Clinical study to evaluate the efficacy of Multivitamin Tablet in healthy male subjects in terms of overall well being, energy, fatigue, mental alertness and memory.

A multicentric, double blind, randomized, placebo controlled clinical study to evaluate the efficacy of Multivitamin Tablet â??Health OKâ?? in healthy male subjects.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/06/043008

Enrollment

Registered

2022-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

None listed

Interventions

Intervention1: Health OK Tablet (Multivitamin, Multimineral, Amino Acids with Taurine & Ginseng Extract) : 1 tablet once in a day after meal with a glass of water for 12 Weeks Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male Subjects aged 30-55 years(both inclusive) and in good health . 2) Subjects in a sedentary occupation or doing little exercise. 3) Non-smokers 4) Subject not presently on supplementation with multivitamins or similar products.

Exclusion criteria

Exclusion criteria: 1) Subject having allergy to soya. 2) Subject currently taking the investigational productor another equivalent multivitamin.(any subject who report multivitamin use must be willing to have a washout for 4 weeks before participating, if not willing to do this they will be excluded. 3) Subject has epilepsy, a thyroid disorder, haemochromatosis or suffers from food allergies. (they must consult their doctor before taking part.) 4) Contraindications or hypersensitivity to the use of the test article or their component. 5) Subjects with history of head injury, diabetes, heart disease, nutritional or herbal allergy or intolerance, neurological, psychological or psychiatric disorder. 6) Subject having alcohol or drug dependence. 7) Subjects currently using of blood thinning medications.

Design outcomes

Primary

Measure	Time frame
To compare General Well-Being (change from baseline) [at baseline and 12 weeks treatment]-CHIPS Questionnaire .Timepoint: 12 weeks	—

Secondary

Measure	Time frame
1) Change in Laboratory Parameters from baseline (CBC, Fasting Glucose, Fasting Insulin, Plasma Lactate) 2)Change in immune/inflammatory response(change from baseline) â??IFN-gamma. 3) Change in oxidative stress markers (change from baseline) (malondialdehyde, superoxide dismutase and reduced glutathione) 4) Change in Energy and Fatigue. 5) Change in Mental Alertness-Bond and Lader VAS. 6) Change in Memory. 7) Cardiovascular reactivity- Blood pressure and Heart rate (change from baseline). 8) Rate of infection during study.Timepoint: 12 weeks	—

Measure

Time frame

1) Change in Laboratory Parameters from baseline (CBC, Fasting Glucose, Fasting Insulin, Plasma Lactate) 2)Change in immune/inflammatory response(change from baseline) â??IFN-gamma. 3) Change in oxidative stress markers (change from baseline) (malondialdehyde, superoxide dismutase and reduced glutathione) 4) Change in Energy and Fatigue. 5) Change in Mental Alertness-Bond and Lader VAS. 6) Change in Memory. 7) Cardiovascular reactivity- Blood pressure and Heart rate (change from baseline). 8) Rate of infection during study.Timepoint: 12 weeks

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Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Service

milansatia@ethicare-cro.com9825585119

Outcome results