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Clinical trial on the treatment of varicocele by Tengxi formula (Essence chamber stasis-heat syndrome)

Clinical trial on the treatment of varicocele by Tengxi formula (Essence chamber stasis-heat syndrome)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001954
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

varicocele

Interventions

observation group:Tengxi formula
control group:Aescuven forte

Sponsors

xiyuan hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meet the Western medical diagnostic criteria for VC; (2) Meet the Chinese medicine diagnostic criteria of essence chamber stasis and heat syndrome; (3) The patient's age is between 18 and 60 years old; (4) Those who have not had VC surgery; (5) Voluntarily participated in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Secondary varicocele, including those caused by nutcracker syndrome, compression by abdominal or retroperitoneal tumors, etc.; (2) Patients with inflammation, tuberculosis or tumors in accessory gonads such as the prostate, epididymis, and testicles; (3) Diseases such as testicular hydrocele and filarial spermatic cord lymphangitis; (4) Acute or chronic scrotal eczema, with symptoms such as redness, swelling, blisters, exudation, and local lichenification of the scrotal skin; (5) Patients with severe primary diseases, including but not limited to severe diarrhea, uncontrolled cardiovascular and cerebrovascular diseases (such as unstable angina pectoris, severe arrhythmia, acute stroke, etc.), decompensated liver disease (ALT/AST > 1.5 times the upper limit of normal), severe renal insufficiency (serum creatinine > upper limit of normal), uncontrolled malignant tumors, active immune system diseases, hematological system diseases (such as severe anemia, coagulation disorders), and other diseases that the observer deems may affect the safety of observation; (6) Patients with severe mental and psychological diseases (such as schizophrenia, severe depression, anxiety disorder, etc.) that are not effectively controlled, or those who need to take drugs that may affect the accuracy of autonomous symptom reporting for a long time (such as potent sedatives); (7) Patients with oligozoospermia or asthenozoospermia, or those who have plans to prepare for pregnancy within the past 3 months; (8) Having participated in other clinical trials or used drugs that affect VC or coagulation function within the past 3 months; (9) Patients who are currently taking Aescuven forte regularly due to other concurrent diseases, or those who have used Aescuven forte within the past 1 month; (10) Patients with allergic constitution, a history of allergy to the ingredients of this product, or those who cannot tolerate the drug.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale score;

Secondary

MeasureTime frame
spermatic vein diameter;duration of reflux;Traditional Chinese Medicine syndrome score;

Countries

China

Contacts

Public ContactFu Wang

xiyuan hospital of China Academy of Chinese Medical Sciences

fu311306@163.com13426071953

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026