The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease

Chronic Pelvic Pain Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Dose-parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Jincaopian Tablets in Subjects With Chronic Pelvic Pain After Pelvic Inflammatory Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460546
• Other study ID #: Z-JCP-T-II-2020-HMZC-01
• Status: Completed
• Phase: Phase 2
• Start date: January 19, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2022
• Source: Beijing Konruns Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 55 (including 18 and 55) 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 3 months after the trial;
• Critically ill or with surgical indications;
• 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, etc.;
• 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;
• Have a history of allergy to the components of the test drug;
• Participated in other clinical trials within the past 3 months;
• The investigator believes that it is not suitable to participate in this clinical trial.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Inflammatory Disease
• Pelvic Pain

Intervention

Drug:
• Jincaopian Tablets high dose
Jincaopian Tablets 0.2g tid p.o.
• Jincaopian Tablets low dose
Jincaopian Tablets 0.1g tid p.o.

Other:
• Placebo
Placebo tid p.o.

Locations

Country	Name	City	State
China	Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Konruns Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Visual Analog Scale (VAS)	To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.	Baseline to 16 weeks
Primary	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
Primary	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