The effects of IMMUTONIC capsule oral three times daily for 1 week on volunteers with flu symptoms, their blood immune parameters and CD4 T-cells
| ISRCTN | ISRCTN49673328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49673328 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Yemen University |
| Funder | Investigator initiated and funded |
- Submission date
- 17/07/2020
- Registration date
- 29/12/2020
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Yemen University
Sana'a
-
Yemen
 ORCID ID |
0000-0002-2316-9429 |
|---|---|
| Phone | +967 (0)711114951 |
| hussien62@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Flu symptoms assessed using improving health scale (0-5) before and 3 and 7 days after treatment |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 15/07/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 49 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2020 |
| Date of final enrolment | 30/04/2020 |
Locations
Countries of recruitment
- Yemen
Study participating centre
Sana'a
-
Yemen
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/06/2020 | 20/07/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/08/2020: Trial's existence confirmed by Yemen University.
