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

• Register: ISRCTN
• Last refreshed on: 11 January 2021
• Main ID: ISRCTN49673328
• Date of registration: 29/12/2020
• Prospective Registration: No
• Primary sponsor: Yemen University
• Public title: 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
• 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
• Date of first enrolment: 01/04/2020
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN49673328
• Study type: Interventional
• Study design: Randomized clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Yemen

Contacts

• Name: Hussien Kadi

Key inclusion & exclusion criteria

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

Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza symptoms
Infections and Infestations

Intervention(s)

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(s)

Flu symptoms assessed using improving health scale (0-5) before and 3 and 7 days after treatment

Secondary Outcome(s)

There are no secondary outcome measures

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Approved 15/3/2020, Ethics Committee of Yemen University, Faculty of Medical Sciences (60 St. Yemen University, Faculty of Medical Sciences, Sana'a, Yemen; [phone], [e-mail]), ref: 12020

Results

• Date Completed: 15/07/2020