The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation

Study Overview
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Brief Summary
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A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.

Detailed Description
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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.

Official Title
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The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation

Conditions
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Chronic Pelvic Pain

Intervention / Treatment
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* Drug: Fuke Qianjin capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fuke Qianjin capsule<br>Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months, | Drug: Fuke Qianjin capsule<br>* Fuke Qianjin capsule 0.8g pills by mouth, three times daily<br>|
| Placebo Comparator: Placebo oral capsule<br>placebo pills, 2 pills each time,three times a day, orally, for 2months | Drug: Placebo oral capsule<br>* Placebo oral capsule 0.8g pill by mouth, three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale Score(VAS score) of pelvic pain | pelvic pain degree related assessment | 5 minutes | 
| C-reaction protein(CRP) | inflammation response biomarker assessment | 5 minutes | 
| Interleukin 6 (IL-6) | pro-inflammatory cytokine assessment | 5 minutes | 
| Tumor necrosis factor alpha (TNFα) | systemic inflammation biomarker assessment | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Short Form (36) Health Survey (SF-36) | health status measure | 5 minutes | 
| Short-form McGill Pain Questionnaire (SF-MPQ) | pain assessment | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fuke Qianjin capsule, chronic pelvic pain