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Clinical Study of Nutraceutical Test Samples in Healthy Adult Subjects

A Randomized, Double-Blind, Three-Arm, Placebo-Controlled, Comparative, Clinical Study to Evaluate the Efficacy of Nutraceutical Test Samples (As coded Test Products A, B and C) on Healthy Adult Subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033557
Enrollment
45
Registered
2021-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

None listed

Interventions

Intervention1: Patanjali Nutrela Daily Active/Patanjali Nutrela Sport Daily Active: one capsule of test product/day in the morning after meal for 30 days Intervention2: Patanjali Nutrela Daily Energy/

Sponsors

Patanjali Ayurved Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 35 to 50 years (inclusive) at the time of consent. 2. Sex: Males and Non-pregnant/Non-lactating Females (preferably equal numbers of males and females). 3. Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit and agree to follow an accepted method of birth control for the duration of the study. 4. Corporate Subjects with complaint of feeling exhausted with routine and impaired due to lack of energy. 5. Subjects with ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed. 6. Subjects willing to follow all study instructions and report to facility for all follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Subjects with acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis). 2. History of substance or alcohol abuse within the last 2 years. 3. Subjects who are using additional suppliments, using medications (e.g. antihypertensive medications, lipid reducers, thyroid medication). 4. Female subjects who are Pregnant or lactating women. 5. Any individual who is involved with conduct of this study. 6. Subjects who have participated in another study with any investigational product within 3 months of randomization. 7. Subject having history of/or currently using medication which in the opinion of the investigator may affect the evaluation of the study product, or place the participant at undue risk. 8. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study evaluation.

Design outcomes

Primary

MeasureTime frame
1.Subjective perception about test products •Lifestyle related questionnaires •Symptoms on energy level •Satiety Level Timepoint: 1.Day 01 to Day 15 and Day 30

Secondary

MeasureTime frame
1. Safety of test products will be determined by adverse event, if any, reported by the Principal Investigator along with self-reported by subjects.Timepoint: 1. Day 01 to Day 15 and Day 30

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

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