Trials / Completed
CompletedNCT06188949
A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals
A Randomized, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Dietary Ingredient in Vitality & Metabolic Factors in Healthy Individuals
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Vedic Lifesciences Pvt. Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2024-02-02
- Primary completion
- 2024-09-12
- Completion
- 2024-09-12
- First posted
- 2024-01-03
- Last updated
- 2025-01-31
Locations
2 sites across 1 country: India
Source: ClinicalTrials.gov record NCT06188949. Inclusion in this directory is not an endorsement.