Clinical trial NCT03251560: The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
Official title: The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Pelvic Pain
Keywords: Fuke Qianjin capsule
chronic pelvic pain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Second Hospital of Jilin University
name: Shenzhen maternal and child health care hospital
name: Guangzhou Women and Children's Medical Center
First posted: 2017-08-16
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale Score(VAS score) of pelvic pain
timeFrame: 5 minutes
measure: C-reaction protein(CRP)
timeFrame: 5 minutes
measure: Interleukin 6 (IL-6)
timeFrame: 5 minutes
measure: Tumor necrosis factor alpha (TNFα)
timeFrame: 5 minutes
Secondary outcomes:
measure: The Short Form (36) Health Survey (SF-36)
timeFrame: 5 minutes
measure: Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: China/Beiing
Study officials:
affiliation: Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences
name: Aijun Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.