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IRCT20210906052391N1 IRCT 2021-11-29 Iran University of Medical Sciences licorice in hoarseness Evaluation of the effect of licorice-based lozenge on hoarseness/dysphonia 2018-09-23 anticipated 80 Complete https://irct.ir/trial/58819 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization by shuffling cards In such a way that; 40 cards are considered as the experimental group with the letter B and the same number of cards for the control group with the letter A; Then, by shuffling the cards, a card is taken out and its allocation is recorded. Then the cards are dealt again and another card is taken out. This process continues until a random sequence is reached according to the sample size, Blinding description: The intervention group will receive 4 tablets containing one gram of licorice extract daily for two weeks; and the control group will receive the placebo, which is completely similar to the herbal product in terms of color, appearance, taste and size, for two weeks with the same number and conditions. 3 Hoarseness. Intervention 1: Intervention group: The intervention group takes 4 lozenges one after another in one meal every day. Without consuming it with water or food. The duration of use is 14 days. Each tablet contains 250 mg of licorice extract, so the total consumption of licorice extract will be one gram per day. This drug has been prepared as a pilot research in collaboration with Touba Green Gold Institute in the tablet factory. Intervention 2: Control group: The control group takes 4 placebo lozenges one after the other in one meal every day. Without consuming it with water or food. The duration of use is 14 days. Yes - There is a plan to make this available What will be shared: All data related to biographical information and self-reported scores of patients can be shared with the potential voice disability questionnaire after identifying individuals. When: 6months after the publication of the results To whom: Everyone can access the data Conditions: There are no other special conditions for accessing the documents Where to obtain: Applicants for correspondence can contact Dr. Mostafa Solati via the following email address. Solati.Mostafa@yahoo.com How to obtain: After sending the request via email, the request will be reviewed and answered within a week or so Comments:
public Mostafa Solati
Faculty of Iranian Medicine, Behesht St., Islamic Vahdat St.
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5558 0388 Solati.Mostafa@yahoo.com Iran University of Medical Sciences scientific Mostafa Solati
Faculty of Iranian Medicine, Behesht St., Islamic Vahdat St.
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5558 0388 Solati.Mostafa@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Having a clinical diagnosis of hoarseness Despite conventional medical treatment, there is no satisfactory recovery No previous diagnosis of laryngeal mass and malignancy Absence history of chronic diseases in which licorice is contraindicated Do not take drugs that seriously interfere with licorice 18 years 55 days Both Diagnosis of mass and malignancy or factors suspected of laryngeal malignancy Taking drugs that seriously interfere with licorice Presence of hypertension, heart disease with edema, kidney and liver diseases Pregnancy Smoking Hypersensitivity to licorice R49.0 Dysphonia Abductor dysphonia; Chronic hoarseness; Difficulty speaking; Dysphonia, abductor; Hoarse; Hoarseness; Hoarseness, chronic; Plica dysphonia ventricularis; Ventricular dysphonia; Voice disorder, dysphonia; Hoarseness Treatment - Drugs Treatment - Drugs Intervention group: The intervention group takes 4 lozenges one after another in one meal every day. Without consuming it with water or food. The duration of use is 14 days. Each tablet contains 250 mg of licorice extract, so the total consumption of licorice extract will be one gram per day. This drug has been prepared as a pilot research in collaboration with Touba Green Gold Institute in the tablet factory Control group: The control group takes 4 placebo lozenges one after the other in one meal every day. Without consuming it with water or food. The duration of use is 14 days The effect of hoarseness on daily life, before the intervention. Timepoint: At the beginning of the study, before the intervention. Method of measurement: Mean score of quality of life using voice disability index (VHI) questionnaire before intervention. The degree of change in hoarseness and its effect on daily life after the intervention. Timepoint: 14 days after the intervention. Method of measurement: Mean score of quality of life using vocal disability index (VHI) questionnaire after intervention. Iran University of Medical Sciences Approved 2018-06-24 Ethics Committee of Iran University of Medical Sciences Faculty of Iranian Medicine, Intersection of Hafez St. with Behesht St Tehran Tehran Iran (Islamic Republic of)