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Evaluation of a Nutraceutical Supplement for Improving Skin, Vitality, Cognition, and Sleep in Adults

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Nutraceutical Supplement in Promoting Healthy Aging - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098299
Enrollment
60
Registered
2025-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

None listed

Interventions

Intervention1: NGGSAG(1199 mg) Tablet: For Duration 90 days: 1. Curcuminoids soft extract (contain 95 % Curcuminoids) -180 mg 2. Astragalus root extract -250 mg 3. Brassica campestr

Sponsors

Hirehal Greenspace Herbs Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male and female participants, aged between 30-65 years (preferably more participants aged 30 49 years). 2. Generally healthy as determined by medical history and physical examination or exhibiting mild age-related changes (e.g., dry skin, reduced skin elasticity, fine lines, fatigue, reduced cognitive functioning like difficulty concentrating or poor sleep quality). 3. Healthy volunteers with no significant medical conditions. 4. Individuals with Fitzpatrick skin phototypes III to V, representing the typical skin types in the Indian population. 5. Willingness to refrain from consuming any other cognitive, protein or anti-aging supplements during the study period (including energy drinks, gums, or protein supplements containing caffeine or other stimulants). 6. Stable use of routine medications or supplements for at least 4 weeks prior to baseline, with no anticipated change during the 12-week study period. 7. Willingness to avoid exposure to both natural and artificial UV light during the study. 8. Ability and willingness to comply with all study procedures, including scheduled visits, and adherence to the investigational product regimen. 9. Capability and willingness to provide written informed consent prior to participation.

Exclusion criteria

Exclusion criteria: 1. Known allergies or hypersensitivity to any ingredient of the study products. 2. History or current diagnosis of neurocognitive disorder (e.g., dementia, Alzheimer s disease, mild cognitive impairment with clinical diagnosis). 3. Current Severe Depressive Episode, bipolar disorder, schizophrenia, or other severe psychiatric illnesses that could affect cognition. 4. Undergoing any treatment known to interfere with the study product or outcomes. 5. Individuals with diagnosed autoimmune or chronic inflammatory conditions. 6. Presence of acute, chronic, or progressive illness that may interfere with study data or pose risk to the participant. 7. Severe uncontrolled cardiovascular, hepatic, renal, or metabolic disorders that could interfere with study participation. 8. Current use of hormone replacement therapy or immunosuppressive agents. 9. Active smokers or individuals with high alcohol consumption (more than 2 standard drinks per week) or a history of binge drinking. 10. Active dermatological conditions or a history of significant dermatological disorders that may interfere with study assessments. 11. Participants participated in another clinical trial within 6 months. 12. Inability to read, write, or comprehend language sufficient to complete study questionnaires and cognitive tests. 13. Any condition that, in the opinion of the investigator, may interfere with study participation, study assessments, or pose undue risk to the participant. 14. Pregnant or lactating women, or women planning pregnancy during the study period.

Design outcomes

Primary

MeasureTime frame
a) Change in Skin health (elasticity, hydration, barrier integrity) from baseline to end of the study measured using Derma Lab Probes. b) Assessment of cognitive performance measured using NIMHANS Neuropsychological Battery from Baseline to End of Study. c) Assessment of vitality and well-being using SF-36 Questionnaire at Baseline and End of Study. d) Assessment of sleep quality using Pittsburgh Sleep Quality Index (PSQI) at Baseline and End of Study.Timepoint: Baseline (Day 0), Week 6 and Week 12 (EOS)

Secondary

MeasureTime frame
Change in vital signs and Heart Rate Variability (HRV) (Baseline, Week 6, End of Study). b) Assessment of adverse events, complete blood count (CBC), liver function test (LFT) and kidney function test (RFT) (Baseline and End of Study).Timepoint: Baseline (Day 0), Week 6 and Week 12(EOS)

Countries

India

Contacts

Public ContactMeena Dalal

TrialGuna Private Limited

prithvi.navada@gmail.com8727081100

Outcome results

None listed

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