Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis

Haudongchun

Status and phase: Unknown; Phase 2

Conditions: Haudongchun; HUDC_VT; Bacterial Vaginosis

Treatments: Drug: HUDC_VT (Sodium chloride 200mg); Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg); Drug: Placebo; Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg); Drug: HUDC_VT (Glucose 400mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03357666

HUDC-VT-201

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fertile women

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

1. Pregnant or breast-feeding patient or planning pregnancy
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 5 patient groups, including a placebo group

HUDC_VT(Glucose 200mg/Sodium chloride 200mg)

Experimental group

Description:

Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Treatment:

Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg)

HUDC_VT(Glucose 400mg/Sodium chloride 200mg)

Experimental group

Description:

Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Treatment:

Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg)

HUDC_VT(Glucose 400mg)

Experimental group

Description:

Glucose 400mg, once a day, two tablets at a time for 7 days

Treatment:

Drug: HUDC_VT (Glucose 400mg)

HUDC_VT(Sodium chloride 200mg)

Experimental group

Description:

Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Treatment:

Drug: HUDC_VT (Sodium chloride 200mg)

Placebo

Placebo Comparator group

Description:

Placebo, once a day, two tablets at a time for 7 days

Treatment:

Drug: Placebo