| CTRI Number |
CTRI/2024/10/075477 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Dermatology-Topical Cream] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Test the Safety and Effects of Ethniq Skin Revive in Patients with Different Skin Problems. |
|
Scientific Title of Study
|
A Phase 3, Open-Label, Randomised, Multi-Arm, Single-Centered Clinical Study To Evaluate The Safety, Tolerability, And Efficacy Of Ethniq Skin Revive. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2412 Version No. 1.0 Dated 12/Jun/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Kumar S |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Uday’s Advance Skin and Hair clinic |
| Address |
Dr. Uday’s Advance Skin and Hair clinic #2637/6, First Floor, Begur Rd Near Canara Bank, Begur.
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
drudaykumar.derma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi L M |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
9739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Ethniq Ayush Exports LLP
D-179,Phase-8b, Sector 74, Chandigarh Sector 55, Rupnagar, S.A.S Nagar (Mohali), Punjab, India, 160055. |
|
|
Primary Sponsor
|
| Name |
Ethniq Ayush Exports LLP |
| Address |
D-179,Phase-8b, Sector 74, Chandigarh Sector 55, Rupnagar, S.A.S Nagar (Mohali), Punjab, India, 160055. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr Uday Kumar S |
Currex Hospital Bangalore |
Currex Hospital,
No.55,56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli, KS Halli,
Bengaluru, Karnataka 560049.
Bangalore
KARNATAKA |
6364898825
drudaykumar.derma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B49||Unspecified mycosis. Ayurveda Condition: DADRU-KUSHTHAH, (2) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH, (3) ICD-10 Condition:L639||Alopecia areata, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, (4) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: KSHUDRAKUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ethniq skin revive, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Arm 4: Dry Eczema This group will include 50 patients diagnosed with dry eczema. Participants will apply Ethniq Skin Revive twice daily to the affected areas of their skin for a period of 90 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ethniq skin revive, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Arm 2: Superficial Fungal Infections In this arm, 50 patients with superficial fungal infections. Each participant will apply Ethniq Skin Revive twice daily to the affected areas for 90 days. | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ethniq skin revive, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Arm 3: Alopecia Areata This group will include 50 participants with alopecia areata. The participants will apply Ethniq Skin Revive twice daily to the affected scalp areas for 90 days. | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ethniq skin revive, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Arm 1: Psoriasis This group will include 50 patients diagnosed with psoriasis. Participants will apply Ethniq Skin Revive twice daily to the affected areas of their skin for a period of 90 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female patients aged 18 and above with moderate to severe psoriasis (at least 25 percent Body Surface Area involvement excluding scalp, face, groin, axillae, and intertriginous areas).
2.Psoriasis Global Assessment (PGA) score of at least 3.
3.Patients with superficial fungal infection.
4.Participants with alopecia areata with at least 30% scalp hair loss (SALT score ≥ 30).
5.Patients presenting symptoms of dry eczema such as swelling, pricking sensation, intense itching, swelling of the body with itching, fatigue, giddiness, emaciation, blabbering, fleshy odor.
6.Willingness to attend regular follow up visits.
7.Written informed consent.
8.Subjects who have not participated in a similar study in the last 4 weeks.
|
|
| ExclusionCriteria |
| Details |
1.History of adverse reactions to Cosyntropin or similar test reagents.
2.Psoriasis involving only the scalp, face, groin, axillae, and/or other intertriginous areas.
3.Current diagnosis of types of psoriasis other than stable plaque psoriasis.
4.History of psoriasis unresponsive to topical corticosteroid therapy.
5.Known history of androgenic alopecia or female pattern hair loss prior to alopecia areata.
6.Use of topical or systemic treatments that could interfere with psoriasis status or HPA axis function.
7.Other dermatological conditions that may interfere with the assessment of psoriasis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Psoriasis
1.Change in PASI score at day 90 compared to baseline.
2.Change in PGA score at day 30, 60, 90 compared to baseline.
|
Day 1, Day 30, Day 60 and Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Fungal Infections:Clinical cure rate at day 90 and mycological cure rate at day 30, 60, 90.
2.Alopecia Areata:Change in SALT score at day 90 compared to baseline and hair regrowth as assessed by photographic and investigator assessments at day 30, 60, 90.
3.Dry Eczema:Change in severity of symptoms score from baseline to day 90 and improvement in skin hydration and barrier function at day 30, 60, 90.
|
Day 1, Day 30, Day 60 and Day 90
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| Date of Study Completion (India) |
01/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Efficacy Findings: Psoriasis Arm: * The mean PASI score decreased significantly from a baseline value of 32.88 (±7.76) to 4.204 (±1.2) at Day 90, representing a mean reduction of 28.676 points (p < 0.001). * The Physician’s Global Assessment (PGA) improved from an average baseline score of approximately 3.78–4 (indicative of moderate to severe disease) to around 0.28–0 at Day 90 (indicative of minimal to cleared disease). * These improvements are consistent with a clinically meaningful reduction in disease severity.
Fungal Infections Arm: * Considering that subjects achieving either complete absence (coded as 1) or mild (coded as 2) symptoms are classified as “cured,” the clinical cure rate improved from 8% at baseline to 98% at Day 90 (p < 0.05), indicating a marked improvement in the resolution of fungal infection signs and symptoms.
Alopecia Areata Arm: * The mean SALT score decreased significantly from 41.012 (±2.36) at baseline to 12.89 (±1.6) at Day 90 (p < 0.05), demonstrating effective hair regrowth as corroborated by photographic assessments.
Dry Eczema Arm: * Symptom severity scores decreased from a mean of 2.53 (on a 0–3 scale) at baseline to 1.2 at Day 90, while skin hydration scores improved significantly (p < 0.001), indicating both symptomatic relief and improved skin barrier function. Patient-Reported Outcomes: Patient-reported measures showed consistent improvements across all arms. Quality of Life (QoL) responses, as well as assessments of emotional well-being and treatment satisfaction, indicated that a higher percentage of subjects reported improved daily functioning and reduced stress by Day 90. These improvements reinforce the clinical findings and suggest that the benefits of Ethniq Skin Revive extend beyond objective clinical endpoints.
Safety Profile: The safety analysis revealed that Ethniq Skin Revive was well tolerated. No serious adverse events were reported, and the overall incidence of adverse events was minimal. Vital signs remained stable throughout the study, and treatment compliance was 100% across all arms. These safety findings are critical in supporting the favourable risk–benefit profile of the treatment.
Overall Conclusions: The data from this study provide robust evidence that Ethniq Skin Revive offers statistically significant and clinically meaningful improvements in both objective clinical measures and patient- reported outcomes across all four treatment arms. The favourable safety profile further supports its use as an effective treatment option for psoriasis, superficial fungal infections, alopecia areata, and dry eczema. |