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The objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after HUDC-VT administration compared to placebo in patients with bacterial vaginosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HUDC_VT(Glucose 200mg/Sodium chloride 200mg) | Experimental | Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days |
|
| HUDC_VT(Glucose 400mg/Sodium chloride 200mg) | Experimental | Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days |
|
| HUDC_VT(Glucose 400mg) | Experimental | Glucose 400mg, once a day, two tablets at a time for 7 days |
|
| HUDC_VT(Sodium chloride 200mg) | Experimental | Sodium chloride 200mg, once a day, two tablets at a time for 7 days |
|
| Placebo | Placebo Comparator | Placebo, once a day, two tablets at a time for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HUDC_VT(Glucose 200mg/Sodium chloride 200mg) | Drug | Vaginal administration, two tablets once a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment | at 2 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic cure rate of bacterial vaginosis at last treatment | at 7 days | |
| proportion of patients with Normal Nugent score | at 2 weeks after last treatment | |
| proportion of patients with Normal Hay/Ison grade |
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Inclusion Criteria:
Fertile women
Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria)
Nugent Score ≥ 4
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MiYeon Choi | Contact | +82 70-7729-5704 | cbg@hudc.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| WonSeog Choi | Haudongchun Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Recruiting | Seoul | Guro-gu | 08308 | South Korea |
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| HUDC_VT (Glucose 400mg/Sodium chloride 200mg) | Drug | Vaginal administration, two tablets once a day for 7 days |
|
| HUDC_VT (Glucose 400mg) | Drug | Vaginal administration, two tablets once a day for 7 days |
|
| HUDC_VT (Sodium chloride 200mg) | Drug | Vaginal administration, two tablets once a day for 7 days |
|
| Placebo | Drug | Vaginal administration, two tablets once a day for 7 days |
|
| at 2 weeks after last treatment |
| proportion of patients with Normal Vaginal Fluid pH | at 2 weeks after last treatment |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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