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CTRI Number  CTRI/2024/11/076167 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study on the Effects of Ashwagandha Moisturizing Cream for Reducing Signs of Aging in Healthy Volunteers 
Scientific Title of Study   An open-label single-arm interventional clinical trial to evaluate the anti-aging efficacy and safety of topical application of Aswagandha moisturizing cream among healthy volunteers 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Hareendran Nair 
Designation  Managing Director and Founder 
Affiliation  Pankajakasthuri Herbal Research Foundation 
Address  Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada

Thiruvananthapuram
KERALA
695572
India 
Phone    
Fax    
Email  hareendrannair@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kasthuri Nair A 
Designation  Director 
Affiliation  Pankajakasthuri Ayurveda Medical college and PG centre 
Address  Pankajakasthuri Ayurveda Medical college and PG centre Killy

Thiruvananthapuram
KERALA
695572
India 
Phone  8113851665  
Fax    
Email  dr.kasthurinair@pkhil.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kaveri Nair A 
Designation  Director 
Affiliation  Pankajakasthuri Ayurveda Medical college and PG centre 
Address  Pankajakasthuri Ayurveda Medical college and PG centre Killy

Thiruvananthapuram
KERALA
695572
India 
Phone  7994461126  
Fax    
Email  dr.kaverinair@gmail.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Herbals India Pvt. Ltd, Poovachal, Trivandrum, Kerala-695575 
 
Primary Sponsor  
Name  Pankajakasthuri Herbals India Pvt Ltd 
Address  Poovachal Trivandrum Kerala Pin: 695575 
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 Kasthuri Nair A  Pankajakasthuri Ayurveda Medical college and PG centre  Room No 1 Department of Kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Thiruvananthapuram
Thiruvananthapuram
KERALA 
8113851665

dr.kasthurinair@pkhil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hair loss 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Aswagandha moisturizing cream , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 16 Weeks, Reference: NA, Route: -, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Subjects willing to provide signed informed consent prior to the study.
2. Healthy male or female participants aged between 25 and 55 years.
3. Subjects with visible signs of mild to moderate skin aging (e.g., fine lines, wrinkles, dryness).
4. Subjects who committed not to use any other cosmetics during the entire duration of the study.
5. Participants willing to comply with the study protocol and follow-up requirements.
6. Fitzpatrick skin types I–IV.
 
 
ExclusionCriteria 
Details  1. Subjects with a history of significant dermatological conditions (e.g., eczema, psoriasis) or skin diseases that may interfere with the assessment.
2. History of systemic or cutaneous malignancy or with nevi or cutaneous lesions currently.
3. Patients with known hypersensitivity to ingredients of the trial drug.
4. Patients with history of facial surgery, cosmetic procedures.
5. Participants in any another clinical trial within 30 days prior to the study.
6. Participants in use of any other antiaging skincare treatments within 4 weeks prior to enrollment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To evaluate the efficacy of the Ashwagandha moisturizing cream in reducing the appearance of fine lines and wrinkles.  Anti-aging effect will be assessed on Visit 1(Week 0), Visit 2(Week 4), Visit 3(Week 8), Visit 4(Week 12) and on the day of follow up Visit (Week 16)” 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate the tolerability and safety profile of the Ashwagandha cream during the study period  Anti-aging effect will be assessed on Visit 1(Week 0), Visit 2(Week 4), Visit 3(Week 8), Visit 4(Week 12) and on the day of follow up Visit (Week 16)” 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   12/11/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
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  

This open-label, single-arm interventional clinical trial aims to evaluate the anti-aging efficacy and safety of a topical Ashwagandha moisturizing cream in reducing the appearance of fine lines and wrinkles among healthy volunteers. Thirty participants will apply the Ashwagandha cream daily over a 16-week period, with assessments conducted at baseline (Week 0), and at Weeks 4, 8, 12, and 16. The primary objective of the study is to assess the cream’s efficacy in reducing wrinkle appearance and fine lines, with secondary objectives including evaluation of tolerability, safety, and overall improvement in skin health as reported by participants.

Clinical wrinkle assessment will be conducted using Standard Wrinkle Scales, focusing on specific facial areas: the Crow’s Feet Wrinkle Scale (CFWS) for the lateral eye area, Forehead Wrinkle Severity Scale (FWSS) for forehead lines, Nasolabial Fold Wrinkle Scale (NLFS) for nasolabial wrinkles, and Global Fine Line Scale (GFLS) for general fine lines. High-resolution digital imaging will be used to objectively record and measure wrinkle depth and fine line counts. Participants will also complete a Self-Assessment Questionnaire evaluating various skin parameters, including hydration, moisture retention, wrinkle reduction, elasticity, firmness, texture, radiance, and overall satisfaction. A Global Tolerability Assessment will be conducted at each visit to monitor safety and participant comfort.

This study is designed to provide insights into the efficacy and tolerability of Ashwagandha moisturizing cream as a topical anti-aging solution, with clinical and subjective measures used to assess its potential in enhancing skin health and appearance.

 
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