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Clinical trial on skin health

A randomized, double blind, parallel assignment, placebo-controlled, two arm study to evaluate the safety and efficacy of iGlow (poly herbal preparation) on overall skin health among healthy adult volunteers

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036551
Enrollment
90
Registered
2021-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: I Glow Sachet: Dosage form: Sachet Dose:30 ml Duration: twice a day for 90 days. preferable 15 minutes after lunch and dinner daily. Control Intervention1: Placebo Sachet: Dosage for

Sponsors

IndusViva HealthSciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects in generally good health 2. Subjects age group 18 - 55 years 3. Subjects willing to follow the suggested diet plan. 4. Subjects willing to give a written informed consent and come for a regular follow up 5. Subject willing to abide by and comply with the study protocol 6. Subject has not participated in a similar investigation in the past four weeks. 7. Subjects having visible fine lines and wrinkles in periorbital area (Crowââ?¬•s feet), nasolabial areas, forehead , and perioral regions of the face 8. Subjects having mild to moderate naso-labial folds 9. Subjects having apparent mild to moderate crowââ?¬•s feet in unanimated face 10. Subjects who have not under gone any facial anti-ageing procedures (e.g.Botulinum dermal filler injections, laser resurfacing) in the past 3 months. 11. Subject should be willing to abstain from spa treatments/facials during the study period

Exclusion criteria

Exclusion criteria: 1. A known history or present condition of allergic response to any cosmetic products. 2. Subjects having severe photo-aging. 3. Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings. 4. Subjects on oral medications (e.g. steroids, anti-oxidant) or any skin supplement for skin care which will compromise the study. 5. Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy. 6. Subjects not willing to discontinue other topical anti-ageing, anti- wrinkle facial products. 7. Subjects who are pregnant, lactating or nursing. 8. Hypersensitivity to any component of the tested products. 9. History of intense sun exposure. 10. Chronic illness which may influence the cutaneous state. 11. Subject participating in any other cosmetic or therapeutic trial. 12. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness

Design outcomes

Primary

MeasureTime frame
1. Primary Measurement will be the safety and tolerability of iGlow through, a. Measuring vitals b. Laboratory Parameters Hematology, Biochemistry, liver profile, Kidney profile, Lipid Profile, Urine analysis, FBS & ECG at Screening (- 7 day) and end of the Study (90 day). Timepoint: Day 0 Day 45 and Day 90

Secondary

MeasureTime frame
2. Secondary Measurement will be to assess the efficacy of iGlow through, � Dermatologist�s visual assessment.ii. Instrumental measurements- Visioscan (Skin topography), � Cutometer (Elasticity), Corneometer (Skin Hydration) & � Chromameter (Skin lighting). � iii. Subject�s self-assessment. � iv. Biomarker measurement � a. Procollagen � b. Serum Collagen levels � c. Elastin � d. HAS-1 (Hyaluronic Acid Synthase-1) � e. CoQ10 � f. TEWL ((Transepidermal water loss) � g. Skin elasticity Timepoint: Day 0 Day 45 and Day 90

Countries

India

Contacts

Public ContactMrShariq Afsar Thandu

Radiant Research Services Pvt. Ltd

ashok@radiantresearch.in9880999297

Outcome results

None listed

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