VitiligoGBNCT01006421
Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo
An observational study of Vitiligo, run by King Saud University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- GINGKO BILOBA
- How many people
- 160 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: DERMATOLOGY CLINIC
Who may be able to join
- Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.
- Body surface area (BSA) involvement ≥ 3%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Khalid University Hospital
Riyadh, Central
KHALID M ALGHAMDI, MD, 4690815, kmgderm@yahoo.com
KHALID M ALGHAMDI, MD
About this study
Official title: Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- GINGKO BILOBA
- Keywords
- phototherapy, Gingko biloba, repigmentation
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GINGKO BILOBADietary supplement
MEMOREX 60 MG BID
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation (more than 50% from baseline) as the primary outcome
Measured: 3,6 and 9 months
Secondary outcomes (1)
Quality-of-life - as secondary outcome .
Measured: 3,6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJan 2009
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital
- Investigators
- KHALID M ALGHAMDI, MD, Study chair, KSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006421
- Sponsor's protocol ID
- GB-NBVUB
- Acronym
- GB
- Status last verified
- Nov 2009
- First submitted
- 1 Nov 2009
- Last updated
- 5 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01006421
- Acronym / sponsor ID
- GB / GB-NBVUB
- Conditions
- Vitiligo
- Keywords
- phototherapy, Gingko biloba, repigmentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- University Hospital
- Study start
- Jan 2009
- Study completion
- Jan 2011 (estimated)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- DERMATOLOGY CLINIC
Key inclusion criteria (2 listed)
- Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.
- Body surface area (BSA) involvement ≥ 3%.
Key exclusion criteria (6 listed)
- Unable to consent
- Any topical, systemic or phototherapy for Vitiligo in the previous 2 months.
- Pregnancy, breast feeding.
- Liver or kidney disease.
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GINGKO BILOBAMEMOREX 60 MG BID | Dietary supplement | – |
Primary outcome
Repigmentation (more than 50% from baseline) as the primary outcome
Time frame: 3,6 and 9 months
1 secondary outcome
Quality-of-life - as secondary outcome .
Time frame: 3,6 and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2009.
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KHALID M ALGHAMDI, MD study chair
KSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KHALID M ALGHAMDI, MD (4690815, kmgderm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation (more than 50% from baseline) as the primary outcome (time frame: 3,6 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2009.