NCT05460546

The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial attempts 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 II 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, 180 subjects were enrolled and randomized to either "high-dose Jincaopian Tablets" group, "low-dose Jincaopian Tablets " group, or the "placebo" group in a 1:1:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks. The outcome measures of chronic pelvic pain relief in this trial are pain visual analog scale (VAS), modified McCormick scale and SF-12 Score.

Conditions

• Chronic Pelvic Pain

Interventions

Type	Name	Description
DRUG	Jincaopian Tablets high dose	Jincaopian Tablets 0.2g tid p.o.
DRUG	Jincaopian Tablets low dose	Jincaopian Tablets 0.1g tid p.o.
OTHER	Placebo	Placebo tid p.o.

Timeline

• Start date: 2021-01-19
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2022-07-15
• Last updated: 2022-07-15

Locations

1 site across 1 country: China