The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
| Registry | NCT03446443 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 240 (Estimated) |
| Sponsor | Dongfang Hospital Beijing University of Chinese Medicine (Other); collaborators: Peking University First Hospital, Beijing Compete Pharmaceutical Co., Ltd., Shandong Buchang Pharmaceutical Co., Ltd. |
| Conditions | Bacterial Vaginitis |
| Interventions | Honghe Fujie lotion, Metronidazole Suppositories (Drug) |
| Dates | start 2018-07-26, primary completion 2019-07-31 (estimated), completion 2020-02-28 (estimated), first posted 2018-02-26, last updated 2019-02-15 |
| Locations | 8 sites in China |
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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 Metronidazole Suppositories. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Honghe Fujie lotion group | Experimental | Drug: Honghe Fujie lotion | |
| Metronidazole Suppositories group | Active comparator | Drug: Metronidazole Suppositories |
Sex: Female, ages: 20 Years to 50 Years
Inclusion Criteria: 1. Premenopausal women with sex history. 2. Age: 20 - 50 years. 3. Clinical diagnosis of Bacterial Vaginosis. 4. Nugent scale ≥7. 5. Patient is willing to participate voluntarily and to sign a written patient informed consent. Exclusion Criteria: 1. Evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, VVC, suspected gonorrhea,HSV infection and pointed condyloma etc.). 2. Pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva(e.g. Vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.). 3. Server gynecopathy(e.g. Gynecological malignant tumor etc.). 4. 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. 5. Patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system). 6. Receiving locally applied drugs within 1 week or currently using vaginal medicines. 7. Significant drug or alcohol abuse or a history of mental illness patients. 8. Researchers determine poor adherence, or any other unsuitable reasons for patients to participate in this study. 9. Diagnosis with other disease that necessities immunosuppressant or hormone therapy. 10. 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. 11. Allergic to one or more components of study medicine.
| Facility | City | Country | Status |
|---|---|---|---|
| Dongfang Hospital Affiliated to Beijing University of Chinese Medicine | Beijing | China | Recruiting |
| Beijing Tsinghua Changgung Hospital | Beijing | China | Not yet recruiting |
| Peking University First Hospital | Beijing | China | Not yet recruiting |
| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | China | Not yet recruiting |
| Yunnan first people's hospital of Yunnan Province | Kunming | China | Not yet recruiting |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | China | Not yet recruiting |
| Second affiliated hospital of shaanxi university of traditional Chinese medicine | Xianyang | China | Not yet recruiting |
| Qinghai Red Cross Hospital | Xining | China | Not yet recruiting |