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IRCT20150101020514N22 IRCT 2023-09-20 Pishgamane Eixire Sabze Arvand Co. Safety and efficacy of assessment of Alis collagen drink (containing 4 g hydrolyzed collagen) compared to a control collagen-free drink Safety and efficacy of assessment of Alis collagen drink (containing 4 g hydrolyzed collagen) compared to a control collagen-free drink for improvement of biophysical and ultrasonography skin parameters 2023-10-22 anticipated 30 Complete https://irct.ir/trial/72619 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by simple randomization using a blind card, In this way, the name of the formulation is written on the same cards. A card is selected randomly for each person, Blinding description: In case of assessor blinding, the randomization list is given to a third person. Assignment of the formulation to participants is made after receiving the code of randomization by researcher. Participant blindness performed packing products in similar containers with different numeric code. 2-3 skin aging. Intervention 1: Intervention group: daily consumption of 250 ml of Alis collagen supplement drink for 8 weeks, which includes: Spring water, hydrolyzed bovine collagen protein (food grade) 4g, acerola powder-vitamin A (0.0066 gr/lit), vitamin C (1 gram of acerola powder with 32% purity of vitamin C has been added in the formulation), vitamin E (0.75 gr/lit and hyaluronic acid (0.022gr). Intervention 2: Control group: daily consumption of 250 ml of collagen-free drink for 8 weeks, which includes: Spring water, acerola powder-vitamin A (0.0066 gr/lit), vitamin C (1 gram of acerola powder with 32% purity of vitamin C has been added in the formulation), vitamin E (0.75 gr/lit and hyaluronic acid (0.022gr). 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 information
public Aniseh Samadi
No. 415, Naderi Aven., Taleghani St.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 dermalab@tums.ac.ir Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Naderi Aven., Taleghani St.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 firozali@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Ages 35 to 55 Healthy people with skin type II to V Signing the consent form for participation in the study 35 years 55 years Both History of using RF, anti aging and intense pulsed light during the past 6 months .Active smoker in last 2 years Pregnancy or lactating Suffering from systemic diseases that affect skin health, such as vascular collagen diseases, diabetes, hypothyroidism, as well as liver and kidney failure. History of taking supplements containing collagen, hyaluronic acid and vitamin C in the last 3 months Treatment - Drugs N/A Intervention group: daily consumption of 250 ml of Alis collagen supplement drink for 8 weeks, which includes: Spring water, hydrolyzed bovine collagen protein (food grade) 4g, acerola powder-vitamin A (0.0066 gr/lit), vitamin C (1 gram of acerola powder with 32% purity of vitamin C has been added in the formulation), vitamin E (0.75 gr/lit and hyaluronic acid (0.022gr) Control group: daily consumption of 250 ml of collagen-free drink for 8 weeks, which includes: Spring water, acerola powder-vitamin A (0.0066 gr/lit), vitamin C (1 gram of acerola powder with 32% purity of vitamin C has been added in the formulation), vitamin E (0.75 gr/lit and hyaluronic acid (0.022gr) Skin elasticity. Timepoint: Before intervention , 4, 8 and 12 weeks after using. Method of measurement: Cutometery. Skin thickness and density. Timepoint: Before intervention ,4 , 8 and 12 weeks after using. Method of measurement: Skin ultrasound. Changes in stratum corneum hydration. Timepoint: Before intervention , 4, 8 and 12 weeks after using. Method of measurement: Corneometry. Pishgamane Eixire Sabze Arvand Co. Approved 2023-09-05 Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science Unit 1-219, 2nd floor, The Institute of Pharmaceutical Sciences, Faculty of Pharmacy, 16 Azar Avenue Tehran Tehran Iran (Islamic Republic of)