NCT05970783

A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease

A Multicenter, Randomized, Double-blind, Dose-parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Jincaopian Tablets in Subjects with Chronic Pelvic Pain After Pelvic Inflammatory Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this phase III trial to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease

Detailed description

Chronic pelvic pain is the major sequela of pelvic inflammatory disease and it's a common, burdensome, and costly condition that disproportionately affects women. This multicenter, randomized, double-blind, dose-parallel, placebo-controlled phase III clinical trial is designed to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease. In this trial, 414 subjects were enrolled and randomized to either "Jincaopian Tablets" group, or the "placebo" group in a 2:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks.

Conditions

• Chronic Pelvic Pain

Interventions

Type	Name	Description
DRUG	Jincaopian Tablets	Jincaopian Tablets 0.2g tid p.o.
OTHER	Placebo	Placebo 0.2g tid p.o.

Timeline

• Start date: 2022-11-08
• Primary completion: 2024-03-11
• Completion: 2025-04-01
• First posted: 2023-08-01
• Last updated: 2024-10-17

Locations

1 site across 1 country: China