Actively Recruiting

Phase 3
Age: 18Years - 50Years
FEMALE
NCT05970783

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

Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-10-17

414

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the diagnostic criteria for chronic pelvic pain sequelae of pelvic inflammatory disease
  • Average pain score (VAS) of 4 or higher in the week before enrollment
  • Physical signs score (McCormack scale) between 4 and 12 points at enrollment
  • Female aged 18 to 50 years with a history of sexual activity
  • Voluntarily agree to participate and sign informed consent form
Not Eligible

You will not qualify if you...

  • Having an acute pelvic inflammatory disease attack
  • Pregnant or breastfeeding, or unwilling to use effective contraception during and 6 months after the trial
  • Diagnosed with cervical intraepithelial neoplasia, primary or secondary dysmenorrhea, pelvic stasis syndrome, or chronic pelvic pain from non-pelvic inflammatory causes
  • Having specific vaginitis such as vulvovaginal candidiasis, trichomonas vaginitis, or bacterial vaginosis
  • Having gynecological tumors (uterine fibroids larger than 3 cm or submucosal fibroids), endometriosis, adenomyosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis, or related symptoms
  • Had intrauterine device placement within the past 3 months; absence of uterus and both adnexa
  • Received related treatments or similar drugs within 14 days before enrollment
  • Liver function with ALT or AST above 1.5 times the normal upper limit; kidney function with serum creatinine above normal upper limit
  • Serum CA125 or erythrocyte sedimentation rate above 1.1 times the normal upper limit
  • Having serious cardiovascular, cerebrovascular, hematopoietic, or other serious diseases
  • Allergy to the experimental drug
  • History of long-term alcoholism or drug abuse
  • Intellectual disabilities or mental disorders
  • Participated in other clinical trials within the last 3 months
  • Investigator judges unsuitability for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

X

Xiuxiang Teng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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