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IRCT20240218061044N1 IRCT 2024-04-29 Tehran University of Medical Sciences Efficacy and safety of GernaHair Premium on hair loss Safety and efficacy of "GernaHair Premium" supplement on Telogen Effluvium hair loss: A triple-blind, randomized, placebo-controlled clinical trial 2024-04-20 anticipated 57 Complete https://irct.ir/trial/75566 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the block randomization method, patients are divided into three groups A, B, and C, where group A receives 3 Geranahir daily, group B receives 1 Geranahir daily, and group C receives placebo. A random numbers table is used to prepare a random list. If the generated number is between 0 and 2, the patient receives group A treatment, if it is between 3 and 5, the patient receives group B treatment, and if it is between 6 and 8, the patient receives placebo. According to the output of the Random Allocation Software, each patient has a special code that Determines which medicine they receive, Blinding description: Gernahair premium boxes, one group of which contains the active substance and the other one contains the placebo, are prepared in a completely similar way to each other, and are randomly delivered to patients. The patient, the dermatologist, and the data analyzer are unaware of the type of treatment they are receiving also, the participants are unaware of the presence of other study groups and do not know that the number of GernaHair received in one day is different for every group. N/A Telogen Effluvium. Intervention 1: Intervention group number 1: This group will take 3 Gernahair Premium capsules orally for 6 months. This supplement contains 90 mg thiamine, 180 mg calcium pantothenate, 300 mg medicinal yeast, 60 mg L-cystine, 60 mg keratin, and 60 mg PABA per 3 capsules. Intervention 2: Intervention group number 2 : This group will take 1 Gernahair Premium capsules orally for 6 months. This supplement contains 30 mg thiamine, 60 mg calcium pantothenate, 100 mg medicinal yeast, 20 mg L-cystine, 20 mg keratin, and 20 mg PABA per 1 capsules. Intervention 3: Control group: This group will receive 3 placebo capsules daily for 6 months that contain microcrystalline cellulose. 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 further information
public Maryam Nasimi
Razi Hospital , Vahdate-e-eslami St , Tehran , Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5561 8989 m-nasimi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Maryam Nasimi
Razi Hospital , Vahdate-e-eslami St , Tehran , Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5561 8989 m-nasimi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with a history of hair loss who had clinical findings of female pattern hair loss (FPHL) Ludwig type II or I and parietal center telogen hair rate of more than 20%, as determined by TrichoScan Patients with diffuse hair loss without any evidence of underlying disease in medical history Patients with acquired or age-related damage to the hair structure, including thinning, brittle, or split end hair Patients with nail growth disorders such as soft or brittle nails with no evidence of underlying disease in the medical history 12 years no limit Both Symptomatic diffuse alopecia (eg, due to iron deficiency or thyroid disorder) FPHL Ludwig type III Androgenic alopecia with or without virile symptoms as a result of polycystic ovaries, late-onset adrenogenital syndrome and ovarian, adrenal, or pituitary tumors Systemic autoimmune diseases Debilitating diseases (eg, AIDS or malignancy) Alopecia Areata Inflammatory ulcer or other ulcerative alopecia Other inflammatory conditions affecting the scalp (such as seborrheic dermatitis, psoriasis, or contact dermatitis) Receiving any treatment for hair loss or participating in another clinical trial for 3 months before entering the study Receiving medications that may cause hair loss (such as anticoagulants, lipid-lowering drugs, retinoids, antiepileptic drugs, antithyroid drugs, androgens, progesterones with androgenic or relative toxic effects, Angiotensin Converting Enzyme inhibitors(ACE) ) within 3 months before entering the study. Receiving drugs containing sulfonamides (interference with PABA) Initiation or termination of hormone replacement therapy or hormonal contraception within 6 months before entering the study Any type of hormone replacement therapy or oral contraceptive containing progesterone with an androgenic effect (such as Norethisterone, Norgestrel, levonorgestrel, Linsternol or Tibolone) Pregnancy or breastfeeding Known sensitivity to any of components L65.0 Telogen effluvium Treatment - Other Treatment - Other Placebo Intervention group number 1: This group will take 3 Gernahair Premium capsules orally for 6 months. This supplement contains 90 mg thiamine, 180 mg calcium pantothenate, 300 mg medicinal yeast, 60 mg L-cystine, 60 mg keratin, and 60 mg PABA per 3 capsules. Intervention group number 2 : This group will take 1 Gernahair Premium capsules orally for 6 months. This supplement contains 30 mg thiamine, 60 mg calcium pantothenate, 100 mg medicinal yeast, 20 mg L-cystine, 20 mg keratin, and 20 mg PABA per 1 capsules. Control group: This group will receive 3 placebo capsules daily for 6 months that contain microcrystalline cellulose. Anagen hair rate. Timepoint: Before treatment, after 3 and 6 months of treatment. Method of measurement: Measuring the anagen hair rate in an area equal to 1.8 square centimeters in the center of the parietal of the scalp, while imaging the specific area and using the Trichoscan software. Hair count. Timepoint: Before treatment, after 3 and 6 months of treatment. Method of measurement: Measuring the hair count in an area equal to 1.8 square centimeters in the center of the parietal of the scalp, while imaging the specific area and using the Trichoscan software. Hair density. Timepoint: Before treatment, after 3 and 6 months of treatment. Method of measurement: Measuring the hair density in an area equal to 1.8 square centimeters in the center of the parietal of the scalp, while imaging the specific area and using the Trichoscan software. Cumulative hair shaft diameter. Timepoint: Before treatment, after 3 and 6 months of treatment. Method of measurement: Measuring the cumulative hair shaft diameter in an area equal to 1.8 square centimeters in the center of the parietal of the scalp, while imaging the specific area and using the Trichoscan software. Participant's satisfaction with treatment. Timepoint: Before treatment, after 3 and 6 months of treatment. Method of measurement: The patient's overall satisfaction with the treatment will be evaluated from 0 to 100 so that 0 is a sign of absolute dissatisfaction and 100 is a sign of maximum consumer satisfaction. Tose-e Teb Adrian Salamat co. Approved 2024-02-04 Ethics committee of Tehran University of Medical Sciences Central Administration Building, University of Tehran, Qods Ave., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)