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

Background and Objective: Hajj is one of the most important religious rituals among Muslims which is held in Mecca, Saudi Arabia annually. Viral respiratory infection is the most common communicable diseases among them. Dried lime (Citrus aurantifulia) is one of the herbal preparations that used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms. So we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims during the Hajj period. Materials and Methods: This trial was a randomized, double arm; parallel group, a double-blind clinical trial that was approved by Ethics Committee of Shiraz University of Medical Sciences and was registered at Iranian Registry of Clinical Trials (IRCT Id: IRCT20170704034897N2). Participating in the Hajj aged 35 to 80 years who agree with the aim of the study were included. Exclusion criteria were having a medical disease. Patients were randomly assigned to receive dried lime capsule (n = 60) as the drug group or placebo group (n = 52). Patients in drug group received dried lime capsules, 500 mg in a single dose per day for four weak. In the placebo group, patients received placebo capsules with the same method. Test drug consisting of Citrus aurantifulia and sugar. Placebo capsule, consisting flour with identical size and shape to test drug. Primary outcome measure in this trial was the severity of cold’ symptoms assessed by a self-administered questionnaire. The questionnaire evaluates a cough, rhinorrhea, fever, and body pain. Patients were randomized into two parallel groups with simple block randomization method. Data were described using descriptive statistics. Chi-square and two independent sample T-tests were used for statistical comparison of baseline characteristics. The p-value of less than 0.05 was considered significant. All data were analyzed using STATA version 11.2. Findings: 126 volunteers were assessed for eligibility. Sixty volunteers were assigned to the drug group and 52 volunteers to the placebo group. The mean age of participants was 54.50(±11.41) and 50.46(±10.26) years in drug and placebo groups, respectively (p =0.06). There were no significant differences between the two groups in term of the trend of cold’ symptoms severity during the study period. However, in the second week, the severity of all the cold’ symptoms in the drug group was less compared to placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The finding reveals that although the severity of all the cold’ symptoms in the drug group was less compared to placebo, the dried lime capsule has not statistically significant effect on control of these symptoms in Iranian pilgrims.

کلیدواژه ها:

Common Cold ، lime ، Islam ، Communicable Diseases