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

Phase 2

Completed

• Conditions: Chronic Pelvic Pain
• Interventions: Drug: Jincaopian Tablets low dose; Other: Placebo; Drug: Jincaopian Tablets high dose

• Registration Number: NCT05460546
• Lead Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2021-01-19
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-13
• Last Update Submitted: 2022-07-13
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jincaopian Tablets low-dose group	Jincaopian Tablets low dose	Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks.
Placebo group	Placebo	Patients receive a matching placebo for 12 weeks.
Jincaopian Tablets high-dose group	Jincaopian Tablets high dose	Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Modified McCormick Scale	Baseline and at Weeks 4, 8, 12, 16	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.
SF-12 Score	Baseline and at Weeks 12	To evaluate the health status of the patients compared with the baseline in each group at weeks 12.
Pain Visual Analog Scale (VAS)	Baseline to 16 weeks	To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.

Trial Locations

Locations (1)

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China