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Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3)

NCT04228640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-04-01

No results posted yet for this study

Summary

This will be a multi-center, two arm study in 66 healthy adults. Subjects will complete a screening visit (V1, Day -7) to determine eligibility for the study based on Inclusion \& Exclusion Criteria, patient history and safety measures. Eligibility confirmation will be done on visit 2 (Day 1). Patients successfully completing screen will be assigned to either of the two treatments. Subjects will receive the treatment for at-home use and will also be given diaries for recording information of medication, and adverse events. At 2 different intervals i.e. Day 30 and Day 60 (V3, V4) subjects will return to the clinic to review and collect patient diaries, safety data and medication reconciliation. Efficacy and safety assessments will be done at baseline, Day 30 and Day 60 .

Conditions

  • Aging

Interventions

OTHER

NMN

Investigational Product

OTHER

Placebo

Starch Powder

Sponsors & Collaborators

  • ProRelix Research

    collaborator INDUSTRY

  • EffePharm LTD

    lead INDUSTRY

Principal Investigators

  • Ganesh Avhad · Swasthiye Clinic and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2021-02-27
Completion
2021-03-30

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 NCT04228640 on ClinicalTrials.gov