Plain English Summary
Background and study aims
Many herbs and natural foods have been historically recognized as having an effective anti-inflammatory response and promoting a healthy immune response as well as having antibacterial and antiviral effects. The clinical use of some medications can cause serious side effects. The researchers propose that natural ingredients could serve as a better treatment approach. This study aims to evaluate the effect of IMMUTONIC capsules in human volunteers with flu symptoms.
Who can participate?
Men and women aged between 21 and 60 with flu symptoms
What does the study involve?
Volunteers take IMMUTONIC capsule three times daily after meals for 1 week. Flu symptoms are assessed after 3 days and 7 days. Blood samples are taken before and after taking the IMMUTONIC capsule.
What are the possible benefits and risks of participating?
The possible benefits include improved health and boosted immunity. There are no risks of participating.
Where is the study run from?
Yemen University (Yemen)
When is the study starting and how long is it expected to run for?
February 2020 to July 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Dr Hussien O. Kadi
The effects of IMMUTONIC capsule oral three times daily for 1 week on volunteers with influenza symptoms, their blood immune parameters and CD4 T-lymphocytes: a randomized clinical trial
The hypothesis of new formulation of IMMUTONIC capsule contain mixture of six natural food materials/ingredients with different amounts for each one which was done by Prof. Dr. Hussien O. Kadi (Patent).
Approved 15/3/2020, Ethics Committee of Yemen University, Faculty of Medical Sciences (60 St. Yemen University, Faculty of Medical Sciences, Sana'a, Yemen; +967 (0)771211157, firstname.lastname@example.org), ref: 12020
Randomized clinical trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Twenty-four male and female adult volunteers, aged between 21 and 60 years are selected for the study. The volunteers are free from significant cardiac, hepatic, renal, pulmonary, gastrointestinal, neurological or hematological disease as determined by way of medical histories, physical examinations. Volunteers take an IMMUTONIC capsule three times daily after meals for 1 week. Flu symptoms are measured at follow up after 3 days and 7 days using improving health scale 0-5.
Primary outcome measure
Flu symptoms assessed using improving health scale (0-5) before and 3 and 7 days after treatment
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Male and female adult volunteers, aged between 21 and 60 years, with flu symptoms
2. Free from significant cardiac, hepatic, renal, pulmonary, gastrointestinal, neurological or hematological disease as determined by way of medical histories, physical examinations
Target number of participants
Total final enrolment
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Faculty of Medical Sciences
Front of Sana’a University
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The results have been published (see publications list).
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication and are available from Prof. Dr Hussien O. Kadi (email@example.com).
Intention to publish date
Participant level data
Basic results (scientific)
2020 results in https://www.doi.org/10.46766/thegms.immuno.20062107 (added 20/07/2020)