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| Name | Class |
|---|---|
| Beijing Bionovo Medicine Development Co., Ltd. | OTHER |
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It is a multi-center, double -blind, placebo -controlled, randomized post-marketing study in Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.
Sanjie Analgesic Capsule is a Chinese Traditional Patent Medicine. It is a botanical extract from the raw materials of the Resina Draconis , Panax Notoginseng, fritillary bulb and coix seed, which are derived from a classic prescription of traditional Chinese medicine.
Sanjie Analgesic Capsule was approved by CFDA in 2004, produced by means of modern technology by Jiangsu Kanion Pharmaceutical Co., Ltd. The study is a multi-center, double -blind, placebo-controlled, randomized in Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sanjie analgesic capsule | Active Comparator | every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. |
|
| placebo | Placebo Comparator | every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sanjie analgesic capsule | Drug | Oral, four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.or follow the doctor's advice. |
| Measure | Description | Time Frame |
|---|---|---|
| dysmenorrhea | Baseline, 1,2,3,4 menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge ) | baseline,1,2,3,4 menstrual cycle | |
| change of Signs(Pelvic-tenderness Tubercle ) | baseline,1,2,3,4 menstrual cycle | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lang Jinghe, Doctor | Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing ChaoYang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39046647 | Derived | Leng JH, Duan H, Guan Z, Zhou YF, Qu H, Xu KH, Zhang SF, Zhang Q, Wang X, Lin KQ, Lang JH. Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain: A Multicenter, 3:1 Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2024 Sep;30(9):780-787. doi: 10.1007/s11655-024-3756-y. Epub 2024 Jul 24. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| placebo | Drug | oral,four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Or Follow the doctor's advice. |
|
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| change of Menstrual cycle and quantity |
| baseline,1,2,3,4 menstrual cycle |
| change of serum CA125 | baseline,3,4 menstrual cycle |
| the size of uterus and endometriosis cyst | baseline,3,4 menstrual cycle |
| change of serum endocrinological hormone | the content of FSH, LH, E2, PRL, P, T | baseline,3,4 menstrual cycle |
| change of SF-36 score | Baseline,3 menstrual cycle |
| Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests | Baseline,3 menstrual cycle |
| Safety assessments will be based on adverse event reports | 1,2,3 menstrual cycle |
| Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100026 | China |
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| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| The General Hospital of People's Liberation Army | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Hubei Provincal Hospital of TCM | Recruiting | Wuhan | Hubei | 430061 | China |
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| The First Hospital of Hunan University of chinese Medicine | Recruiting | Changsha | Hunan | 410000 | China |
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| The Maternal and Child Health Hospital of Hunan Province | Recruiting | Changsha | Hunan | 41008 | China |
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| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110004 | China |
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| Jinan municipal hospital of Traditional Chinese Medicine | Recruiting | Jinan | Shandong | 250012 | China |
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| The Second Hospital of Shandong University of Traditional Chinese Medicine | Recruiting | Jinan | Shandong | 25001 | China |
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| Obstetrics and Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| Women's Hospital School Of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| Guangxing Hospital Of Zhejiang Chinese Medicine University | Recruiting | Hangzhou | Zhejiang | 31007 | China |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |