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Recruiting NCT05970783

A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease

Phase III Interventional Chronic Pelvic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Jincaopian Tablets, Placebo.
Who it may be relevant to
Registry conditions: Chronic Pelvic Pain. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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-blind, dose-parallel, placebo-controlled phase III 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, 414 subjects were enrolled and randomized to either "Jincaopian Tablets" group, or the "placebo" group in a 2:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks.

Interventions

  • Drug Jincaopian Tablets
    Jincaopian Tablets 0.2g tid p.o.
  • Other Placebo
    Placebo 0.2g tid p.o.

Primary outcome measures

  • Pain disappearance rate after 12 weeks of treatment [Time frame: 12 Weeks]
Secondary outcome measures (7)
  • Pain disappearance rate after 4 and 8 weeks of treatment [Time frame: 8 Weeks]
  • Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment [Time frame: 12 Weeks]
  • The area under the VAS score-time curve [Time frame: 12 Weeks]
  • McCormick Scale [Time frame: 12 Weeks]
  • General quality of life (Short Form-12) scale [Time frame: 12 Weeks]
  • Disease efficacy evaluation [Time frame: 12 Weeks]
  • Adverse events (AEs) [Time frame: 12 Weeks]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT05970783 · Z-JCP-T-Ⅲ-2021-BJKC-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗