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

• Status: Completed
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

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.