Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo (GB)
Recruitment status was Recruiting
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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 |
- Repigmentation (more than 50% from baseline) as the primary outcome [ Time Frame: 3,6 and 9 months ] [ Designated as safety issue: Yes ]
- 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 |
-
Dietary Supplement: GINGKO BILOBA
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 (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01006421
| Contact: KHALID M ALGHAMDI, MD | 4690815 | kmgderm@yahoo.com |
| 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 | |
| Study Chair: | KHALID M ALGHAMDI, MD | KSU |
More Information
| 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 September 23, 2016