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New treatment option for Chronic Pelvic Pain
Official title A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
ClinicalTrials.gov ID: NCT05970783
What this study is testing
What is Jincaopian Tablets?
Jincaopian Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic pelvic pain.
Also referred to as ZY5301.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- Previously diagnosed with cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic stasis syndrome and chronic pelvic pain caused...
- 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...
- Placement of intrauterine device in the past 3 months; absence of uterus and bilateral appendages;
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.