| CTRI Number |
CTRI/2025/08/092653 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial in skin health |
|
Scientific Title of Study
|
A Prospective, Open-label, single arm study to evaluate the safety and efficacy of oral consumption of Turmeric Ghee (Ghritham) in improving skin health. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KAL/SH/Turmeric Ghee Version 1.0 dated 02 .01. 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMadan Mohan N T |
| Designation |
Principal investigator |
| Affiliation |
Sri Venkateshwara Hospital |
| Address |
Ground floor Room No 2 Site No 1 SKY Heights, 2, Sarjapura- Attibele Road Bangalore Karnataka
Bangalore
KARNATAKA
562107
India |
| Phone |
9845074316 |
| Fax |
|
| Email |
drmadan1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayashree M |
| Designation |
Chief Scientific Officer |
| Affiliation |
Kerala Ayurveda Ltd |
| Address |
Ground Floor, BKN Ambaram Estate, No. 648/1, Old Madras Road, Binnamangala, 1st Stage, Indiranagar, Bengaluru – India
Bangalore
KARNATAKA
560038
India |
| Phone |
9880677814 |
| Fax |
|
| Email |
Jayashree@keralaayurveda.us |
|
Details of Contact Person
Public Query
|
| Name |
DrSukrutha S |
| Designation |
Lead-Clinical & Scientific Affairs |
| Affiliation |
Kerala Ayurveda Ltd |
| Address |
Ground Floor, BKN Ambaram Estate, No. 648/1, Old Madras Road, Binnamangala, 1st Stage, Indiranagar, Bengaluru – India
Bangalore
KARNATAKA
560038
India |
| Phone |
7338279666 |
| Fax |
|
| Email |
drsukrutha@keralaayurveda.biz |
|
|
Source of Monetary or Material Support
|
| Kerala Ayurveda Ltd Ground Floor, BKN Ambaram Estate, No. 648/1, Old Madras Road, Binnamangala, 1st Stage, Indiranagar, Bengaluru – 560038, India |
|
|
Primary Sponsor
|
| Name |
Kerala Ayurveda Ltd |
| Address |
Ground Floor, BKN Ambaram Estate, No. 648/1, Old Madras Road, Binnamangala, 1st Stage, Indiranagar, Bengaluru – 560038, India |
| Type of Sponsor |
Other [Ayurveda & Wellness ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMadan Mohan N T |
Sri Venkateshwara Hospital |
Ground floor Room No 2
Site No 1 SKY Heights, 2, Sarjapura- Attibele Road Bangalore Karnataka 562107
Bangalore
KARNATAKA |
9845074316
drmadan1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin Health |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Turmeric Ghee, Reference: NA, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: 1 teaspoon with warm water early in the morning on empty stomach), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Indian male/female volunteer aged between 25-50 years (both inclusive)
from different cities.
1. Subjects willing to give Informed Consent Form.
2. Subjects willing to complete the study assessments/questionnaires.
3. Fitzpatrick Skin Type I–V.
4. Minimal to moderate Allergen Skin Roughness Scale.
5. Subjects diagnosed with mild to moderate acne vulgaris based on the
Global Acne Grading System (GAGS) score.
6. Stable vitals and no major systemic illness affecting metabolism or skin
health.
7. Controlled Hypertension and RBS.
8. Willing to avoid usage of his/her own face serum and cream for at least
one week before commencement and during this study.
9. Subjects having acne prone skin |
|
| ExclusionCriteria |
| Details |
1. Subjects with preexisting severe systemic disease necessitating longterm medication
2. Subjects with mild to severe anaphylaxis reactions to turmeric, dairy or related substances
3. Evidence of significant uncontrolled comorbid disease like
4. Type 1 or Type 2 Diabetes Mellitus or uncontrolled blood sugar levels RBS greater than 140 mg/dL at baseline
5. History of dyslipidemia or metabolic syndrome
6. Diagnosed PCOS polycystic ovarian syndrome, thyroid disorders, or other hormonal imbalances
7. GAGS score greater than 30 severe acne with deep nodulocystic lesions or acne conglobata
8. Presence of active dermatitis, eczema, psoriasis, or rosacea
9. Hyperpigmentation disorders like melasma, vitiligo, etc
10. Pregnancy or breast feeding.
11. Participants using oral or topical turmeric supplementation within 4 to 6 weeks
12. Patients with recent skin treatment like use of systemic retinoids, use of topical retinoids, steroids, or antibiotics and undergoing chemical peels, laser therapy, or microneedling for acne within the past 6 months
13. History of cancer including solid tumors, hematologic malignancies and carcinoma in situ
14. Any neurological congenital or acquired, vascular or systemic disorder which could affect any of the efficacy assessments
15. Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage Improvement in skin brightening and skin
hydration (Twak Prasannata) using instrument
corneometer and Allergan Skin Roughness Scale from
baseline (Visit 1, Day 0) to study completion (Visit 4,
Day 60).
2. Percentage reduction of Trans Epidermal water loss
using Tewameter instrument.
3. Percentage Reduction in Mukha Dushti Lakshana
(facial skin issues) using Global Acne Grading System
(GAGS) score from baseline to study completion.
4. Effectiveness in managing signs of aging
(Vayahsthapana) using Wrinkle Severity Rating Scale
(WSRS) from baseline to day 60. |
Day 0 day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage improvement in Immunity (Ojas) –
Evaluated using the Immune Status Questionnaire
(ISQ) scale.
2. No significant deviations in hematology (CBC),
biochemistry (LFT, RFT, Lipid Profile), and RBS
levels at baseline and Visit 4.
3. Monitoring of adverse events (AEs) at each follow-up
visit (Visit 2, 3, and 4).
|
Day 0 day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Formulation Turmeric Ghee combines the time-tested therapeutic potential of Haridra Curcuma longa Linn with the nourishing and tissue-penetrating qualities of Go-Ghrita cows ghee. This combination is specifically indicated for skin-related disorders, age-associated degeneration, and Rasa Rakta Dushti vitiation of bodily fluids and blood. In Ayurveda, skin health is not just superficial but reflects the equilibrium of Doshas, nourishment of dhatus especially Rasa, Rakta, and Meda, and efficient detoxification. Disturbances in these lead to conditions such as Twak Sosha dryness, Vaivarnya discoloration, Mukha Dooshika acne, and Jara premature aging. Turmeric Ghee addresses these root imbalances through its multipronged therapeutic approach.
Our formulation Turmeric Ghee combines the time-tested therapeutic potential of Haridra Curcuma longa Linn with the nourishing and tissue-penetrating qualities of Go-Ghrita cows ghee. This combination is specifically indicated for skin-related disorders, age-associated degeneration, and Rasa Rakta Dushti vitiation of bodily fluids and blood. In Ayurveda, skin health is not just superficial but reflects the equilibrium of Doshas, nourishment of dhatus especially Rasa, Rakta, and Meda, and efficient detoxification. Disturbances in these lead to conditions such as Twak Sosha dryness, Vaivarnya discoloration, Mukha Dooshika acne, and Jara premature aging. Turmeric Ghee addresses these root imbalances through its multipronged therapeutic approach |