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.

Phase 4

Completed

• Registration Number: CTRI/2022/06/043008
• Lead Sponsor: Mankind Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-19
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 89

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare General Well-Being (change from baseline) [at baseline and <br/ ><br>12 weeks treatment]-CHIPS Questionnaire .Timepoint: 12 weeks

Secondary Outcome Measures

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