~4s; Grade II: DR 2.8~3.1mm, TR 4~6s; Grade III: DR≧3.1mm, TR≧6s.

[0053] (3) Pain level rating

[0054] ① Mild pain: There is pain, but it is tolerable. Daily life is normal and sleep is not disturbed;

[0055] ② Moderate pain: The pain is obvious and unbearable, requiring the use of analgesics, and sleep is disturbed;

[0056] ③ Severe pain: The pain is intense and unbearable, requiring analgesics. Sleep is severely disrupted, and it may be accompanied by autonomic dysfunction or passive posture.

[0057] 5. Overall efficacy evaluation criteria

[0058] Significant effect: Varicocele improved by grade II or above or reached normal, the chief complaint of scrotal swelling and pain disappeared, and there was no scrotal dampness;

[0059] Effective: The chief complaint of scrotal swelling and pain was significantly reduced, scrotal dampness was improved, and varicocele was improved compared to before;

[0060] Ineffective: The chief complaint of scrotal swelling and pain has not improved or has worsened; scrotal dampness has not improved or is accompanied by stickiness, odor, and itching; and the degree of varicocele has not improved or has worsened compared to before.

[0061] 6. Criteria for assessing the degree of symptom improvement

[0062] Significant improvement: Symptoms disappear or essentially disappear, and the proportion of symptom scores reduced by >95%;

[0063] Moderate improvement: 70% < reduction in syndrome score < 95%;

[0064] Mild improvement: 30% ≤ reduction in syndrome score < 70%;

[0065] No improvement: The percentage of reduction in syndrome score is less than 30% or the condition worsens.

[0066] 7. Standards for improvement in the degree of scrotal swelling and pain

[0067] Significant improvement: Pain disappears, or VAS score is below 3;

[0068] Mild improvement: VAS score 4-6;

[0069] No improvement: Pain persists or worsens.

[0070] 8. Standards for improvement in groin pain

[0071] Significant improvement: Pain disappears, or VAS score is below 3;

[0072] Mild improvement: VAS score 4-6;

[0073] No improvement: Pain persists or worsens.

[0074] 9. Evaluation criteria for the degree of improvement in varicocele

[0075] Grade III Improvement: Varicocele severity reduced by two grades or no varicocele;

[0076] Grade II Improvement: Varicocele severity reduced by one grade, but still present;

[0077] Grade I Improvement: Varicocele severity has improved compared to before, but not enough to reduce it by one grade;

[0078] No improvement: Varicocele severity remains unchanged or worsens;

[0079] Table 2 compares the overall efficacy results between the two groups of patients:

[0080] Table 2 Comparison of overall efficacy between the two groups of patients (%)

[0081]

[0082] Table 3 shows a comparison of the degree of symptom improvement before and after treatment in the two groups of patients:

[0083] Table 3 Comparison of symptom improvement before and after treatment in the two groups of patients

[0084]

[0085] Table 4 compares the degree of scrotal swelling and pain before and after treatment in the two groups of patients:

[0086] Table 4 compares the degree of scrotal swelling and pain before and after treatment in the two groups of patients:

[0087]

[0088] Table 5 compares the degree of scrotal dampness before and after treatment in the two groups of patients: Table 5 shows a comparison of the degree of groin pain before and after treatment in the two groups of patients:

[0089]

[0090] Table 6 compares the degree of improvement in varicocele before and after treatment in the two groups of patients:

[0091] Table 6 Comparison of the degree of improvement in varicocele before and after treatment in the two groups of patients.

[0092]

[0093] 10. Typical Cases

[0094] Case 1:

[0095] Patient Information: Mr. Li, male, 35 years old, company employee. Chief complaint: Severe scrotal swelling and pain for 3 months. Present Illness: Severe scrotal swelling and pain, aggravated by prolonged standing or exertion, relieved by rest; significant scrotal dampness; dry mouth; irritability; yellow urine. Red tongue with yellow, greasy coating; wiry, rapid pulse. VAS pain score: 7. Physical Examination: Grade II varicocele on the left side. Traditional Chinese Medicine Diagnosis: Stagnation and heat in the seminal vesicles. Treatment Principle: Clearing heat, promoting blood circulation, unblocking the meridians, and relieving pain. Prescription: The herbal composition described in this application. After 28 days of medication, the scrotal swelling and pain lessened (VAS score decreased to 3), and the scrotal dampness largely subsided. The tongue coating turned thin and white, and the pulse became wiry and even.

[0096] Case 2: Patient Zheng, male, 32 years old, programmer. Chief complaint: Sudden onset of severe left scrotal pain for 2 days after strenuous exercise (VAS score: 9). Scrotal dampness was not obvious, with local redness and swelling. Tongue was red with a yellow coating, and pulse was wiry and rapid. Ultrasound examination showed a left spermatic vein diameter of 2.8 mm, with significant reflux during the Valsalva maneuver, confirming a diagnosis of grade II varicocele. Traditional Chinese medicine diagnosis was seminal vesicle stasis and heat syndrome (qi stagnation and blood stasis, leading to heat). Treatment focused on promoting qi and blood circulation, clearing heat and relieving pain, using the herbal composition described in this application. After one week of medication, the pain significantly decreased (VAS score dropped to 4), and nausea disappeared. Follow-up ultrasound showed no significant changes, but the patient reported improved symptoms.

[0097] Case 3: Patient He, male, 36 years old, administrative staff. Chief complaint: scrotal dampness for 1 year, seeking medical attention for fertility. The dampness was moderate, accompanied by fatigue, weakness, and soreness in the lower back and knees, with no significant left-sided swelling or pain. Semen analysis showed low sperm motility. Tongue was pale red with a thin yellow coating, and pulse was deep and thready. Ultrasound examination showed a left spermatic vein diameter of 2.6 mm, and a short-term reflux was observed during the Valsalva maneuver, confirming a diagnosis of grade I varicocele. Traditional Chinese medicine diagnosis was seminal vesicle stasis and heat syndrome (damp-heat damaging essence, combined with liver and kidney deficiency). Treatment principle: clearing damp-heat, supplemented with tonifying the liver and kidneys. The prescribed Chinese herbal composition combined with kidney-tonifying herbs (15g of wolfberry, 15g of schisandra, and 10g of cornus) was modified. After 3 months of medication, the scrotal dampness symptoms completely disappeared, sperm motility improved, and a follow-up ultrasound showed the disappearance of reflux.

[0098] Case 4: Patient Ma, male, 38 years old, bank employee. Chief complaint: scrotal dampness for 3 months, occasional dry mouth, but also aversion to cold and cold limbs. Moderate dampness, occasional feeling of heaviness. Pale and dark tongue, white and greasy yellow coating, deep and wiry pulse. Ultrasound examination showed a left spermatic vein diameter of 2.8 mm, and persistent reflux was observed during the Valsalva maneuver, confirming a diagnosis of grade II varicocele. Traditional Chinese medicine diagnosis was seminal vesicle stasis and heat syndrome (mixed cold and heat, dampness accumulation). Treatment principle: adjust the balance of cold and heat, clear damp heat, invigorate blood and unblock collaterals. The prescribed Chinese herbal composition was modified (with the addition of a small amount of liver-soothing and yang-tonifying herbs, 6g of fennel and 10g of Lindera strychnifolia). After two courses of treatment, the mixed cold and heat symptoms disappeared, and the scrotal dampness was completely relieved; follow-up ultrasound showed a venous diameter of 2.6 mm and a shortened reflux time.

[0099] Case 5: Patient Zhu, male, 40 years old, designer. Chief complaint: scrotal dampness and itching for 3 months, worsening after prolonged sitting at work. The dampness was moderate, without significant heaviness or pain. Accompanying symptoms included sticky and difficult bowel movements, dry mouth without thirst. Tongue was red with a yellow, greasy coating, and pulse was wiry and rapid. Physical examination revealed grade II varicocele on the left side. Traditional Chinese medicine diagnosis was scrotal heat stagnation syndrome. Treatment principle: clearing heat, promoting diuresis, relieving itching, and invigorating blood circulation. The prescribed Chinese herbal composition was modified (adding wind-dispelling and antipruritic herbs, including 15g of Cnidium monnieri). After two courses of treatment, the scrotal dampness and itching symptoms completely disappeared, and bowel movements improved.

[0100] The above-described embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that: The raw materials for preparing the traditional Chinese medicine composition include 20-40 parts by weight of honeysuckle vine, 10-20 parts by weight of Achyranthes bidentata, 10-20 parts by weight of Liquidambar formosana, 4.5-13.5 parts by weight of Salvia miltiorrhiza, 10-20 parts by weight of Paeonia lactiflora, and 5-15 parts by weight of raw licorice.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The weight ratio of the *Lulu Tong* to the *Saluo Zi* is 14-16:8-10.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The weight ratio of the white peony root to the raw licorice root is 14-16:9-11.

4. The traditional Chinese medicine composition according to claim 3, characterized in that: The raw materials for preparing the traditional Chinese medicine composition include 30 parts by weight of honeysuckle vine, 15 parts by weight of Achyranthes bidentata, 15 parts by weight of Liquidambar formosana, 9 parts by weight of Salvia miltiorrhiza, 15 parts by weight of Paeonia lactiflora, and 10 parts by weight of raw licorice.

5. A pharmaceutical preparation, characterized in that: The pharmaceutical preparation comprises the traditional Chinese medicine composition as described in any one of claims 1 to 4, and excipients.

6. The pharmaceutical preparation according to claim 5, characterized in that: The pharmaceutical preparation is an oral medication; preferably, the pharmaceutical preparation is a decoction.

7. The use of the traditional Chinese medicine composition or pharmaceutical preparation as described in any one of claims 1 to 6 in the preparation of a drug for treating varicocele.

8. The use as described in claim 7, characterized in that, The varicocele is complicated by liver dysfunction or cardiovascular disease.

9. The use as described in claim 7, characterized in that, The varicocele is accompanied by symptoms of scrotal swelling and pain and / or scrotal dampness.

10. The use as described in claim 7, characterized in that, The varicocele described belongs to the syndrome of blood stasis and heat in the seminal vesicle.

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