Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

Dongfang Hospital Beijing University of Chinese Medicine

Status and phase: Unknown; Phase 4

Conditions: Bacterial Vaginitis

Treatments: Drug: Honghe Fujie lotion; Drug: Metronidazole Suppositories

Study type: Interventional

Funder types: Other

Identifiers

NCT03446443

KPT-RCT-2017-01

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Honghe Fujie lotion group

Experimental group

Treatment:

Drug: Honghe Fujie lotion

Metronidazole Suppositories group

Active Comparator group

Treatment:

Drug: Metronidazole Suppositories