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This phase II trial attempts to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease.
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-blind, dose-parallel, placebo-controlled phase II clinical trial is designed to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease. In this trial, 180 subjects were enrolled and randomized to either "high-dose Jincaopian Tablets" group, "low-dose Jincaopian Tablets " group, or the "placebo" group in a 1:1:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks. The outcome measures of chronic pelvic pain relief in this trial are pain visual analog scale (VAS), modified McCormick scale and SF-12 Score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jincaopian Tablets high-dose group | Experimental | Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks. |
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| Jincaopian Tablets low-dose group | Experimental | Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks. |
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| Placebo group | Placebo Comparator | Patients receive a matching placebo for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jincaopian Tablets high dose | Drug | Jincaopian Tablets 0.2g tid p.o. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale (VAS) | To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily. | Baseline to 16 weeks |
| Modified McCormick Scale | To evaluate the total score of the physical sign scale and the scores of each part including abdominal tenderness, rebound tenderness, and gynecological examination compared with the baseline in each group at weeks 4, 8, 12, 16. | Baseline and at Weeks 4, 8, 12, 16 |
| SF-12 Score | To evaluate the health status of the patients compared with the baseline in each group at weeks 12. | Baseline and at Weeks 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiuxiang Teng | Beijing Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39042407 | Derived | Teng X, Li H, Yang D, Gao Z, Cui L, Chen H, Song Q, Xu L, Li H, Zhang Q, Wu J, Leng J. ZY5301 Tablet vs Placebo for Treatment of Chronic Pelvic Pain After Pelvic Inflammatory Disease: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2423229. doi: 10.1001/jamanetworkopen.2024.23229. |
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| Jincaopian Tablets low dose | Drug | Jincaopian Tablets 0.1g tid p.o. |
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| Placebo | Other | Placebo tid p.o. |
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