The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
试验速览
- 阶段
- 2 期
- 发起方
- Aijun Sun
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Interleukin 6 (IL-6)
研究概览
简要总结
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is a female between the age of 18 and
- •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:
- •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.
排除标准
- •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.
研究组 & 干预措施
Fuke Qianjin capsule
Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,
干预措施: Fuke Qianjin capsule (Drug)
Placebo oral capsule
placebo pills, 2 pills each time,three times a day, orally, for 2months
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Interleukin 6 (IL-6)
时间窗: 5 minutes
pro-inflammatory cytokine assessment
Visual Analogue Scale Score(VAS score) of pelvic pain
时间窗: 5 minutes
pelvic pain degree related assessment
C-reaction protein(CRP)
时间窗: 5 minutes
inflammation response biomarker assessment
Tumor necrosis factor alpha (TNFα)
时间窗: 5 minutes
systemic inflammation biomarker assessment
次要结局
- The Short Form (36) Health Survey (SF-36)(5 minutes)
- Short-form McGill Pain Questionnaire (SF-MPQ)(5 minutes)
研究者
Aijun Sun
professor
Peking Union Medical College Hospital