Assessing the effect of combination of Thyme, Oregano, Echinacea and Mallow flowers on the severity of cold and influenza symptoms

Assessing the effect of combination of Thyme, Oregano, Echinacea and Mallow flowers on the severity of cold and Influenza symptoms

َA randomized doble blined control trial, with paralel groups, randomized using random digit table on 80 participants (no=40 per group), assigned to intervention and placebo group

This double blinded study will be performed in Fayaz Bakhsh Hospital. At base line and 10 days of intervention with supplement/placebo the severity of rhinorrhea and nasal congestion, sneeze, and cough, using Visual Analog Scale (VAS) (10 score), and disease duration will be recorded

Inclusion criteria: age 18-65 years, having cold or influenza according to internist diagnosis, willing to participate in the study Exclusion criteria: using antibiotic, having diabetes, having known cardiovascular diseases, having known renal diseases, having any types of cancer, pregnancy, lactation, using corticosteroids, Using anti-rejection drugs

Patients will receive 750 mg Rocoldup capsule or placebo two times daily for 10 days. Each capsule contains Silybum marianum, Cichorium intybus L, Solanum nigrum and Urtica dioic extract or maltodextrine in placebo group.

Severity of rhinorrhea and nasal congestion, sneeze, and cough, using Visual Analog Scale (VAS) (10 score), and disease duration

Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 80 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling

It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code (supplement and placebo) at the time of sampling. The following groups of people: participants, research team including principle investigator, data collectors, and outcome assessors will be blind

All data could be available to public

Starting 6 months after publication

To all

No other criteria

Email to soodehrazeghi@gmail.com

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