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Trial record 4 of 231 for:    clindamycin

Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03234517
Recruitment Status : Unknown
Verified July 2017 by IBRAHIM ABD ELGAFOR, Zagazig University.
Recruitment status was:  Recruiting
First Posted : July 31, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
IBRAHIM ABD ELGAFOR, Zagazig University

Brief Summary:
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Treatment Drug: Vaginal Clindamycin Cream Drug: Vaginal Probiotic Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic
Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days
Drug: Vaginal Clindamycin Cream
Vaginal Clindamycin Cream
Other Name: dalacin c cream

Drug: Vaginal Probiotic
Vaginal Probiotic
Other Name: dicoflor vaginal capsules

Active Comparator: Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use
Drug: Vaginal Clindamycin Cream
Vaginal Clindamycin Cream
Other Name: dalacin c cream

Drug: Vaginal Probiotic
Vaginal Probiotic
Other Name: dicoflor vaginal capsules




Primary Outcome Measures :
  1. initial cure rate [ Time Frame: 2 months ]
    number of women completely cured


Secondary Outcome Measures :
  1. recurrence rate [ Time Frame: 4,6,8and12 months ]
    number of women had recurrence



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • more than 18 years
  • has recurrent Bacterial Vaginosis

Exclusion Criteria:

  • pregnancy
  • use of other antmicrobial
  • not provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234517


Contacts
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Contact: Ibrahim A EL sharkwy 00966554818576 ibrahimsharkwy@yahoo.com
Contact: Mohamed L Elsayed 00201222442467 drmohamedlotfy@yahoo.com

Locations
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Egypt
Zagazig University Recruiting
Zagazig, Egypt
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Ibrahim A EL sharkwy FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

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Responsible Party: IBRAHIM ABD ELGAFOR, assistant professor, Zagazig University
ClinicalTrials.gov Identifier: NCT03234517     History of Changes
Other Study ID Numbers: zuh- 8
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action