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

Sponsor

Aijun Sun (Other)

Overall Status

Unknown status

CT.gov ID

NCT03251560

Collaborator

Second Hospital of Jilin University (Other), Shenzhen maternal and child health care hospital (Other), Guangzhou Women and Children's Medical Center (Other)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pelvic Pain	Drug: Fuke Qianjin capsule Drug: Placebo oral capsule	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebohalf of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Fuke Qianjin capsule

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

Drug: Fuke Qianjin capsule

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

Placebo Comparator: Placebo oral capsule

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

Drug: Placebo oral capsule

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The Short Form (36) Health Survey (SF-36) [5 minutes]
health status measure
Short-form McGill Pain Questionnaire (SF-MPQ) [5 minutes]
pain assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.