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Multicentre, Double-blind Study Versus Placebo on Impact and Safety of Extramel® 140 IU on Perceived Stress, Physical and Intellectual Fatigue, Pain Perception if Present, and the Impact on the Quality of Life

NCT01767922 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2013-01-18

No results posted yet for this study

Summary

Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress, physical and intellectual fatigue, pain perception, if present, and the impact on the quality of life of 70 subjects included with 60 that can be evaluated.

Conditions

Interventions

DIETARY_SUPPLEMENT

Extramel 10 mg - 140 UI SOD

Subjects took one capsule of Extramel® 140 IU, or its corresponding placebo, daily over 12 weeks. Each volunteer was seen for the 3 visits: * visit V1, so-called inclusion visit (D0), * visit V2 at 28 days, tolerance of +/- 3 days, (D28) and * visit V3 at 84 days, tolerance of +/- 3 days, (D84).

DIETARY_SUPPLEMENT

Placebo - Excipient only

Sponsors & Collaborators

  • Seppic

    collaborator INDUSTRY

  • Bionov

    lead INDUSTRY

Principal Investigators

  • Thierry CANTIN, MD

  • Patrick LEPRINCE, MD

  • Hubert TAUPE, PharmD · ISOCLIN

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-05-31
Completion
2009-09-30

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Entities

Diseases

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 NCT01767922 on ClinicalTrials.gov