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

Chronic Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251560
• Other study ID #: PID201706
• Status: Recruiting
• Phase: Phase 2
• First received: August 13, 2017
• Last updated: February 2, 2018
• Start date: December 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, MD
• Phone: 13911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Inflammation
• Pelvic Inflammatory Disease
• Pelvic Pain

Intervention

Drug:
• Fuke Qianjin capsule
Fuke Qianjin capsule 0.8g pills by mouth, three times daily
• Placebo oral capsule
Placebo oral capsule 0.8g pill by mouth, three times daily

Locations

Country	Name	City	State
China	Lei Li	Beijing	China/Beiing

Sponsors (4)

Lead Sponsor	Collaborator
Aijun Sun	Guangzhou Women and Children's Medical Center, Second Hospital of Jilin University, Shenzhen maternal and child health care hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-29. doi: 10.1097/AOG.0000000000000417. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Score(VAS score) of pelvic pain	pelvic pain degree related assessment	5 minutes
Primary	C-reaction protein(CRP)	inflammation response biomarker assessment	5 minutes
Primary	Interleukin 6 (IL-6)	pro-inflammatory cytokine assessment	5 minutes
Primary	Tumor necrosis factor alpha (TNFa)	systemic inflammation biomarker assessment	5 minutes
Secondary	The Short Form (36) Health Survey (SF-36)	health status measure	5 minutes
Secondary	Short-form McGill Pain Questionnaire (SF-MPQ)	pain assessment	5 minutes

External Links

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