Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

Conditions
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Bacterial Vaginitis

Intervention / Treatment
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* Drug: Honghe Fujie lotion
* Drug: Metronidazole Suppositories


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Honghe Fujie lotion group<br> | Drug: Honghe Fujie lotion<br>* Before application，wash the vaginal area with water and dry it. Take10ml Hong He Fujie into dilution bottles，added to 100ml with warm boiled water, using diluted lotion for the rinse of vulva and vagina, twice daily for 7days.<br>* Other names: Hawthorn nuclear extract;|
| Active Comparator: Metronidazole Suppositories group<br> | Drug: Metronidazole Suppositories<br>* Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with remission according to Nugent score < 7 | The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid，calculated by assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) . Nugent score is is the addition of these three sub scales,and can range from 0 to 10. | 28 days after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Nugent score | The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid. | 3 days, 28 days after the end of treatment compare with baseline | 
| Pattern of Chinese medicine symptoms | according to an inquiry list from the perspective of traditional Chinese medicine | 0,3 days after the end of treatment | 
| The pH of vaginal secretions | using pH test paper for measuring the pH of vaginal secretions | 0,3 days, 28 days after the end of treatment | 
| H2O2 concentration of vaginal secretions | the concentration of hydrogen peroxide in the vaginal secretions | 0,3 days, 28 days after the end of treatment |