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

NCT03251560 | Unknown Phase 2

• 1 other identifier: PID201706
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pelvic Pain

Keywords

Fuke Qianjin capsule; chronic pelvic pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• The Short Form (36) Health Survey (SF-36)

  5 minutes

• Short-form McGill Pain Questionnaire (SF-MPQ)

  5 minutes

Study Arms (2)

Fuke Qianjin capsule

EXPERIMENTAL

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

Drug: Fuke Qianjin capsule

Placebo oral capsule

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

Fuke Qianjin capsule DRUG

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

Fuke Qianjin capsule

Placebo oral capsule DRUG

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

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aijun Sun: lead
• Second Hospital of Jilin University: collaborator
• Shenzhen maternal and child health care hospital: collaborator
• Guangzhou Women and Children's Medical Center: collaborator

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

RECRUITING

Related Publications (1)

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

  PMID: 25162265 BACKGROUND

Related Links

• Causes of chronic pelvic pain in women
• Chronic Pelvic Inflammatory Disease

Study Officials

• Aijun Sun, MD

  Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, MD

CONTACT

13911988831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo

Study Record Dates

• First Submitted: August 13, 2017
• First Posted: August 16, 2017
• Study Start: December 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 2 months after the trial complete
• Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)