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

Vitiligo Clinical Trial

— GB  

Official title:

Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01006421
• Other study ID #: GB-NBVUB
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2009
• Last updated: November 4, 2009
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: November 2009
• Source: King Saud University
• Contact: KHALID M ALGHAMDI, MD
• Phone: 4690815
• Email: kmgderm[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vitiligo

Intervention

Dietary Supplement:
• GINGKO BILOBA
MEMOREX 60 MG BID

Locations

Country	Name	City	State
Saudi Arabia	King Khalid University Hospital	Riyadh	Central

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	University Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repigmentation (more than 50% from baseline) as the primary outcome		3,6 and 9 months	Yes
Secondary	Quality-of-life - as secondary outcome .		3,6 and 9 months	Yes