Study information
Study information
The study will involve a total of 5 visits over a 12 week period to the office of Dr. Orest Szczurko, the naturopathic doctor performing the study, at 47 Dundas St. West, in Mississauga.
The first visit will be a 30 minute initial intake visit, during which the naturopathic doctor will answer any questions you may have. Following the signing of the informed consent form, a brief history of the development of your vitiligo, including background information on disease duration, disease activity, presence of an itch before lesions, presence of vitiligo on genitals, and past treatments will be documented. During the same visit the presence of thyroid or other autoimmune diseases, and the presence and number of halo nevus will also be documented. The darkness of your skin will be measured using the Fitzpatrick’s skin type scoring system. The extent of your vitiligo will be measured with 2 forms: the Vitiligo European Task Force (VETF) and the Vitiligo Area Scoring Index (VASI). To further measure the progress, pictures of your vitiligo spots (and only of the vitiligo spots) will be taken under incandescent and Wood’s lamp.
To ensure safety, and catch the rare persons who might be at risk of side effects, the participant will asked to give blood 2 times, at the initial visit and at the end of the clinical trial. Two tubes will be filled, requiring a total of 6 mL of blood, to perform three tests (CBC-complete blood count, PTT-partial thromboplastin time, and the INR-prothrombin time). EMLA, a topical anesthetic, will be used to reduce the pain of the blood draw. The blood will be drawn from a vein, usually from the inside of the elbow. The risks associated with having blood drawn are slight, but may include excessive bleeding, fainting or feeling light headed, bruising, and infection (a slight risk any time the skin is broken).
At the end of the initial visit, you will be scheduled for a follow up appointment in the next 2 weeks. This will be a quick 15 minute appointment, during which a dermatologist will confirm the diagnosis of vitiligo, and will give you the first of 3 bottles of Ginkgo biloba for you to take. You will be asked to take the Ginkgo biloba 1 pill at a time, 10 minutes before eating, 2 times per day.
The next 3 visits will be scheduled every 4 weeks and will be 30 minutes long. At each visit, the vitiligo lesions will be evaluated using the VETF and VAS, and will the photographed. You will be asked about any adverse reactions or side effects experienced after taking the Ginkgo biloba. You will be asked to bring in the bottle of pills from the previous appointment and be given a fresh bottle of the same Ginkgo biloba pills.
The benefits you may experience are decreased or stopping of the progression of the vitiligo spots, and repigmentation of the vitiligo spots. You will also contribute to the general knowledge and research on the treatments of vitiligo and Ginkgo biloba.
As Ginkgo biloba is a medically active herb, there may be some risks to taking it. Some of the reported side effects of Ginkgo biloba that have been reported include: a decrease in systolic and diastolic blood pressure, allergic reactions such as rashes, nausea, diarrhea, vomiting, stomach pain, muscle weakness, headache, dizziness, restlessness, or bleeding. These side effects appear to occur rarely and have only been documented to date in older adults. To ensure the safety of each participant, you will be asked to write down any side effect symptoms, and immediately call the treating naturopathic doctor to report the significant symptoms.
Other than the free treatment time and free supplements, you will receive no other compensation.