The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
Phase 2
- Conditions
- Chronic Pelvic Pain
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03251560
- Lead Sponsor
- Aijun Sun
- Brief Summary
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.
- Detailed Description
Fuke Qianjin capsule has been widely used in clinical medicine to ameliorate the pain caused by chronic pelvic disease.But random control trials on its effects are few.Our study was designed as a prospective random control clinical trials to research its effects.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 240
Inclusion Criteria
- Subject is a female between the age of 18 and 50.
- Subject with a history of pelvic inflammatory disease suffered from one of the symptoms below and one of the signs below: symptoms:1.lower abdominal distension or pain;2.lumbosacral soreness. signs:1. enlarged,cable strip-like fallopian tube with mild tenderness palpated on one side or both sides of the uterine;2.restricted movement or adhesion fixed of the uterine;3.the sacral ligaments thicken and harden with mild tenderness.
- Subject VAS score of pelvic pain ≥4
- Subject without fertility requirements in 2 months
- Subject provides written informed consent.
Exclusion Criteria
- Subject underwent recurrent urinary system infection or interstitial cystitis
- Subject underwent irritable bowel syndrome
- Subject has other complications in addition to chronic pelvis inflammation diseases leading to chronic pelvic pain,such as gynecological malignant disease,irregular vaginal bleeding, endometriosis,adenomyosis,ovarian neoplasm with a diameter >5cm by ultrasound
- Subject is pregnant or lactating.
- Subject has a severe systemic disease, such as cardiovascular system
- Subject has a history of malignancy or radiotherapy.
- Subject has undergone any chronic pelvic pain treatment including antibiotics,paregoric,physiotherapy or any other related treatment within 1month prior to randomization.
- Subject has mental disorder incapable of elementary cooperations.
- Subject has an allergic history to the experimental drug.
- Subject has participated in other clinical researches of medicine within 1month prior to randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo oral capsule Placebo oral capsule placebo pills, 2 pills each time,three times a day, orally, for 2months Fuke Qianjin capsule Fuke Qianjin capsule Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,
- Primary Outcome Measures
Name Time Method Interleukin 6 (IL-6) 5 minutes pro-inflammatory cytokine assessment
Visual Analogue Scale Score(VAS score) of pelvic pain 5 minutes pelvic pain degree related assessment
C-reaction protein(CRP) 5 minutes inflammation response biomarker assessment
Tumor necrosis factor alpha (TNFα) 5 minutes systemic inflammation biomarker assessment
- Secondary Outcome Measures
Name Time Method The Short Form (36) Health Survey (SF-36) 5 minutes health status measure
Short-form McGill Pain Questionnaire (SF-MPQ) 5 minutes pain assessment
Trial Locations
- Locations (1)
Lei Li
🇨🇳Beijing, China/Beiing, China