Status:
UNKNOWN
The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
Lead Sponsor:
Aijun Sun
Collaborating Sponsors:
Second Hospital of Jilin University
Shenzhen maternal and child health care hospital
Conditions:
Chronic Pelvic Pain
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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 pros...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03251560
Start Date
December 1 2016
End Date
December 31 2018
Last Update
February 5 2018
Active Locations (1)
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1
Lei Li
Beijing, China/Beiing, China, 100000