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
hussien62@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Hussien Kadi
ORCID ID
https://orcid.org/0000-0002-2316-9429
Contact details
Yemen University
Sana'a
-
Yemen
+967 (0)711114951
hussien62@yahoo.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
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
Acronym
Study hypothesis
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).
Ethics approval
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, alahamdi.yem@gmail.com), ref: 12020
Study design
Randomized clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Influenza symptoms
Intervention
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.
Intervention type
Supplement
Phase
Drug names
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
01/02/2020
Overall trial end date
15/07/2020
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Total final enrolment
49
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2020
Recruitment end date
30/04/2020
Locations
Countries of recruitment
Yemen
Trial participating centre
Yemen University
Faculty of Medical Sciences
Sana'a
-
Yemen
Sponsor information
Organisation
Yemen University
Sponsor details
60 St.
Front of Sana’a University
Sana'a
-
Yemen
+967 (0)711114951
hussien62@yahoo.com
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 (hussien62@yahoo.com).
Intention to publish date
01/06/2020
Participant level data
Other
Basic results (scientific)
Publication list
2020 results in https://www.doi.org/10.46766/thegms.immuno.20062107 (added 20/07/2020)