Clinical evaluation for Efficacy of Kuka immunity booster tablets in improving immunity.

Phase 2

Completed

• Registration Number: CTRI/2020/07/026743
• Lead Sponsor: Multani Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-21
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

1.Apparently healthy subjects of either gender between the age group of 10 years to 60 years (both inclusive). Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring and treatment.

2.Subjects aged between 10 to 60 years of either sex not taking any medicine will be included in the study.

3.Subjects willing to give informed consent for the study. Consent for child will be taken from his/her parents or guardian.

4.Subject devoid of any medication during last one month.

Exclusion Criteria

1. Individuals with immediate life threatening diseases such as preexisting cardiovascular, liver, or neoplastic diseases or who received any immunosuppressant, sedative, hypnotic or tranquilizer within 30 days prior to enrollment.

2. Individuals with any psychiatric illness which may impair the ability to provide written ICF.

3. Individuals participating in any other clinical trial.

4. Pregnant or lactating females.

5. Subjects suffering from different diseases/disorders and/or undergone surgery during last one year, received organ transplant, chronic smokers, underlying conditions which might affect immunity.

6. Alcohol and drug abusers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the changes in levels of Th1 and Th 2 cytokines (interferon γ and interleukin-4)Timepoint: Baseline (day 0), Day 30

Secondary Outcome Measures

Name	Time	Method
1. Assessment of changes in rest blood investigations like IgG, IgM, IgA, IgE, CBC, ESR etc at baseline (Day 0) to the end of the therapy (day 30). <br/ ><br>2. Assessment of changes in subjective parameters like Anorexia, Bala, physical health, immunity status and Vyadhikshmatva index at baseline (day 0) and end of therapy (day 30). <br/ ><br>Timepoint: Baseline (Day 0), Day 30