NCT05460546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

July 13, 2022

Last Update Submit

July 13, 2022

Conditions

Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (3)

  • Pain Visual Analog Scale (VAS)

    To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.

    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.

    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.

    Baseline and at Weeks 12

Study Arms (3)

Jincaopian Tablets high-dose group

EXPERIMENTAL

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

Drug: Jincaopian Tablets high dose

Jincaopian Tablets low-dose group

EXPERIMENTAL

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

Drug: Jincaopian Tablets low dose

Placebo group

PLACEBO COMPARATOR

Patients receive a matching placebo for 12 weeks.

Other: Placebo

Interventions

Jincaopian Tablets high doseDRUG

Jincaopian Tablets 0.2g tid p.o.

Also known as: ZY5301
Jincaopian Tablets high-dose group
Jincaopian Tablets low doseDRUG

Jincaopian Tablets 0.1g tid p.o.

Also known as: ZY5301
Jincaopian Tablets low-dose group
PlaceboOTHER

Placebo tid p.o.

Placebo group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • 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.

    PMID: 39042407DERIVED

Study Officials

  • Xiuxiang Teng

    Beijing Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 15, 2022

Study Start

January 19, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

CN(1)