The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
NCT ID: NCT03251560
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
240 participants
INTERVENTIONAL
2016-12-01
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fuke Qianjin capsule
Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,
Fuke Qianjin capsule
Fuke Qianjin capsule 0.8g pills by mouth, three times daily
Placebo oral capsule
placebo pills, 2 pills each time,three times a day, orally, for 2months
Placebo oral capsule
Placebo oral capsule 0.8g pill by mouth, three times daily
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
FEMALE
No
Sponsors
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Second Hospital of Jilin University
OTHER
Shenzhen maternal and child health care hospital
UNKNOWN
Guangzhou Women and Children's Medical Center
OTHER
Aijun Sun
OTHER
Responsible Party
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Aijun Sun
professor
Principal Investigators
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Aijun Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences
Locations
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Lei Li
Beijing, China/Beiing, China
Countries
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Central Contacts
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Facility Contacts
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References
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Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.
Related Links
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Causes of chronic pelvic pain in women
Chronic Pelvic Inflammatory Disease
Other Identifiers
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PID201706
Identifier Type: -
Identifier Source: org_study_id
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