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

Z-JCP-T-Ⅲ-2021-BJKC-01

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

2022-11-08

2024-02-01

2024-11-01

Recruiting

Early phase I

414

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 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. 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 6 months after the trial; * 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; * 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; * Liver function: ALT or AST\>1.5 times the upper limit of normal value；Renal function：Scr\>1.0 times the upper limit of normal value; * Serum CA125 and erythrocyte sedimentation \> 1.1 times the upper limit of normal value. * Combined with serious cardiovascular, cerebrovascular, hematopoietic system and other serious diseases; * Have an allergic history to the experimental drug; * Have a long history of alcoholism or drug abuse; * Intellectual disabilities or mental disorders; * Participated in other clinical trials within the past 3 months; * The investigator believes that it is not suitable to participate in this clinical trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 414, 'type': 'ESTIMATED'}}

2023-08-01