Preventive efficacy of dried lime (Citrus aurantifulia) in common cold among Hajj pilgrims: A randomized, double-blind placebo-controlled clinical trial

to evaluate the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims in a randomized, double-blind placebo-controlled clinical trial during Hajj period

In this research, 112 eligible patients were chosen purposefully and were randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participants.

Since travel of the Iranian pilgrims to Saudi Arabia last four weeks (two weeks in the city of Mecca and two weeks in the city of Medina), our study was conducted by the present time of pilgrims in these cities. General practitioner visited all patients and enrolled in the trial based on inclusion criteria. Group allocation was concealed by assigning a unique code to each participant. In this study, the participants, the general practitioner who visited the patients, the data collection authorities, those who evaluate the outcome, those who prepare the draft article, and Data Saftey and Monitoring Committee to assign study groups Were blind. But the main investigator was not blind to the study groups.

inclusion criteria: All men and women aged 35 to 80 years participating in the Hajj who agree with the aim of the study exclusion criteria: 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.

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, rhinorrhea, fever, and body pain that ranged from 0-5 scores (without manifestation to severe symptom).

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.

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.

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.

Start the access period 6 months after publishing the results for 1 month

Only for researchers working in academic and scientific institutions

Only a descriptive survey of data is allowed.

By sending an email to the scientific responsible of the study, Dr. Pasalar, at the following address: pasalar@sums.ac.ir

After the request has been sent, it will be answered within a maximum of 2 months.