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

A

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

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

Trial contacts and locations

1

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Central trial contact

Lei Li, MD

Data sourced from clinicaltrials.gov

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