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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pelvic Pain
• Intervention / Treatment: Drug: Jincaopian Tablets high dose; Drug: Jincaopian Tablets low dose; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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 55 (including 18 and 55) with a history of sexual life;
• Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.

Exclusion Criteria:

• Pelvic inflammatory disease (acute attack);
• Pregnant or lactating women, women of childbearing age who are unwilling to take effective measures to prevent pregnancy during the trial and within 3 months after the trial;
• Critically ill or with surgical indications;
• Previously diagnosed with cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic stasis syndrome and chronic pelvic pain caused by other non-pelvic inflammatory diseases;
• Complicated with specific vaginitis such as vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, etc.;
• Gynecological tumors (maximum diameter of uterine fibroids greater than 3cm and submucosal fibroids), endometriosis, adenomyosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis and other diseases related symptoms;
• Placement of intrauterine device in the past 3 months; absence of uterus and bilateral appendages;
• Received related treatment or took drugs with similar functions and indications within 14 days before the introduction;
• Have a history of allergy to the components of the test drug;
• Participated in other clinical trials within the past 3 months;
• The investigator believes that it is not suitable to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jincaopian Tablets high-dose group; Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks.	Drug: Jincaopian Tablets high dose; Jincaopian Tablets 0.2g tid p.o.; Other Names: ZY5301
Experimental: Jincaopian Tablets low-dose group; Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks.	Drug: Jincaopian Tablets low dose; Jincaopian Tablets 0.1g tid p.o.; Other Names: ZY5301
Placebo Comparator: Placebo group; Patients receive a matching placebo for 12 weeks.	Other: Placebo; Placebo tid p.o.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analog Scale (VAS)	To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.	Baseline to 16 weeks
Modified McCormick Scale	To evaluate the total score of the physical sign scale and the scores of each part including abdominal tenderness, rebound tenderness, and gynecological examination compared with the baseline in each group at weeks 4, 8, 12, 16.	Baseline and at Weeks 4, 8, 12, 16
SF-12 Score	To evaluate the health status of the patients compared with the baseline in each group at weeks 12.	Baseline and at Weeks 12

Collaborators and Investigators

• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xiuxiang Teng, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Pain; Neurologic Manifestations; Adnexal Diseases; Pelvic Inflammatory Disease; Pelvic Infection; Pelvic Pain
• Other Study ID Numbers: Z-JCP-T-II-2020-HMZC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No