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A clinical study to assess the influence of nutraceutical formulations on physical performance and exercise capacity of healthy volunteers

A Randomized, double blind, placebo controlled, parallel group study on safety and efficacy of LF1485, COCZ021 and CUQ1720 on physically active healthy subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038653
Enrollment
140
Registered
2021-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: LF1485: Oral administration of single LF1485 sachet in 240 mL water once a day for 28 days Intervention2: COCZ021: Oral administration of single COCZ021 sachet in 240 mL water once a da

Sponsors

Akay Natural Ingredients Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects with a BMI 20 to 26 kg/m2 2. physically active subjects with minimum 20 min walking/day 3.Shall not be taking any kind of daily medication for the last six months 4.Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study 5.Non Smokers 6.Must be willing and able to give informed consent and comply with the study procedures

Exclusion criteria

Exclusion criteria: 1.Subjects having symptoms of viral infection, including COVID-19 infection 2.Subjects with clinically significant comorbidity 3.Subjects who are on parental insulin, statins or any other lipid lowering drugs 4.Known HIV or Hepatitis B positive or any other immuno-compromised state 5.Subjects allergic to herbal products or any component of the study product 6.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 7.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study

Design outcomes

Primary

MeasureTime frame
Changes in physical performance and exercise capacityTimepoint: Day 0 , Day 14 , Day 21, Day 28

Secondary

MeasureTime frame
Changes in Bio marker levelsTimepoint: Day 0 , Day 14 , Day 21, Day 28;Overall safety assessmentsTimepoint: Day 0 , Day 14 , Day 21, Day 28

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com9845125293

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026