NCT02031523

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Sanjie analgesic capsule	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.
DRUG	placebo	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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2014-01-09
• Last updated: 2014-11-19

Locations

14 sites across 1 country: China