Actively Recruiting
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
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-10-17
414
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Jincaopian Tablets for treating chronic pelvic pain in women who have had pelvic inflammatory disease. This phase III clinical trial aims to address the significant burden of chronic pelvic pain, a common complication following pelvic inflammatory disease, by comparing Jincaopian Tablets to a placebo in a well-controlled study environment. Participants are randomly assigned in a 2:1 ratio to receive either Jincaopian Tablets or a placebo. Those in the Jincaopian group take 0.6 grams daily for 12 weeks, while the placebo group receives an identical regimen. After completing the treatment period, all participants enter a 4-week follow-up period to assess ongoing effects. During the study, researchers will monitor pain disappearance rates at 12 weeks as the primary outcome. Secondary measures include pain scores over time, quality of life assessments, and evaluations of physical signs related to pain. Safety is closely monitored through reports of adverse events. Participants will be regularly assessed throughout the 16-week total study duration to understand treatment impact and safety.
CONDITIONS
Brief Title
A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria for chronic pelvic pain after pelvic inflammatory disease
- Average pain score of at least 4 on the Visual Analogue Scale (VAS) during the week before enrollment
- McCormick scale score between 4 and 12 points at enrollment
- Female aged 18 to 50 years with a history of sexual activity
- Voluntarily agree to participate and provide informed consent
You will not qualify if you...
- Current acute pelvic inflammatory disease
- Pregnant or breastfeeding women, or women unwilling to use contraception during the study and for 6 months after
- Diagnosed with cervical intraepithelial neoplasia, dysmenorrhea, pelvic stasis syndrome, or chronic pelvic pain from other causes
- Specific vaginal infections like candidiasis, trichomonas, or bacterial vaginosis
- Gynecological tumors (uterine fibroids over 3cm), endometriosis, adenomyosis, cervicitis, tuberculosis-related pelvic inflammatory disease, interstitial cystitis, or related symptoms
- Intrauterine device placed within the past 3 months; absence of uterus and both appendages
- Treatment with similar drugs within 14 days before enrollment
- Liver or kidney function tests exceeding 1.5 times normal limits
- Elevated serum CA125 or erythrocyte sedimentation rate above normal limits
- Serious cardiovascular, cerebrovascular, blood, or other severe diseases
- Allergy to the study drug
- History of alcoholism or drug abuse
- Intellectual disabilities or mental disorders
- Participation in other clinical trials within past 3 months
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive Jincaopian Tablets or placebo to treat chronic pelvic pain after pelvic inflammatory disease.
Regular visits during the 12-week treatment period
Duration - 4 weeks
Participants are monitored for safety and efficacy after completing treatment.
1 follow-up visit after treatment
Trial Site Locations
Total: 1 location
1
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xiuxiang Teng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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