| CTRI Number |
CTRI/2022/07/044468 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Namskar Ayurved’s Repair and Restore Moisturizing Body Oil |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Namskar Ayurved’s Repair and Restore Moisturizing Body Oil in Healthy participants - An open label, non-comparative, interventional, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MOISOIL/NAMSKARAYU/2022/1, Version 1.0, 11th June 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malwade Ganesh P |
| Designation |
Assistant Professor |
| Affiliation |
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
| Address |
Department of Shalyatantra, OPD No 2, Ground Floor, Late. Babruwan Vitthalrao Kale Ayurved medical college and Hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9890914153 |
| Fax |
|
| Email |
ganesh.malwade@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Namaskar Ayurved Private Limited,
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013 |
|
|
Primary Sponsor
|
| Name |
Namaskar Ayurved Private Limited |
| Address |
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013 |
| 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 Malwade Ganesh P |
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital |
Department of Shalyatantra, OPD No 2, Ground Floor, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Behind Bus Stand, Gandhi Maidan, Latur – 413512
Latur
MAHARASHTRA |
9890914153
ganesh.malwade@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mild to moderate skin dryness |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Namskar Ayurved’s Repair and Restore Moisturizing Body Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Subjects will be advised to apply Namskar Ayurved’s Repair and Restore Moisturizing Body Oil all over the body after taking bath every day for a period of 30 days | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed mild to moderate skin dryness assessed using clinical grading score
2. Willing to comply with all requirements of the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
2. Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
3. Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
4. Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs. Moisturizing cream, lotion or oil within 21 days before entering the trial
5. Subjects on any other investigational products within 1 month prior to randomization
6. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure
7. Pregnant and lactating women
8. Known hypersensitivity to any of the ingredients of Namskar Ayurved’s Repair and Restore Moisturizing Body Oil
9. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in skin cutaneous moisturization/skin dryness |
Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in overall skin texture/roughness (Tactile) and (Visual)
2. Changes in overall skin desquamation/flakiness and luminosity/radiance
3. Change in facial skin lightening and blemishes on skin
4. Assessment of 24 hr skin patch test
5. Difference in number of comedones (blackheads and whiteheads) on the face and body
6. Assessment of ability of study drug to absorb into the skin, oily/greasy appearance and feeling of oil on skin
7. Global assessment for overall change by participants and by physician
8. Assessment of post treatment tolerability of study drug by participants and physician.
9. Assessment of adverse events
|
Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
07/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Namskar Ayurved’s Repair and Restore Moisturizing Body Oil in Healthy participants. Subjects will be asked to apply Namskar Ayurved’s Repair and Restore Moisturizing Body Oil all over the body after taking bath every day for a period of 30 days. The primary objective of the study will be to assess change in skin cutaneous moisturization/skin dryness. The secondary objectives of the study will be to assess changes in overall skin texture/roughness (Tactile) and (Visual), changes in overall skin desquamation/flakiness and luminosity/radiance, change in facial skin lightening and blemishes on skin, assessment of 24 hr skin patch test, difference in number of comedones (blackheads and whiteheads) on the face and body, ability of study drug to absorb into the skin, oily/greasy appearance and feeling of oil on skin, global assessment for overall change by participants and by physician, assessment of post treatment tolerability of study drug by participants and physician and assessment of adverse events on Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30)
Results and Conclusion:
Namskar Ayurved’s Repair and Restore
Moisturizing Body Oil was significantly effective in improving skin cutaneous
moisturization/skin dryness, skin texture/roughness (Tactile and visual), skin desquamation/flakiness, overall
skin luminosity/radiance and reducing skin blemishes and comedones. It was
also effective in improving skin colour and skin glow. It was tolerated well
by all the subjects. Hence, Namskar Ayurved’s Repair and Restore
Moisturizing Body Oil can be used daily as an effective remedy for management of skin
dryness. |