Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis

NCT ID: NCT03234517

Last Updated: 2018-08-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-08-31

Brief Summary

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Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

Detailed Description

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Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.

Conditions

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Bacterial Vaginosis Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic

Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days

Group Type EXPERIMENTAL

Vaginal Clindamycin Cream

Intervention Type DRUG

Vaginal Clindamycin Cream

Vaginal Probiotic

Intervention Type DRUG

Vaginal Probiotic

Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic

Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use

Group Type ACTIVE_COMPARATOR

Vaginal Clindamycin Cream

Intervention Type DRUG

Vaginal Clindamycin Cream

Vaginal Probiotic

Intervention Type DRUG

Vaginal Probiotic

Interventions

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Vaginal Clindamycin Cream

Vaginal Clindamycin Cream

Intervention Type DRUG

Vaginal Probiotic

Vaginal Probiotic

Intervention Type DRUG

Other Intervention Names

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dalacin c cream dicoflor vaginal capsules

Eligibility Criteria

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Inclusion Criteria

* more than 18 years
* has recurrent Bacterial Vaginosis

Exclusion Criteria

* pregnancy
* use of other antmicrobial
* not provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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IBRAHIM ABD ELGAFOR

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ibrahim A EL sharkwy

Role: PRINCIPAL_INVESTIGATOR

FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

Locations

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Zagazig University

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ibrahim A EL sharkwy

Role: CONTACT

00966554818576

Mohamed L Elsayed

Role: CONTACT

00201222442467

Other Identifiers

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zuh- 8

Identifier Type: -

Identifier Source: org_study_id

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