| CTRI Number |
CTRI/2023/06/054483 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Ashwagandha topical lotion on the Skin Health in Healthy Adults |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy & Safety of Ashwagandha Lotion in Photo-Aged Healthy Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ixoreal-Hair-CT-05-23, Version 1, dt. 14 Feb. 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shylaja Someshwar |
| Designation |
Principle investigator |
| Affiliation |
MGM Medical College |
| Address |
MGM Medical College, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Raigarh
MAHARASHTRA
400706
India |
| Phone |
09820500964 |
| Fax |
|
| Email |
mgmderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shylaja Someshwar |
| Designation |
Principle investigator |
| Affiliation |
MGM Medical College |
| Address |
MGM Medical College, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Raigarh
MAHARASHTRA
400706
India |
| Phone |
09820500964 |
| Fax |
|
| Email |
mgmderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shylaja Someshwar |
| Designation |
Principle investigator |
| Affiliation |
MGM Medical College |
| Address |
MGM Medical College, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Raigarh
MAHARASHTRA
400706
India |
| Phone |
09820500964 |
| Fax |
|
| Email |
mgmderma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited |
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (91) 40-23204385 / 86 / 87 India |
| 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 |
| Shylaja Someshwar |
MGM Medical College & Hospital |
Dermatology department, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Raigarh
MAHARASHTRA |
09820500964
mgmderma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and Female 18 to 60 years of age
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha topical lotion
formulation |
Ashwagandha topical lotion to
be applied two times daily for 90 days. |
| Comparator Agent |
Identical Placebo lotion
formulation |
Identical Placebo lotion to be
applied two times daily for 90
days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult men and women participants? 18 years and ?60 years of age.
2. Participants who agree not to use any
medication (prescription and over the counter), including vitamins and minerals, during or before the course of this study.
3. Participants willing to undergo preparation for Facial Skin Assessment
4. Willingness to follow the protocol requirements as evidenced by written informed consent.
5. Good general and mental health with, in the opinion of the investigator or medically qualified designee not clinically significant and relevant abnormalities in medical history or upon physical examination
6. Participants or LAR can and are willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
7. Participants with Fitzpatrick photo-type III-VI
skin
8. Participants who agree to take the investigational product (i.e., Till Day 90 ± 4). |
|
| ExclusionCriteria |
| Details |
1. Participants having any clinically significant medical history,
medical finding including rosacea, eczema, psoriasis, and atopic
dermatitis or an on-going medical or psychiatric condition exists
which in the opinion of the Investigator could jeopardize the safety of
the subject, impact validity of the study results or interfere with the
completion of study according to the protocol.
2. Participants having a history of hypersensitivity reactions (i.e.,
allergic or oversensitivity to usual doses).
3. Participants who have participated in a clinical study during the
preceding 180 days.
4. Participants with a medical history of using a medicated acne
treatment within the last 6 months.
5. Participants with active skin disease in the test area.
6. Participants with a medical history of dysplastic nevi or melanoma
on the face.
7. Participants with moles, cysts, tattoos, scars, irritated skin, hairs,
etc. at the test area that could influence the investigation
8. Participants on systemic therapy with immuno-suppressive drugs
(e.g., corticosteroids) and/or antihistamines within 7 days prior to the
start of the study and/or throughout the entire course of the study.
9. Participants on systemic use of anti-microbials within the last
month.
10. Participants with a medical history ofabnormal response to
sunlight.
11. Participants with a history of mental illness.
12. Participants who are medically diagnosed acne vulgaris, acne
conglobate, fulminans, secondary acne (drug induced acne) or any
acne requiring systemic or topical treatment.
13. Participants who had an aesthetic, cosmetic or dermatological
treatment in the treatment area (face) within the last month.
14. Participants who had intense sun exposure, UV-treatments or
tanning salon visit within the last 2 weeks.
15. Participants with a known or suspected intolerance, allergy, or
hypersensitivity to study materials (or closely related compounds) or
any of their stated ingredients.
16. Participants with a history of allergies to cosmetic products or
medicated acne treatments.
17. Participants with any other condition which the principal
investigator thinks may jeopardize the safety of subjects— patients
with uncontrolled, unstable comorbidities.
18. Participants working outdoors. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in total score of Global Physician Assessment
|
Baseline, 12 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Trans epidermal water loss (TEWL) measurement
|
Baseline, 12 Weeks |
Self-Assessment Questionnaire
|
Baseline, 12 Weeks |
| Short Form Survey (SF-12) |
Baseline, 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/06/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Efficacy assessments mentioned above will be done appropriately during the study. All Subjects will be followed-up during the study period (Screening /Baseline, Day-45 (telephonic), and Day 90 ± 4) till complete the course of treatment. |