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

A single centric open label interventional clinical trial to evaluate the immunomodulatory effect of Kuka immunity booster tablets on healthy volunteers.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026743

Enrollment

Registered

2020-07-22

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Kuka Immunity booster tablets: Dose: Age- 10-18 yrs- 1 tablet before meal with 1 cup (150-180 ml) of lukewarm water for 30 days 19-60 yrs- 2 tablets BD before meal with 1 cup (150-180 m

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the changes in levels of Th1 and Th 2 cytokines (interferon Î³ and interleukin-4)Timepoint: Baseline (day 0), Day 30	—

Secondary

Measure	Time frame
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). 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). Timepoint: Baseline (Day 0), Day 30	—

Countries

India

Contacts

Public ContactDr Himanshu S Tiwari

Multani Pharmaceutical Ltd.

dr.hstiwari@multani.org9654350714

Outcome results