Condition category
Infections and Infestations
Date applied
17/07/2020
Date assigned
29/12/2020
Last edited
29/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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)

Publication citations

Additional files

Editorial Notes

13/08/2020: Trial's existence confirmed by Yemen University.