Intervention : Topical Melatonin(3%) at dosage of 15 mg once daily

Oral Leukoplakia

Topical melatonin at 3% concentration with dosage of 15 mg once daily will be applied on the lesion for 6 weeks followed by a follow up of 3 months

topical melatonin

Topical application of placebo once daily for 6 weeks with a follow up for 3 months

PLACEBO

Post graduate institute of dental sciences

Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia

Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia: A Randomized Placebo Controlled Study

measurement of the lesion and scored according to RECIST criteria

Grading of dysplasia according to Speight classification (2007).

Percentage of a total number of Ki-67 positive cells to a total number of cells will be primarily deducted.

Postgraduate Institute of Dental Sciences Rohtak

A dose of lycopene (20 mg) is provided as part of an emulsified liquid meal (with or without 160 mg powdered ferrous sulfate). Samples from the upper digestive tract (gastric or duodenal) are aspirated over 4 hours, and blood collected over 7 hours. Blood plasma and chylomicron fractions isolated. The subject returns for 3 additional visits with 2 weeks between each visit. The same protocol is followed, with the subject receiving all combinations of meal (w/ and w/o iron) and upper digestive tract sampling (gastric or duodenal)

A dose of 13C beta-carotene (20 mg) is provided as part of an emulsified liquid meal. Samples from the upper digestive tract (gastric or duodenal) are aspirated over 5 hours, blood collected over 7 hours, and urine collected over 7 hours. Blood plasma and chylomicron fractions isolated. The subject returns for 1 additional visit with a minimum of 4 weeks between each visit. The same protocol is followed, with sampling taken from the remaining upper digestive tract compartment (gastric or duodenal)

The same procedure is followed (as detailed in the experimental arms) but the subject receives an emulsified liquid meal without carotenoids or vitamin E.

Digestion Chambers

Stability and Metabolism of Carotenoids and Vitamin E

lycopene

beta-carotene

control

Centre d'Investigation Clinique de la Hôpital Conception

Lycopene and Beta-carotene Metabolism in the Digestive Tract of Healthy Men

Métabolismes Des caroténoïdes Dans la lumière du Tube Digestif de l'Homme Sain

Patrick Borel

Principal Investigator

Institut National de la Recherche Agronomique

Aix Marseille Université

Hôpital de la Conception

Neptune Krill Oil(TM)softgels (1g QD). Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.

Fish oil softgels (1g QD). Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.

Placebo (soy oil) softgels (1g QD. The soy oil placebo will provide neither EPA nor DHA.

Early Onset Alzheimer Disease

Softgels 1g QD. Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.

Neptune Krill Oil

Softgels 1g QD. Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.

Fish Oil

Softgels 1g QD. The soy oil placebo will provide neither EPA nor DHA.

lycopene/atrofia

Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia

Lycopene and Beta-carotene Metabolism in the Digestive Tract of Healthy Men

Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease (MNEMOSYNE)

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