Status:
UNKNOWN
Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Lead Sponsor:
Dongfang Hospital Beijing University of Chinese Medicine
Collaborating Sponsors:
Peking University First Hospital
Beijing Compete Pharmaceutical Co., Ltd.
Conditions:
Bacterial Vaginitis
Eligibility:
FEMALE
20-50 years
Phase:
PHASE4
Brief Summary
This is a Randomized, Positive -Controlled, Multi-center Trial enrolling 240 subjects with Bacterial Vaginosis who will be randomized at a ratio of 1:1 to receive active Honghe Fujie lotion or Metroni...
Eligibility Criteria
Inclusion
- Premenopausal women with sex history.
- Age: 20 - 50 years.
- Clinical diagnosis of Bacterial Vaginosis.
- Nugent scale ≥7.
- Patient is willing to participate voluntarily and to sign a written patient informed consent.
Exclusion
- Evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, VVC, suspected gonorrhea，HSV infection and pointed condyloma etc.).
- Pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva（e.g. Vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.).
- Server gynecopathy（e.g. Gynecological malignant tumor etc.）.
- Liver function impairment with the value of ALT or AST over 2-fold of normal value.Renal dysfunction with the value of serum creatinine over normal value.
- Patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system).
- Receiving locally applied drugs within 1 week or currently using vaginal medicines.
- Significant drug or alcohol abuse or a history of mental illness patients.
- Researchers determine poor adherence, or any other unsuitable reasons for patients to participate in this study.
- Diagnosis with other disease that necessities immunosuppressant or hormone therapy.
- Pregnancy, breast feeding and the possible pregnancy during study. Patient who is participating in other trials or has been participated in other trials in recent 1 months.
- Allergic to one or more components of study medicine.
Key Trial Info
Start Date :
July 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2020
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03446443
Start Date
July 26 2018
End Date
February 28 2020
Last Update
February 15 2019
Active Locations (8)
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1
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, China, 100078
2
Beijing Tsinghua Changgung Hospital
Beijing, China
3
Peking University First Hospital
Beijing, China
4
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, China