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

NCT ID: NCT05460546

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2021-11-30

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.

Conditions

Chronic Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Jincaopian Tablets high-dose group

Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks.

Group Type: EXPERIMENTAL

Jincaopian Tablets high dose

Intervention Type: DRUG

Jincaopian Tablets 0.2g tid p.o.

Jincaopian Tablets low-dose group

Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks.

Group Type: EXPERIMENTAL

Jincaopian Tablets low dose

Intervention Type: DRUG

Jincaopian Tablets 0.1g tid p.o.

Placebo group

Patients receive a matching placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo tid p.o.

Interventions

Jincaopian Tablets high dose

Jincaopian Tablets 0.2g tid p.o.

Intervention Type: DRUG

Jincaopian Tablets low dose

Jincaopian Tablets 0.1g tid p.o.

Intervention Type: DRUG

Placebo

Placebo tid p.o.

Intervention Type: OTHER

Other Intervention Names

ZY5301; ZY5301

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Konruns Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiuxiang Teng

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital of Traditional Chinese Medicine

Locations

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

Teng X, Li H, Yang D, Gao Z, Cui L, Chen H, Song Q, Xu L, Li H, Zhang Q, Wu J, Leng J. ZY5301 Tablet vs Placebo for Treatment of Chronic Pelvic Pain After Pelvic Inflammatory Disease: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2423229. doi: 10.1001/jamanetworkopen.2024.23229.

Reference Type: DERIVED

PMID: 39042407 (View on PubMed)

Other Identifiers

Z-JCP-T-II-2020-HMZC-01

Identifier Type: -

Identifier Source: org_study_id