Chronic Pelvic PainPhase 3NCT05970783
A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
A Phase 3 study testing Jincaopian Tablets in people with Chronic Pelvic Pain, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Jincaopian Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2022to Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing, Beijing Municipality
Xiuxiang Teng, +86 010-87906734, tengxx@126.com
Xiuxiang Teng
About this study
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
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
Read the 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.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Jincaopian Tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jincaopian TabletsDrug
Also called ZY5301
Jincaopian Tablets 0.2g tid p.o.
PlaceboOther
Placebo 0.2g tid p.o.
| Study group | Role | What they receive |
|---|---|---|
| Jincaopian Tablets group | Experimental | Patients receive Jincaopian Tablets 0.6g/day for 12 weeks. Receives: Drug: Jincaopian Tablets |
| Placebo group | Placebo comparator | Patients receive a placebo 0.6g/day for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (7)
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.
Measured: 8 Weeks
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.
Measured: 12 Weeks
The area under the VAS score-time curve
AUC under the curve to evaluating pain levels
Measured: 12 Weeks
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
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
Measured: 12 Weeks
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start8 Nov 2022
- Primary completion11 Mar 2024
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiuxiang Teng, Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970783
- Sponsor's protocol ID
- Z-JCP-T-Ⅲ-2021-BJKC-01
- Status last verified
- Oct 2024
- First submitted
- 13 Jul 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05970783
- Acronym / sponsor ID
- Z-JCP-T-Ⅲ-2021-BJKC-01
- Conditions
- Chronic Pelvic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jincaopian Tablets group | Experimental | Drug: Jincaopian TabletsPatients receive Jincaopian Tablets 0.6g/day for 12 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboPatients receive a placebo 0.6g/day for 12 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jincaopian TabletsAlso: ZY5301Jincaopian Tablets 0.2g tid p.o. | Drug | Jincaopian Tablets group |
| PlaceboPlacebo 0.2g tid p.o. | Other | Placebo group |
Primary outcome
Pain disappearance rate after 12 weeks of treatment
Time frame: 12 Weeks
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.
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuxiang Teng principal investigator
Beijing Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jincaopian Tablets in people with Chronic Pelvic Pain, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuxiang Teng (+86 010-87906734, tengxx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain disappearance rate after 12 weeks of treatment (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.