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IRCT20200418047125N1 IRCT 2021-08-06 Mashhad University of Medical Sciences The effect of coconut oil consumption on improving the weakness of COVID-19 patients Evaluation the Effect of Coconut Oil as a complementary therapy on fatigue in Covid-19 patients A randomized double-blind pilot study 2021-05-22 anticipated 28 Complete https://irct.ir/trial/56282 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization will be performed by simple randomization method using random numbers derived from Excel program. First, the total sample size and number of groups are entered into the software. The software output includes a list that randomly assigns patients to two groups A (intervention) and B (control). Patients are distributed according to the time of referral according to the list of the mentioned group until the end of sampling. Random sequence generation in Excel software is done using the RANDBETWEEN () function According to this method, each of the cells is randomly assigned a code of 0 or 1. Cells with code 0 belong to the intervention group and cells with code 1 belong to the control group. Patients are assigned to one of the groups according to the generated list, Blinding description: This study is performed as a double-blind study. The researcher and the patients participating in the study are unaware of the content of the drug. Drugs are prepared and coded in similar packages and provided to the executor for the prescription to patients. The outcome assessment is done by a person who is blind to the allocation process. 2 COVID- 19. Intervention 1: Intervention group: In addition to routine treatment, 30 cc (every 12 hours 15 cc) of virgin coconut oil is consumed orally in pure form or with milk or soup. Routine treatment includes acetaminophen 500 mg tablets every 8 In case of pain or fever, take one vitamin 1000 microgram tablet daily and recommend rest, proper nutrition, and adequate fluid intake. Intervention 2: Control group: In addition to routine treatment, patients in the control group consume 30 cc (15 cc every 12 hours) of placebo solution (containing mineral water + coconut flavoring) in pure form or with milk or soup.Routine treatment includes acetaminophen 500 mg tablets every 8 In case of pain or fever, take one vitamin 1000 microgram tablet daily and recommend rest, proper nutrition, and adequate fluid intake. Yes - There is a plan to make this available What will be shared: Information and data on the primary and secondary outcomes of patients will be shared after being identified. When: Ability to access data about 6 months after printing the results To whom: All researchers will be allowed access to the data after reviewing it by the person in charge of the study. Conditions: Any analysis of the data will be possible only with the permission of the corresponding author Where to obtain: corresponding Author How to obtain: The person submits their request, the corresponding author evaluates the accessibility and if possible the access to the data will be granted. Comments:
public Ghazaleh Ghorbannezhad
No. 4, Emad khorasani 7, piroozi 72, piroozi Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9179973148 +98 51 3891 8263 ghorbannezhadg962@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Ali Reza Derakhshan
Mashhad, University of Medical Sciences, Faculty of Iranian and Complementary Medicine
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8931 Derakhshanar@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients 18-80 years old have been diagnosed COVID-19, According to the information registration system of Mashhad University of Medical Sciences hospitalized at home 18 years 80 years Both History of Allergy to coconut and its derivatives Dissatisfaction with inclusion in the study Severe illness and need for hospitalization U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: In addition to routine treatment, 30 cc (every 12 hours 15 cc) of virgin coconut oil is consumed orally in pure form or with milk or soup. Routine treatment includes acetaminophen 500 mg tablets every 8 In case of pain or fever, take one vitamin 1000 microgram tablet daily and recommend rest, proper nutrition, and adequate fluid intake. Control group: In addition to routine treatment, patients in the control group consume 30 cc (15 cc every 12 hours) of placebo solution (containing mineral water + coconut flavoring) in pure form or with milk or soup.Routine treatment includes acetaminophen 500 mg tablets every 8 In case of pain or fever, take one vitamin 1000 microgram tablet daily and recommend rest, proper nutrition, and adequate fluid intake. Weakness. Timepoint: End of the first and second week. Method of measurement: According to the VAS criteria. Fever. Timepoint: At the end of the first and second week. Method of measurement: Thermometer. Intensity and frequency of cough. Timepoint: At the end of the first and second week. Method of measurement: Visual Scale Scoring or VAS. Myalgia. Timepoint: At the end of the first and second week. Method of measurement: Visual Scale Scoring or VAS. Respiratory rate. Timepoint: At the end of the first and second week. Method of measurement: count respiratory rate in one minute. Hospitalization. Timepoint: At the end of the first and second week. Method of measurement: The ratio of the number of cases leading to hospitalization to the total number of patients in each group. Mashhad University of Medical Sciences Approved 2021-04-24 Ethics committee of Mashhad University of Medical Sciences School of Medicine, Mashhad University of Medical Sciences,Vakilabad St., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)