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IRCT20191103045318N1 IRCT 2020-01-13 Tehran University of Medical Sciences Effectiveness of Iranian Medicine Product: Tamarrindus Indica L. Syrup (Somalax) on Patients with Acne. Effectiveness of Iranian Medicine Product: Tamarrindus Indica L. Syrup (Somalax) Compared to Placebo on Patients with Mild to Moderate Acne: A Triple_Blind Randomized Clinical Trial 2019-11-22 anticipated 110 Complete https://irct.ir/trial/43415 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization, Blinding description: This study presents drugs and placebo in similar packaging. The only difference is the mark A and B on the packaging The manufacturer knows which symptom is related to the drug and which placebo Participants do not know whether they are taking medication or placebo The researcher does not know if she is taking medication or placebo DSMB is not aware of the type of intervention. 3 Acne. Intervention 1: Intervention group:Iranian medicine product, Somalax syrup (83.3 mg per hl, yellow herb 41.7 mg, jujube 8.20 mg, floss 8.20 mg, red sugar 8.50 mg, Indian spice 5.62 mg) Grams, vinegar 41.7 mg, honey 150 mg), 10 cc each 8 hours for 12 weeks at the laboratory of the Faculty of Pharmacy, University of Tehran. Intervention 2: Control group: To make the placebo, mix the water with enough sugar and heat to a consistency, then add turmeric and brown edible oils.Dosage: 10 cc every 8 hours, for 12 weeks, Faculty of Pharmacy, University of Tehran. Yes - There is a plan to make this available What will be shared: All potential participant data is shared after unidentifiable individuals When: 6 months after printing the results To whom: The data will be available to researchers working in academia and in the industry and can apply for it. Conditions: For scientific studies Where to obtain: Razieh Kasraie Email: dr.kasraei@yahoo.com Phone Number: 09178932624 How to obtain: After reviewing the applicant's request and making sure the data is used for scientific studies, the identifiable data of the study participants will be made available to the applicant. Comments:
public Razieh Kasraei
No.4, 6th alley, Hormozan Ave., Qods (Gharb) Town
Tehran Iran (Islamic Republic of) 1466614143 +98 21 8809 9869 dr.kasraei@yahoo.com Tehran University of Medical Sciences scientific Razieh Kasraei
No.4, 6th alley, Hormozan Ave., Qods (Gharb) Town
Tehran Iran (Islamic Republic of) 1466614141 +98 21 8809 9869 dr.kasraei@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Mild to moderate acne on the face Lack of a history of systemic disease when the patient has to take systemic medication No use of inducing or reducing acne medications in the last 2 weeks No facial surgery in the last month No pregnancy and no breast feeding Willingness to participate in the study 18 years no limit Both L70.9 Acne, unspecified Treatment - Drugs Placebo Intervention group:Iranian medicine product, Somalax syrup (83.3 mg per hl, yellow herb 41.7 mg, jujube 8.20 mg, floss 8.20 mg, red sugar 8.50 mg, Indian spice 5.62 mg) Grams, vinegar 41.7 mg, honey 150 mg), 10 cc each 8 hours for 12 weeks at the laboratory of the Faculty of Pharmacy, University of Tehran Control group: To make the placebo, mix the water with enough sugar and heat to a consistency, then add turmeric and brown edible oils.Dosage: 10 cc every 8 hours, for 12 weeks, Faculty of Pharmacy, University of Tehran Acne severity index. Timepoint: At baseline (before intervention) and at 6, 12, and 16 weeks after drug administration. Method of measurement: The lesion is counted by the researcher and placed in the ASI formula. Quality of life score. Timepoint: At baseline (before intervention) and 16 weeks after drug administration. Method of measurement: DLQI Quality of Life Questionnaire. Tehran University of Medical Sciences Approved 2018-10-29 Ethics committe of Tehran University of Medical Sciences No. 16, 6th Tower, Sina alley, Iranzamin Blvd., Gharb(Qods) Town Tehran Tehran Iran (Islamic Republic of)