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
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• Meet the diagnostic criteria for chronic pelvic pain sequelae of pelvic inflammatory disease;
• The average VAS score of pain in the week before enrollment is ≥4;
• The McCormack scale of physical signs at the time of enrollment is 4 to 12 points (including 4 points and 12 points);
• Women aged 18 to 50 (including 18 and 50) with a history of sexual life;
• Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.
Locations
Other Locations
China
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xiuxiang Teng
tengxx@126.com
+86 010-87906734
Time Frame
Start Date: 2022-11-08
Estimated Completion Date: 2025-04
Participants
Target number of participants: 414
Treatments
Experimental: Jincaopian Tablets group
Patients receive Jincaopian Tablets 0.6g/day for 12 weeks.
Placebo_comparator: Placebo group
Patients receive a placebo 0.6g/day for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Beijing Konruns Pharmaceutical Co., Ltd.