FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047537 [Registered on: 22/11/2022] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to Check the Effect and Safety of Ashwagandha Lotion in Aging by sunlight in Healthy Subjects. 
Scientific Title of Study   A Prospective, Double-Blind, Randomized, Parallel, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Lotion in Photo-Aged Healthy Subjects.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IB-SC-CT10-22 Version 01 Dated 23-Aug-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Keerthi N 
Designation  Principle Investigator 
Affiliation  Skintis Clinic Medical and Cosmetic Dermatology and Gynaecology  
Address  Skintis Clinic Medical and Cosmetic Dermatology and Gynaecology 7/56/19 SBR SIRI Building, Unit no 204, Second floor, Dargah Rd, Raidurg, Radhenagar, Gachibowli, Hyderabad, Telangana 500035

Hyderabad
TELANGANA
500035
India 
Phone  9515378114  
Fax    
Email  naarakeerthi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sornaraja Thasma  
Designation  Director of Quality Assurance  
Affiliation  ProRelix Services LLP 
Address  Prorelix Services LLP 102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  8124806366   
Fax    
Email  s.thasma@prorelixresearch.com  
 
Details of Contact Person
Public Query  
Name  Mr Sohal Pendse 
Designation  Director of Business Operations 
Affiliation  ProRelix Services LLP 
Address  Prorelix Services LLP 102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  9890096725   
Fax    
Email  s.pendse@prorelixresearch.com  
 
Source of Monetary or Material Support  
Ixoreal Biomed, Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India.  
 
Primary Sponsor  
Name  Ixoreal Biomed  
Address  Ixoreal Biomed, Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India.  
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 Keerthi N   Skintis Clinic Medical and Cosmetic Dermatology and Gynaecology  7/56/19 SBR SIRI Building, Unit no 204, Second floor, Dargah Rd, Raidurg, Radhenagar, Gachibowli, Hyderabad, Telangana 500035
Hyderabad
TELANGANA 		 9515378114

naarakeerthi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Deccan Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Photo- aged in terms of Skin wrinkles, pores, pigmentation, hydration and brightness of the facial skin  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical Placebo formulation 2 ml   Applying the skin lotion daily once for 60 days 
Intervention  KSM-66 Ashwagandha Skin lotion  KSM-66 Ashwagandha Skin lotion 2ml apply daily once for 60 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 more than equal to 18 years and less than equal to 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 no clinically significant and relevant abnormalities in medical history or upon physical examination.
6.Participants or LAR are able to and 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 investigational product (i.e., Till Day 60 ± 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 of abnormal 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, Ultraviolet (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   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in total score of Global Physician Assessment of Skin Wrinkles, Pores, Hydration/ Moisture, Brightness Tone, and Pigmentation of facial skin excluding scalp.
The signs will be scored using a 6 point grading scale, (0 is equal to None, 1 is equal to Minimal,
2 is equal to Mild, 3 is equal to Moderate, 4 is equal to Moderately Severe, 5 is equal to Severe). 		 Baseline and Day 60 ± 4 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean change in Transepidermal water loss (TEWL) from Visit 1, Screening Visit or Enrolment Visit or Baseline Visit, (Day 1) to Visit 3, End of study (Day 60 ± 4)
2. Mean change in Self - Assessment Questionnaire from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 60 ± 4)
3. Mean change in Self - Assessment Questionnaire (SF-12) scores from Visit 1, Screening Visit or Enrolment Visit or Baseline Visit, (Day 1) to Visit 3, End of study (Day 60 ± 4)
4. Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 08 weeks treatment period 		 Baseline and Day 60 ± 4 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2022 
Date of Study Completion (India) 31/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Fifty-Six healthy male and female of age more than equal to 18 years and less than equal to 60 will be assigned in 1:1 ratio to treatment with the test product, KSM-66 Ashwagandha Skin lotion or Placebo in this double-blind, randomized, placebo-controlled study. All 56 enrolled subjects will be asked to After cleansing, KSM-66 Ashwagandha® 2ml skin lotion should be applied to the face until well absorbed. Subjects will be required to apply daily once for 60 days at home. Subjects will be required to use diaries to document the date, time and dosage of the study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with Change in total score of Global Physician Assessment of Skin Wrinkles, Pores, Hydration/ Moisture, Brightness Tone, and Pigmentation of facial skin excluding scalp will be evaluated and secondarily Mean change in TEWL and mean change in self-assessment questionnaire will be evaluated at baseline visit and at the end of study. 
 
Close