Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo (GB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by King Saud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital
Information provided by:
King Saud University
ClinicalTrials.gov Identifier:
NCT01006421
First received: November 1, 2009
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant psychosocial impact on patients and society. Different treatment modalities with variable success rates are available.

Phototherapy is among the successful treatments but gives modest results. Some reports documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.


Condition Intervention
Vitiligo
Dietary Supplement: GINGKO BILOBA

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Repigmentation (more than 50% from baseline) as the primary outcome [ Time Frame: 3,6 and 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality-of-life - as secondary outcome . [ Time Frame: 3,6 and 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Intervention Details:
    Dietary Supplement: GINGKO BILOBA
    MEMOREX 60 MG BID
Detailed Description:

Adding GB to phototherapy, especially the most commonly used one; Narrow-Band UVB (NBUVB) might give better results than using either one alone. This might improve repigmentation as well as patients' quality-of-life. (QOL).

This will be a prospective double-blind randomized controlled clinical trial. One-hundred-sixty Vitiligo patients will be randomly divided into 2 groups( 80 patients per group).

One group will receive oral GB (2 tablets of 60 mgs twice daily) with NBUVB twice weekly.

The other group will receive placebo tablets( identical in size, shape and color) to GB twice daily with NBUVB twice weekly.

Both groups will be treated for 6 months. Standard protocol of phototherapy will be used for both groups.

Our aim here is to see whether adding GB to NBUVB will lead to better repigmentation than placebo or not.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

DERMATOLOGY CLINIC

Criteria

Inclusion Criteria:

  • Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.
  • Body surface area (BSA) involvement ≥ 3%.

Exclusion Criteria:

  • Unable to consent
  • Any topical, systemic or phototherapy for Vitiligo in the previous 2 months.
  • Pregnancy, breast feeding.
  • Liver or kidney disease.
  • Epilepsy
  • Bleeding disorder or anticoagulant treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006421

Contacts
Contact: KHALID M ALGHAMDI, MD 4690815 kmgderm@yahoo.com

Locations
Saudi Arabia
King Khalid University Hospital Recruiting
Riyadh, Central, Saudi Arabia
Contact: KHALID M ALGHAMDI, MD    4690815    kmgderm@yahoo.com   
Principal Investigator: KHALID M ALGHAMDI, MD         
Sponsors and Collaborators
King Saud University
University Hospital
Investigators
Study Chair: KHALID M ALGHAMDI, MD KSU
  More Information

No publications provided

Responsible Party: DR KHALID ALGHAMDI, KSU
ClinicalTrials.gov Identifier: NCT01006421     History of Changes
Other Study ID Numbers: GB-NBVUB
Study First Received: November 1, 2009
Last Updated: November 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by King Saud University:
phototherapy
Gingko biloba
repigmentation

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014