Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis
NCT ID: NCT03357666
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2016-03-22
2018-03-30
Brief Summary
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Vaginitis in adult women is extremely common and it often results in marked suffering. Epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in US.
The broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.However, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus.
In addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina.
The product, HUDC\_VT, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT(Glucose 400mg/Sodium chloride 200mg)
Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
HUDC_VT (Glucose 400mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT(Glucose 400mg)
Glucose 400mg, once a day, two tablets at a time for 7 days
HUDC_VT (Glucose 400mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT(Sodium chloride 200mg)
Sodium chloride 200mg, once a day, two tablets at a time for 7 days
HUDC_VT (Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
Placebo
Placebo, once a day, two tablets at a time for 7 days
Placebo
Vaginal administration, two tablets once a day for 7 days
Interventions
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HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Glucose 400mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Glucose 400mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
Placebo
Vaginal administration, two tablets once a day for 7 days
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria)
* light gray adherent vaginal discharge
* pH \>4.5
* Presence of clue cells ≥20%
* Positive "10% KOH whiff test"
3. Nugent Score ≥ 4
Exclusion Criteria
2. Patient with candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex virus infection
3. Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization
4. Any condition or circumstance that would interfere with analysis of study results
5. Patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period
19 Years
50 Years
FEMALE
No
Sponsors
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Haudongchun Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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WonSeog Choi
Role: STUDY_CHAIR
Haudongchun Co., Ltd.
Locations
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Korea University Guro Hospital
Seoul, Guro-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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JaeKwan Lee
Role: primary
Other Identifiers
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HUDC-VT-201
Identifier Type: -
Identifier Source: org_study_id