Bacterial Vaginitis
Conditions
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 Metronidazole Suppositories. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.
Interventions
DRUGHonghe Fujie lotion
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.
DRUGMetronidazole Suppositories
Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.
Sponsors
Peking University First Hospital
Beijing Compete Pharmaceutical Co., Ltd.
Shandong Buchang Pharmaceutical Co., Ltd.
Dongfang Hospital Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients with remission according to Nugent score < 7 | 28 days after the end of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Nugent score | 3 days, 28 days after the end of treatment compare with baseline | The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid. |
| Pattern of Chinese medicine symptoms | 0,3 days after the end of treatment | according to an inquiry list from the perspective of traditional Chinese medicine |
| The pH of vaginal secretions | 0,3 days, 28 days after the end of treatment | using pH test paper for measuring the pH of vaginal secretions |
| H2O2 concentration of vaginal secretions | 0,3 days, 28 days after the end of treatment | the concentration of hydrogen peroxide in the vaginal secretions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs | from the first dose to 28 days after the end of treatment | Number of patients with AEs by treatment group and overall. The incidence of AEs will be summarized by system organ class, severity, type of AE, relation of study drug and outcome. |
Countries
China
Contacts
Primary ContactZhe Jin, MD
Backup ContactBin Xu, MD
Outcome results
None listed