Clinical trial NCT05460546: The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pelvic Pain
Lead sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: Baseline to 16 weeks
measure: Modified McCormick Scale
timeFrame: Baseline and at Weeks 4, 8, 12, 16
measure: SF-12 Score
timeFrame: Baseline and at Weeks 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Xiuxiang Teng
role: PRINCIPAL_INVESTIGATOR
References: