| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair loss |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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. |