Treatment of chronic pelvic pain with Jincaopian Tablets

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

This study is testing whether Jincaopian Tablets can help people with chronic pelvic pain from pelvic inflammatory disease feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 414 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05970783 on ClinicalTrials.gov

What this trial studies

This phase III trial aims to evaluate the efficacy and safety of Jincaopian Tablets for treating chronic pelvic pain resulting from pelvic inflammatory disease. The study involves a multicenter, randomized, double-blind, placebo-controlled design with 414 participants, who are assigned to either the Jincaopian Tablets group or a placebo group in a 2:1 ratio. Participants will undergo a 12-week treatment period followed by a 4-week follow-up to assess outcomes related to pain relief and overall well-being.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 50 with chronic pelvic pain due to pelvic inflammatory disease and a pain score of 4 or higher.

Not a fit: Patients with acute pelvic inflammatory disease or chronic pelvic pain from other causes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate chronic pelvic pain for women affected by pelvic inflammatory disease.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in treating chronic pelvic pain, but the specific use of Jincaopian Tablets is novel.

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 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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xiuxiang Teng — Beijing Hospital of Traditional Chinese Medicine
• Study coordinator: Xiuxiang Teng

Conditions: Chronic Pelvic Pain