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IRCT20230808059082N1 IRCT 2024-02-24 Tehran University of Medical Sciences Effect of Lotion of Myrtus communts and Phyllanthus emblica on the Androgenic Alopecia Evaluation of the Effect of Topical Lotion of Myrtus communts and Phyllanthus emblica on the Androgenic Alopecia in Women: A Clinical Trial Study 2024-04-20 anticipated 120 Recruiting https://irct.ir/trial/71939 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomly assigned treatments to the patients will be accomplished using R software by statistics specialist .Thus statistics specialist allocated randomized codes by "R software" to study groups so patients, investigator and analyzer are blinded(triple blinded), Blinding description: Blinding: Patients, researchers and analysts will not be informed of the random assignment of groups until the end of the study. Coding and also the pharmaceutical packaging for all groups is uniform, and the contents of the containers are similar in terms of consistency and color. At the end of the study, the desired code for grouping, which is inserted on the drug package, will be decoded to match the information and analyze the data. 3 Androgenic alopecia. Intervention groups: 4 including group 1: Iranian traditional medicine lotion based on Mirtica, group 2: traditional medicine lotion based on Amla, group 3: herbal product lotion based on the combination of Mirtica and Amla, and finally group 4: placebo lotion.. No - There is not a plan to make this available Justification or reason for not sharing IPD is For ethical reasons
public Farzaneh Maftoon
Ahmadieh salamtkadeh, Sarparast str.,Talaghani str.
Tehran Iran (Islamic Republic of) 1417613151َ +98 912 326 2644 fmaftoon5@gmail.com Tehran University of Medical Sciences scientific Farzaneh Maftoon
Ahmadieh salamtkadeh, Sarparast str.,Talaghani str.
Tehran Iran (Islamic Republic of) 1417613151َ +98 912 326 2644 fmaftoon5@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Females in the pre-menopausal period complaining of hair loss Patient consent to participate and fill out the informed consent form. 18 years 60 years Female History of allergic response/hypersensitivity to any ingredients and pharmaceutical products. History of thyroid disorder, diabetes mellitus, polycystic ovary syndrome Subjects under medical treatment for hair problems, consuming drugs (such as minoxidil, finasteride, platelet rich plasma or Biotin) and laser therapy in the 2 months prior to the study Subjects under medical treatment for hair problems with 5 α-reductase inhibitors. Subjects under medical treatment with antiandrogenic agents (such as spironolactone, cimetidine and cyproterone acetate) in the 2 months prior to the study Subjects consuming systemic corticosteroid therapy for more than 14 days in the 2 months prior to the study Any active scalp disease in the 6 months prior to the study Any history of cancer or autoimmune diseases History of hair transplant Pregnancy or Brest - feeding History of serious acute illness in the 2 months prior to the study L64 Androgenic alopecia Treatment - Drugs Intervention groups: 4 including group 1: Iranian traditional medicine lotion based on Mirtica, group 2: traditional medicine lotion based on Amla, group 3: herbal product lotion based on the combination of Mirtica and Amla, and finally group 4: placebo lotion. Hair count (number of hairs in 0.7 cm2). Timepoint: Week 8, week 16. Method of measurement: Trichoscan method. Hair density (number of hairs in cm2). Timepoint: Week 8, week 16. Method of measurement: Trichoscan method. Hair diameter. Timepoint: Week 8, week 16. Method of measurement: Trichoscan method. Ratio of anagen to telogen. Timepoint: week8, week16. Method of measurement: Trichoscan method. Dandruff. Timepoint: Before and after study (week1, week16). Method of measurement: Patient view assessment (5 Likert). Greasy hair. Timepoint: Before and after study (week1, week16). Method of measurement: Patient view assessment(5 Likert). Tehran University of Medical Sciences Approved 2023-07-17 Ethics committee of Tehran University of Medical Sciences Headquarters Building, Ghods street corner, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)