Back to resultsA Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
Primary Purpose
Chronic Pelvic Pain
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jincaopian Tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain
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.
Sites / Locations
- Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Jincaopian Tablets group
Placebo group
Arm Description
Patients receive Jincaopian Tablets 0.6g/day for 12 weeks.
Patients receive a placebo 0.6g/day for 12 weeks.
Outcomes
Primary Outcome Measures
Pain disappearance rate after 12 weeks of treatment
The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
Secondary Outcome Measures
Pain disappearance rate after 4 and 8 weeks of treatment
The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment
Visual Analogue Scale (VAS) was used to evaluate pelvic pain degree. The VAS score ranged from 0 to 10, and a higher score represented greater pain intensity. The average VAS value for a week was calculated by dividing the sum of the scores for each day of the week by the number of days the score was recorded.
The area under the VAS score-time curve
AUC under the curve to evaluating pain levels
McCormick Scale
The McCormack scale was used to score the patient's physical signs. The total score is 36 points, rated from twelve aspects including uterine tenderness (divided into four quadrants), abdominal tenderness or rebound pain (divided into four quadrants), left or right adnexal tenderness, uterine tenderness, and cervical lifting and swinging pain. The scoring criteria was as following: no pain is 0 points; Mild pain without facial expression changes and muscle tension is 1 point; Pain accompanied by facial expressions and muscle tension is 2 points; Pain drama is 3 points.
General quality of life (Short Form-12) scale
The Short Form-12 is an abbreviated version of the original 36-item QOL questionnaire. It comprises 12 items with a mental component summary (MCS) and a physical component summary (PCS). Possible scores for mental and physical health-related QOL subscales range from 0 to 100 points, and a higher score is interpreted as better QOL.
Disease efficacy evaluation
Disease efficacy was determined based on the change of the clinical signs and symptoms.
Based on the evaluation criteria, the Disease efficacy was recorded as Clinical recovery, significant effect, effectiveness, and ineffectiveness.
Clinical recovery: The symptoms and signs disappear, and the integral values of symptoms, signs, and auxiliary examinations decrease by ≥ 95%.
Significant effect: The symptoms and signs are significantly reduced, with a reduction of ≥ 70% and<95% in the score of symptoms, signs, and auxiliary examinations.
Effective: Symptoms and signs have been alleviated, with a reduction of ≥ 30% and<70% in symptom, sign, and auxiliary examination scores.
Invalid: No reduction or aggravation of symptoms and signs, with a decrease of<30% in the score of symptoms, signs, and auxiliary examinations
Adverse events (AEs)
Incidence of treatment-related AEs
Full Information
NCT ID
NCT05970783
First Posted
July 13, 2023
Last Updated
July 29, 2023
Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05970783
Brief Title
A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
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
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.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jincaopian Tablets group
Arm Type
Experimental
Arm Description
Patients receive Jincaopian Tablets 0.6g/day for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients receive a placebo 0.6g/day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Jincaopian Tablets
Other Intervention Name(s)
ZY5301
Intervention Description
Jincaopian Tablets 0.2g tid p.o.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo 0.2g tid p.o.
Primary Outcome Measure Information:
Title
Pain disappearance rate after 12 weeks of treatment
Description
The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Pain disappearance rate after 4 and 8 weeks of treatment
Description
The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
Time Frame
8 Weeks
Title
Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment
Description
Visual Analogue Scale (VAS) was used to evaluate pelvic pain degree. The VAS score ranged from 0 to 10, and a higher score represented greater pain intensity. The average VAS value for a week was calculated by dividing the sum of the scores for each day of the week by the number of days the score was recorded.
Time Frame
12 Weeks
Title
The area under the VAS score-time curve
Description
AUC under the curve to evaluating pain levels
Time Frame
12 Weeks
Title
McCormick Scale
Description
The McCormack scale was used to score the patient's physical signs. The total score is 36 points, rated from twelve aspects including uterine tenderness (divided into four quadrants), abdominal tenderness or rebound pain (divided into four quadrants), left or right adnexal tenderness, uterine tenderness, and cervical lifting and swinging pain. The scoring criteria was as following: no pain is 0 points; Mild pain without facial expression changes and muscle tension is 1 point; Pain accompanied by facial expressions and muscle tension is 2 points; Pain drama is 3 points.
Time Frame
12 Weeks
Title
General quality of life (Short Form-12) scale
Description
The Short Form-12 is an abbreviated version of the original 36-item QOL questionnaire. It comprises 12 items with a mental component summary (MCS) and a physical component summary (PCS). Possible scores for mental and physical health-related QOL subscales range from 0 to 100 points, and a higher score is interpreted as better QOL.
Time Frame
12 Weeks
Title
Disease efficacy evaluation
Description
Disease efficacy was determined based on the change of the clinical signs and symptoms.
Based on the evaluation criteria, the Disease efficacy was recorded as Clinical recovery, significant effect, effectiveness, and ineffectiveness.
Clinical recovery: The symptoms and signs disappear, and the integral values of symptoms, signs, and auxiliary examinations decrease by ≥ 95%.
Significant effect: The symptoms and signs are significantly reduced, with a reduction of ≥ 70% and<95% in the score of symptoms, signs, and auxiliary examinations.
Effective: Symptoms and signs have been alleviated, with a reduction of ≥ 30% and<70% in symptom, sign, and auxiliary examination scores.
Invalid: No reduction or aggravation of symptoms and signs, with a decrease of<30% in the score of symptoms, signs, and auxiliary examinations
Time Frame
12 Weeks
Title
Adverse events (AEs)
Description
Incidence of treatment-related AEs
Time Frame
12 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuxiang Teng
Phone
+86 010-87906734
Email
tengxx@126.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuxiang Teng
Phone
+86 010-87906734
Email
tengxx@126.com
First Name & Middle Initial & Last Name & Degree
Xiuxiang Teng
12. IPD Sharing Statement
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A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
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