Chronic Pelvic Pain
Conditions
Keywords
Fuke Qianjin capsule, chronic pelvic pain
Brief summary
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.
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.
Interventions
DRUGFuke Qianjin capsule
Fuke Qianjin capsule 0.8g pills by mouth, three times daily
DRUGPlacebo oral capsule
Placebo oral capsule 0.8g pill by mouth, three times daily
Sponsors
Second Hospital of Jilin University
Shenzhen maternal and child health care hospital
Guangzhou Women and Children's Medical Center
Aijun Sun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale Score(VAS score) of pelvic pain | 5 minutes | pelvic pain degree related assessment |
| C-reaction protein(CRP) | 5 minutes | inflammation response biomarker assessment |
| Interleukin 6 (IL-6) | 5 minutes | pro-inflammatory cytokine assessment |
| Tumor necrosis factor alpha (TNFα) | 5 minutes | systemic inflammation biomarker assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Short Form (36) Health Survey (SF-36) | 5 minutes | health status measure |
| Short-form McGill Pain Questionnaire (SF-MPQ) | 5 minutes | pain assessment |
Countries
China
Contacts
Primary ContactLei Li, MD
Outcome results
None listed