CTRI

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CTRI Number

CTRI/2022/09/045429 [Registered on: 12/09/2022] Trial Registered Prospectively

Last Modified On:

29/05/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

Clinical study on Vetiver Concentrate for skin soothing activity

Scientific Title of Study

Evaluation of Efficacy and Safety of Namaskar Ayurved Restore and Refresh Vetiver Concentrate in Healthy participants for its skin soothing and hydration activities- An open label, non-comparative, interventional, prospective, clinical study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
VETICONCEN/NAMSKARAYU/2022/1, Version 1.0, 01st July 2022	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Pawar Sumol Anand
Designation	Assistant Professor
Affiliation	Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur
Address	OPD No. 10, Ground floor, Department of Panchakarma, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur Latur MAHARASHTRA 413512 India
Phone	8793727304
Fax
Email	drsumolapawar@gmail.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 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 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

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Pawar Sumol Anan	Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur	OPD No. 10, Ground floor, Department of Panchakarma, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur Latur MAHARASHTRA	8793727304 drsumolapawar@gmail.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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Skin soothing and hydration activities

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Namaskar Ayurved Restore and Refresh Vetiver Concentrate , Reference: NA, Route: Topical, Dosage Form: Arka, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply Namaskar Ayurved Restore and Refresh Vetiver Concentrate on face twice in a day for a period of 7 days.
2	Comparator Arm (Non Ayurveda)		-	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Healthy Male and female subjects 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 skin hydrating and soothing products (topicals), 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 Namaskar Ayurved Restore and Refresh Vetiver Concentrate
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
Changes in facial cutaneous moisturization	Day 0, 24 hrs. post skin patch test application, 48 hrs. post skin patch test application, Day 3, Day 7

Secondary Outcome

Outcome

TimePoints

1. Changes in overall skin (facial) texture/roughness (Tactile)
2. Changes in overall skin (facial) texture/roughness (Visual)
3. Changes in overall facial skin luminosity/radiance
4. Assessment of 24 hr skin patch test
5. Changes in freshness of the facial skin
6. Changes in facial hyperpigmentation/ dark spot
7. Changes in facial scar
8. Changes in blemishes on facial skin
9. Assessment of mood
10. Global assessment for overall change
11. Assessment of post treatment tolerability of study drug
12. Assessment of adverse events

Screening / Baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 3), visit 4 (Day 7)

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

12/09/2022

Date of Study Completion (India)

12/10/2022

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

NOT YET DONE

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 Namaskar Ayurved Restore and Refresh Vetiver Concentrate in healthy participants for its skin soothing and hydration activities. Subjects will be asked to apply Namaskar Ayurved Restore and Refresh Vetiver Concentrate on face twice in a day for a period of 7 days. The primary objective of the study will be to assess change in facial cutaneous moisturization. Secondary objectives of the study will be to assess changes in overall skin (facial) texture/roughness (Tactile), & (Visual), overall facial skin luminosity/radiance, assessment of 24 hr skin patch test, changes in freshness of the facial skin, facial hyperpigmentation/ dark spot, facial scar, blemishes on facial skin, assessment of mood, global assessment for overall change, post treatment tolerability of study drug and adverse events on screening / baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 3), visit 4 (Day 7)

Results and Conclusion:

Namaskar Ayurved Restore and Refresh Vetiver Concentrate was significantly effective in improving facial cutaneous moisturization, skin (facial) texture /roughness (Tactile and visual), facial skin luminosity, freshness of the facial skin, reduction of facial hyperpigmentation/dark spots, facial scars, blemishes on facial skin, and improvement of overall mood. Namaskar Ayurved Restore and Refresh Vetiver Concentrate was found to be safe for regular use.