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

Aijun Sun

Status and phase: Unknown; Phase 2

Conditions: Chronic Pelvic Pain

Treatments: Drug: Fuke Qianjin capsule; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03251560

PID201706

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Fuke Qianjin capsule

Experimental group

Description:

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

Treatment:

Drug: Fuke Qianjin capsule

Placebo oral capsule

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral capsule