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IRCT20170704034897N2 IRCT 2018-01-30 Shiraz University of Medical Sciences Efficacy of dried lime in common cold among Hajj pilgrims Preventive efficacy of dried lime (Citrus aurantifulia) in common cold among Hajj pilgrims: A randomized, double-blind placebo-controlled clinical trial 2014-09-10 anticipated 126 Complete https://irct.ir/trial/28781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: One hundred and twelve eligible patients were randomized into two parallel groups. A statistician generated a randomized list by using NCSS (statistical software) with simple block randomization method. All patients visited by a general practitioner and enrolled participants in the trial were assigned to drug or placebo group, according to randomization list, Blinding description: In this study, the participants, the general practitioner who visited the patients, the data collection authorities, those who evaluate the outcome, and Data Saftey and Monitoring Committee to assign study groups Were blind. But the main investigator was not blind to the study groups. Also, the author of the article had been blind at the end of the work too. N/A common cold. Intervention 1: Intervention group: Patients in drug group received dried lime capsules, 500 mg in a single dose per day for four weak. Test drug consisting of Citrus aurantifulia and sugar. The dried fruit of Citrus aurantifulia was purchased from the green market in Shiraz (Iran) and was authenticated by a botanist and was kept at the Herbarium of the Faculty of Pharmacy, Shiraz University of Medicinal Sciences, Shiraz, Iran. 500 milligram of the milled powder of dried fruit of Citrus aurantifulia and 50 milligrams of sugar as filler filled into a capsule. Intervention 2: Control group: In the placebo group, patients received placebo capsules with the same method.(a single dose per day for four weak) Placebo capsule, consisting of 550 milligrams of flour with identical size and shape to test drug. Yes - There is a plan to make this available What will be shared: Part of the individual information of the participants, such as information on the main outcome of the data in the study, is the possibility of sharing. This information includes some of the demographic characteristics and data related to the severity of a cough, rhinorrhea, body pain and fever. When: Start the access period 6 months after publishing the results for 1 month To whom: Only for researchers working in academic and scientific institutions Conditions: Only a descriptive survey of data is allowed. Where to obtain: By sending an email to the scientific responsible of the study, Dr. Pasalar, at the following address: pasalar@sums.ac.ir How to obtain: After the request has been sent, it will be answered within a maximum of 2 months. Comments:
public Dr. Seyed Hossein Owji
Shiraz Medical School, Imam Hossein Square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3212 2970 owji_h@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Mehdi Pasalar
Shiraz Medical School, Imam Hossein Square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3233 8476 pasalar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) All men and women aged 35 to 80 years participating in the Hajj who agree with the aim of the study 35 years 80 years Both participants who have asthma participants who have a chronic obstructive pulmonary disease participants who have uncontrolled heart diseases participants who have heart failure participants who have a hepatic and renal failure participants who have a history of previous chest surgery. J00 Acute nasopharyngitis [common cold] Treatment - Drugs Placebo Intervention group: Patients in drug group received dried lime capsules, 500 mg in a single dose per day for four weak. Test drug consisting of Citrus aurantifulia and sugar. The dried fruit of Citrus aurantifulia was purchased from the green market in Shiraz (Iran) and was authenticated by a botanist and was kept at the Herbarium of the Faculty of Pharmacy, Shiraz University of Medicinal Sciences, Shiraz, Iran. 500 milligram of the milled powder of dried fruit of Citrus aurantifulia and 50 milligrams of sugar as filler filled into a capsule. Control group: In the placebo group, patients received placebo capsules with the same method.(a single dose per day for four weak) Placebo capsule, consisting of 550 milligrams of flour with identical size and shape to test drug. The severity of a cough. Timepoint: First , second, third and fourth week after intervention. Method of measurement: By self-administered questionnaire that ranged from 0-5 scores (without symptoms to severe symptoms). The severity of rhinorrhea. Timepoint: First , second, third and fourth week after intervention. Method of measurement: By self-administered questionnaire that ranged from 0-5 scores (without symptoms to severe symptoms). The severity of fever. Timepoint: First , second, third and fourth week after intervention. Method of measurement: By self-administered questionnaire that ranged from 0-5 scores (without symptoms to severe symptoms). The severity of body pain. Timepoint: First , second, third and fourth week after intervention. Method of measurement: By self-administered questionnaire that ranged from 0-5 scores (without symptoms to severe symptoms). Shiraz University of Medical Sciences Approved 2014-05-01 Ethics committee of Shiraz University of medical sciences Shiraz University of medical sciences, Zand street, Shiraz Shiraz Fars Iran (Islamic Republic of)