Chronic Pelvic PainPhase 2NCT05460546
The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
A Phase 2 study testing Jincaopian Tablets high dose and Jincaopian Tablets low dose in people with Chronic Pelvic Pain, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Jincaopian Tablets high dose and Jincaopian Tablets low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2021to 30 Nov 2021
- Phase
- Phase 2
- 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 55 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 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.
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 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing, Beijing Municipality
About this study
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
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.
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 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.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Jincaopian Tablets high dose, Jincaopian Tablets low dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jincaopian Tablets high doseDrug
Also called ZY5301
Jincaopian Tablets 0.2g tid p.o.
Jincaopian Tablets low doseDrug
Also called ZY5301
Jincaopian Tablets 0.1g tid p.o.
PlaceboOther
Placebo tid p.o.
| Study group | Role | What they receive |
|---|---|---|
| Jincaopian Tablets high-dose group | Experimental | Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks. Receives: Drug: Jincaopian Tablets high dose |
| Jincaopian Tablets low-dose group | Experimental | Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks. Receives: Drug: Jincaopian Tablets low dose |
| Placebo group | Placebo comparator | Patients receive a matching placebo for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale (VAS)
To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.
Measured: Baseline to 16 weeks
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.
Measured: Baseline and 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.
Measured: Baseline and at Weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start19 Jan 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
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
- NCT05460546
- Sponsor's protocol ID
- Z-JCP-T-II-2020-HMZC-01
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Teng X, Li H, Yang D, Gao Z, Cui L, Chen H, Song Q, Xu L, Li H, Zhang Q, Wu J, Leng J. ZY5301 Tablet vs Placebo for Treatment of Chronic Pelvic Pain After Pelvic Inflammatory Disease: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2423229. doi: 10.1001/jamanetworkopen.2024.23229.
PubMed 39042407
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. 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 II Clinical Trial to Evaluate the Efficacy and Safety of Jincaopian Tablets in Subjects With Chronic Pelvic Pain After Pelvic Inflammatory Disease
- ClinicalTrials.gov ID
- NCT05460546
- Acronym / sponsor ID
- Z-JCP-T-II-2020-HMZC-01
- Conditions
- Chronic Pelvic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 15 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jincaopian Tablets high-dose group | Experimental | Drug: Jincaopian Tablets high dosePatients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks. |
| Jincaopian Tablets low-dose group | Experimental | Drug: Jincaopian Tablets low dosePatients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboPatients receive a matching placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 55 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 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.
Key exclusion criteria (11 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 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.;
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 Tablets high doseAlso: ZY5301Jincaopian Tablets 0.2g tid p.o. | Drug | Jincaopian Tablets high-dose group |
| Jincaopian Tablets low doseAlso: ZY5301Jincaopian Tablets 0.1g tid p.o. | Drug | Jincaopian Tablets low-dose group |
| PlaceboPlacebo tid p.o. | Other | Placebo group |
Primary outcome
Pain Visual Analog Scale (VAS)
Time frame: Baseline to 16 weeks
To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.
Modified McCormick Scale
Time frame: Baseline and at Weeks 4, 8, 12, 16
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
Time frame: Baseline and at Weeks 12
To evaluate the health status of the patients compared with the baseline in each group at weeks 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Derived from this study: PubMed 39042407Teng X, Li H, Yang D, Gao Z, Cui L, Chen H, Song Q, Xu L, Li H, Zhang Q, Wu J, Leng J. ZY5301 Tablet vs Placebo for Treatment of Chronic Pelvic Pain After Pelvic Inflammatory Disease: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2423229. doi: 10.1001/jamanetworkopen.2024.23229.
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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 2 study testing Jincaopian Tablets high dose and Jincaopian Tablets low dose 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 11 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: finished, as of the sponsor's last update on 15 Jul 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analog Scale (VAS) (time frame: Baseline to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460546, which also lists 1 linked publication.
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 15 Jul 2022.