Actively Recruiting
A Study of Jincaopian Tablets on 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
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 sequelae of pelvic inflammatory disease
- Average pain score (VAS) of 4 or higher in the week before enrollment
- Physical signs score (McCormack scale) between 4 and 12 points at enrollment
- Female aged 18 to 50 years with a history of sexual activity
- Voluntarily agree to participate and sign informed consent form
You will not qualify if you...
- Having an acute pelvic inflammatory disease attack
- Pregnant or breastfeeding, or unwilling to use effective contraception during and 6 months after the trial
- Diagnosed with cervical intraepithelial neoplasia, primary or secondary dysmenorrhea, pelvic stasis syndrome, or chronic pelvic pain from non-pelvic inflammatory causes
- Having specific vaginitis such as vulvovaginal candidiasis, trichomonas vaginitis, or bacterial vaginosis
- Having gynecological tumors (uterine fibroids larger than 3 cm or submucosal fibroids), endometriosis, adenomyosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis, or related symptoms
- Had intrauterine device placement within the past 3 months; absence of uterus and both adnexa
- Received related treatments or similar drugs within 14 days before enrollment
- Liver function with ALT or AST above 1.5 times the normal upper limit; kidney function with serum creatinine above normal upper limit
- Serum CA125 or erythrocyte sedimentation rate above 1.1 times the normal upper limit
- Having serious cardiovascular, cerebrovascular, hematopoietic, or other serious diseases
- Allergy to the experimental drug
- History of long-term alcoholism or drug abuse
- Intellectual disabilities or mental disorders
- Participated in other clinical trials within the last 3 months
- Investigator judges unsuitability for participation
AI-Screening
AI-Powered Screening
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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
CONTACT
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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