A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease

NCT05970783 | Recruiting Phase 3

• 1 other identifier: Z-JCP-T-Ⅲ-2021-BJKC-01
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks

Secondary Outcomes (7)

• Pain disappearance rate after 4 and 8 weeks of treatment

  8 Weeks

• Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment

  12 Weeks

• The area under the VAS score-time curve

  12 Weeks

• McCormick Scale

  12 Weeks

• General quality of life (Short Form-12) scale

  12 Weeks

Study Arms (2)

Jincaopian Tablets group

EXPERIMENTAL

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

Drug: Jincaopian Tablets

Placebo group

PLACEBO COMPARATOR

Patients receive a placebo 0.6g/day for 12 weeks.

Other: Placebo

Interventions

Jincaopian Tablets DRUG

Jincaopian Tablets 0.2g tid p.o.

Also known as: ZY5301

Jincaopian Tablets group

Placebo OTHER

Placebo 0.2g tid p.o.

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

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 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.

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Xiuxiang Teng

  Beijing Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuxiang Teng

CONTACT

+86 010-87906734; tengxx@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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, 2023
• First Posted: August 1, 2023
• Study Start: November 8, 2022
• Primary Completion: March 11, 2024
• Study Completion: April 1, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

CN (1)