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IRCT20150101020514N10 IRCT 2021-01-14 Jarf Anishan Navid Salamat company Evaluation the effect of jujube fruit on skin hyperpigmentation Evaluation the effect of Jujube fruit (Ziziphus jujuba L) on skin hyperpigmentation comparison to placebo control; a double blind randomized clinical trial 2020-09-28 anticipated 46 Complete https://irct.ir/trial/51332 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Chain Generation performed using by R-CRAN version 3.2.3. Using random permutation blocks will be made blocks (the size of each block is 4) for a total of 46volunteers (1: 1 ratio). The codes will be labeled on the drugs. After ensuring the volunteer's eligibility and signing the informed consent form, a nurse will receive a code from the study site which will be used for random allocation of the drug to the candidate. The related drug will be given for the volunteer. In this way, the volunteers fall into one of the two intervention groups and the volunteers' group and the type of drug they receive will not be disclosed to researchers or the study team, Blinding description: In this study, the main researcher is responsible for taking photo from visioface device. In order to keep blinding study, volunteers receive drug by one of staff according to random numbers table. Stuff give the same explanations to each of the volunteers. 3 hyperpigmentation. Intervention 1: 1: Intervention group: jujube syrup, 1 tablespoon (7.5 cc), twice a day, 8 weeks. Intervention 2: Control group: 1 tablespoon (7.5 cc), twice a day, 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more data
public Ensiye Aafi
No. 24 and 26, 6th Alley (Shahid Rahmati Bahmbari)., Valiasr Square., Tehran
Tehran Iran (Islamic Republic of) 1594733711 +98 21 8889 6836 ensiye_affi@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
Corner of Naderi St., Shahid Taleghani St., Tehran
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 Firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Skin Type (III -IV) Aged between 18 to 60 years Signed informed consent voluntarily and knowingly 18 years 60 years Both Use any light sensitive drug within 3 months prior to the study Active skin disease at test area: rosacea, atrophy, acne, eczema Use of topical lightening products like AHA ,BHA and retinoid components within 21 days prior to the study Documented allergies to components of test product Use of contraceptive or any hormonal drugs History of laser treatment or dermabrasion or deep facial peels within the past 3 months difficulty swallowing (a condition that could impact digestion and/or absorption) Active smoker ( last 1 years) Current pregnancy/ breast feeding Systemic disease (diabetics, hepatic disease, uncontrolled hypothyroidism) L81.4 Other melanin hyperpigmentation Treatment - Drugs Treatment - Drugs 1: Intervention group: jujube syrup, 1 tablespoon (7.5 cc), twice a day, 8 weeks Control group: 1 tablespoon (7.5 cc), twice a day, 8 weeks The numbers of skin spots, its size and percentage. Timepoint: At the beginning and after 8 weeks. Method of measurement: Visioface device. Jarf Anishan Navid Salamat company Approved 2020-09-21 Ethics committee of Tehran University of Medical Sciences First Floor., School of Medicine., Building No., 1 North Door of Tehran University., Poursina St. Tehran Tehran Iran (Islamic Republic of)