Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Drug: Sanjie analgesic capsule
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects have a diagnosis of endometriosis by laparoscopy within 5 years prior to signing ICF, main complain of dysmenorrhea (or menstrual pain or painful periods) and with VAS score of 4 or above; Endometriosis combined with uterine adenomyosis is included. Female between the ages of 18 and 45 years old; Regular menstrual period, menstrual cycle falls in the ranging from 28 to 30 days; No pregnancy planning during taking study medication; use (or have their partner use) an acceptable method of birth control within the projected duration of the study ; Subjects must sign ICF and agree for follow up. Exclusion Criteria: Genital cancer or other malignant tumor; Adnexal masses≥5cm; Uterine myoma≥3cm; Suffering from cardiovascular, hepatic, renal or hematopoietic system disease or mental illness; Receiving hormone therapy within 3 months prior to signing ICF; Receiving surgical treatment for endometriosis within 3 months prior to signing ICF; Subjects have a plan of pregnancy, being pregnant, breast-feeding during recent 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sanjie analgesic capsule<br>every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. | Drug: Sanjie analgesic capsule<br>* 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.<br>* Other names: Jiangsu Kanion Pharmaceutical Co.,Ltd;|
| Placebo Comparator: placebo<br>every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. | Drug: placebo<br>* 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.<br>* Other names: Jiangsu Kanion Pharmaceutical Co.,Ltd;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dysmenorrhea |  | Baseline, 1,2,3,4 menstrual cycle | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, dysmenorrhea, Sanjie analgesic capsule, effect/safety