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A multicenter, randomized, double-blind, placebo-controlled phase III trial of the efficacy and safety of Jincao Tablets in the treatment of chronic pelvic pain with sequelae of pelvic inflammatory disease

A multicenter, randomized, double-blind, placebo-controlled phase III trial of the efficacy and safety of Jincao Tablets in the treatment of chronic pelvic pain with sequelae of pelvic inflammatory disease

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058497
Enrollment
Unknown
Registered
2022-04-10
Start date
2022-07-18
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sequelae of pelvic inflammatory disease Chronic pelvic pain

Interventions

Experimental group:Jincao Pian
Control group:Jincaopian simulation

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of chronic pelvic pain was consistent with the sequelae of pelvic inflammatory disease; 2. TCM syndrome differentiation is dampness-heat stasis syndrome or qi stagnation and blood stasis syndrome; 3. The average pain VAS score >= 4 points one week before enrollment; 4. The Mc Cormack Scale score of physical signs at enrollment ranged from 4 to 12 points (including 4 and 12 points); 5. Female between 18 and 55 years (including 18 and 55 years), sexual life history; 6. Voluntarily participate in the clinical trial, give informed consent and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Pelvic inflammatory disease (acute attack); 2. Pregnant and breastfeeding women, and women of childbearing age who are unwilling to take effective measures to prevent pregnancy during the test period and within 3 months after the end of the test; 3. Critical condition or surgical indications, such as concurrent diffuse peritonitis and sepsis; 4. Previously diagnosed cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic congestion syndrome, and chronic pelvic pain caused by other non-pelvic inflammatory diseases; 5. Specific vaginitis such as vulvovaginal candidiasis, trichomonal vaginitis, bacterial vaginosis, etc. when entering the group; 6. Gynecological tumors (uterine fibroids with a maximum diameter greater than 3 cm and submucosal fibroids), endometriosis, uterine muscle adenosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis and other diseases caused by related symptoms; 7. Placement of intrauterine devices in the past 3 months; lack of uterus and bilateral appendages; 8. Received relevant treatment or took drugs with similar functions and indications within 14 days before the introduction; 9. Any one of the liver function indicators (ALT, AST) exceeds the upper limit of the normal reference value by 1.5 times, and the renal function index Scr exceeds the upper limit of the normal value; 10. Serum CA125 and erythrocyte sedimentation rate exceed 1.5 times the upper limit of normal reference value; 11. Combined with severe cardiovascular, cerebrovascular, hematopoietic system and other serious diseases; 12. Has a history of allergy to the test drug ingredients; 13. Has a history of long-term alcoholism and drug abuse; 14. Mental or mental disabilities; 15. Participated in other clinical trials in the past 3 months; 16. The investigator thinks it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale score for pain;Routine blood test;Urinary routine;liver function;renal function;12-lead electrocardiogram;Pregnancy test;

Countries

China

Contacts

Public ContactTeng Xiuxiang

Beijing Qihuang Science and Technology Co., Ltd.

tengxx@126.com+86 10 87906734

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026