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A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals

NCT06188949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-01-31

No results posted yet for this study

Summary

The present study is a randomized, placebo-controlled, feasibility study to evaluate efficacy of dietary ingredients in vitality \& metabolic factors in healthy individuals. Approximately 54 subjects aged between ≥ 40 and ≤ 60 years will be screened and 36 participants (12 in each arm) are to be randomized. Both the IP and placebo study arms will have 10 completed subjects in each arm after accounting for the screening failure and dropout/withdrawal rate of 30% and 17% respectively (Total 30 completers). The treatment duration for all the study subjects will be 90 days.

Conditions

  • Aging

Interventions

DIETARY_SUPPLEMENT

Dolichos biflorus (Horsegram) seed extract

1 capsule twice a day (Before breakfast \& dinner)

DIETARY_SUPPLEMENT

Carica papaya leaves extract

1 capsule twice a day (Before breakfast \& dinner)

DIETARY_SUPPLEMENT

Placebo (MCC)

1 capsule twice a day (Before breakfast \& dinner)

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2024-09-12
Completion
2024-09-12

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188949 on ClinicalTrials.gov