Trial | NCT03251560  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    240
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.
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.
Study Started
Dec 01
2016
Primary Completion
Dec 31
2017
Study Completion
Dec 31
2018
Anticipated
Last Update
Feb 05
2018

Drug Fuke Qianjin capsule

Fuke Qianjin capsule 0.8g pills by mouth, three times daily

Drug Placebo oral capsule

Placebo oral capsule 0.8g pill by mouth, three times daily

Fuke Qianjin capsule Experimental

Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,

Placebo oral capsule Placebo Comparator

placebo pills, 2 pills each time,three times a day, orally, for 2months

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.
No Results Posted