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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Pelvic Pain
• Intervention / Treatment: Drug: Fuke Qianjin capsule; Drug: Placebo oral capsule

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • China/Beiing
    • Beijing, China/Beiing, China, 100000
      • Recruiting
      • Lei Li
      • Contact: Lei L Li, MD; Phone Number: +86 13911988831; Email: lileigh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Short Form (36) Health Survey (SF-36)	health status measure	5 minutes
Short-form McGill Pain Questionnaire (SF-MPQ)	pain assessment	5 minutes

Collaborators and Investigators

• Sponsor: Aijun Sun
• Collaborators: Second Hospital of Jilin University; Guangzhou Women and Children's Medical Center; Shenzhen maternal and child health care hospital
• Investigators: Principal Investigator: Aijun Sun, MD, Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.

Helpful Links

• Causes of chronic pelvic pain in women

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: August 13, 2017
• First Submitted That Met QC Criteria: August 13, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: chronic pelvic pain; Fuke Qianjin capsule
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Pain; Neurologic Manifestations; Adnexal Diseases; Inflammation; Pelvic Inflammatory Disease; Pelvic Infection; Pelvic Pain
• Other Study ID Numbers: PID201706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Network platform, and the website will be attached later.
• IPD Sharing Time Frame: Within 2 months after the trial complete
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No