A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease (NCT05970783) | Clinical Trial Compass
RecruitingPhase 3
A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
China414 participantsStarted 2022-11-08
Plain-language summary
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
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
Pain disappearance rate after 12 weeks of treatment