Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
1 other identifier
interventional
240
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2018
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2018
CompletedFirst Posted
Study publicly available on registry
February 26, 2018
CompletedStudy Start
First participant enrolled
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedFebruary 15, 2019
February 1, 2019
1 year
January 11, 2018
February 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change of Nugent score
3 days, 28 days after the end of treatment compare with baseline
Pattern of Chinese medicine symptoms
0,3 days after the end of treatment
The pH of vaginal secretions
0,3 days, 28 days after the end of treatment
H2O2 concentration of vaginal secretions
0,3 days, 28 days after the end of treatment
Other Outcomes (1)
Number of participants with AEs
from the first dose to 28 days after the end of treatment
Study Arms (2)
Honghe Fujie lotion group
EXPERIMENTALMetronidazole Suppositories group
ACTIVE COMPARATORInterventions
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.
Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, 100078, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, China
Yunnan first people's hospital of Yunnan Province
Kunming, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Second affiliated hospital of shaanxi university of traditional Chinese medicine
Xianyang, China
Qinghai Red Cross Hospital
Xining, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2018
First Posted
February 26, 2018
Study Start
July 26, 2018
Primary Completion
July 31, 2019
Study Completion
February 28, 2020
Last Updated
February 15, 2019
Record last verified: 2019-02