Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

• Status: Unknown status
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: Female

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 Metronidazole Suppositories. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine; Dongfang Hospital Beijing University of Chinese Medicine
• Collaborators: Beijing Compete Pharmaceutical Co., Ltd.; Peking University First Hospital; Shandong Buchang Pharmaceutical Co., Ltd.
• Treatments: Metronidazole

Criteria

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.