Back to resultsHonghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Primary Purpose
Bacterial Vaginitis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Honghe Fujie lotion
Metronidazole Suppositories
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginitis
Eligibility Criteria
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.
Sites / Locations
- Dongfang Hospital Affiliated to Beijing University of Chinese MedicineRecruiting
- Beijing Tsinghua Changgung Hospital
- Peking University First Hospital
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
- Yunnan first people's hospital of Yunnan Province
- The First Affiliated Hospital of Xian Jiaotong University
- Second affiliated hospital of shaanxi university of traditional Chinese medicine
- Qinghai Red Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Honghe Fujie lotion group
Metronidazole Suppositories group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change of Nugent score
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Pattern of Chinese medicine symptoms
according to an inquiry list from the perspective of traditional Chinese medicine
The pH of vaginal secretions
using pH test paper for measuring the pH of vaginal secretions
H2O2 concentration of vaginal secretions
the concentration of hydrogen peroxide in the vaginal secretions
Full Information
NCT ID
NCT03446443
First Posted
January 11, 2018
Last Updated
February 13, 2019
Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Peking University First Hospital, Beijing Compete Pharmaceutical Co., Ltd., Shandong Buchang Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03446443
Brief Title
Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Official Title
The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Peking University First Hospital, Beijing Compete Pharmaceutical Co., Ltd., Shandong Buchang Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Honghe Fujie lotion group
Arm Type
Experimental
Arm Title
Metronidazole Suppositories group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Honghe Fujie lotion
Other Intervention Name(s)
Hawthorn nuclear extract
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metronidazole Suppositories
Intervention Description
Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.
Primary Outcome Measure Information:
Title
The percentage of patients with remission according to Nugent score < 7
Description
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.
Time Frame
28 days after the end of treatment
Secondary Outcome Measure Information:
Title
Change of Nugent score
Description
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Time Frame
3 days, 28 days after the end of treatment compare with baseline
Title
Pattern of Chinese medicine symptoms
Description
according to an inquiry list from the perspective of traditional Chinese medicine
Time Frame
0,3 days after the end of treatment
Title
The pH of vaginal secretions
Description
using pH test paper for measuring the pH of vaginal secretions
Time Frame
0,3 days, 28 days after the end of treatment
Title
H2O2 concentration of vaginal secretions
Description
the concentration of hydrogen peroxide in the vaginal secretions
Time Frame
0,3 days, 28 days after the end of treatment
Other Pre-specified Outcome Measures:
Title
Number of participants with AEs
Description
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.
Time Frame
from the first dose to 28 days after the end of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Jin, MD
Phone
8613601382390
Email
zill01@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Xu, MD
Phone
8615701005080
Email
dbab1983@hotmail.com
Facility Information:
Facility Name
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
City
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Jin, MD
First Name & Middle Initial & Last Name & Degree
Zhe Jin, professor
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinping Liao, MD
First Name & Middle Initial & Last Name & Degree
Qinping Liao, MD
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Liu, MD
First Name & Middle Initial & Last Name & Degree
Zhaohui Liu
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaobin Wei
Facility Name
Yunnan first people's hospital of Yunnan Province
City
Kunming
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Zi
Facility Name
The First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruifang An
Facility Name
Second affiliated hospital of shaanxi university of traditional Chinese medicine
City
Xianyang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Li
Facility Name
Qinghai Red Cross Hospital
City
Xining
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Lou
12. IPD Sharing Statement
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Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
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