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

Primary Purpose

Chronic Pelvic Pain

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jincaopian Tablets high dose
Jincaopian Tablets low dose
Placebo
Sponsored by
Beijing Konruns Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Jincaopian Tablets high-dose group

Jincaopian Tablets low-dose group

Placebo group

Arm Description

Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks.

Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks.

Patients receive a matching placebo for 12 weeks.

Outcomes

Primary Outcome Measures

Pain Visual Analog Scale (VAS)
To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.
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.
SF-12 Score
To evaluate the health status of the patients compared with the baseline in each group at weeks 12.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2022
Last Updated
July 13, 2022
Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05460546
Brief Title
The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jincaopian Tablets high-dose group
Arm Type
Experimental
Arm Description
Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks.
Arm Title
Jincaopian Tablets low-dose group
Arm Type
Experimental
Arm Description
Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients receive a matching placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Jincaopian Tablets high dose
Other Intervention Name(s)
ZY5301
Intervention Description
Jincaopian Tablets 0.2g tid p.o.
Intervention Type
Drug
Intervention Name(s)
Jincaopian Tablets low dose
Other Intervention Name(s)
ZY5301
Intervention Description
Jincaopian Tablets 0.1g tid p.o.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tid p.o.
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale (VAS)
Description
To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.
Time Frame
Baseline to 16 weeks
Title
Modified McCormick Scale
Description
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.
Time Frame
Baseline and at Weeks 4, 8, 12, 16
Title
SF-12 Score
Description
To evaluate the health status of the patients compared with the baseline in each group at weeks 12.
Time Frame
Baseline and at Weeks 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuxiang Teng
Organizational Affiliation
Beijing Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

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

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