Status:
RECRUITING
A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
Lead Sponsor:
Beijing Konruns Pharmaceutical Co., Ltd.
Conditions:
Chronic Pelvic Pain
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief 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
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT05970783
Start Date
November 8 2022
End Date
April 1 2025
Last Update
October 17 2024
Active Locations (1)
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1
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing, Beijing Municipality, China