| CTRI Number |
CTRI/2020/05/025054 [Registered on: 06/05/2020] Trial Registered Prospectively |
| Last Modified On: |
14/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Local Application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Kantikara Lepa in Mukha Vaivarnya (Sun Tan) |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Kantikara Lepa and Yashtimadhu Choorna Lepa in Mukha Vaivarnya w.s.r to Sun Tan |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ahana Balakrishnan |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
Department of PG Studies in Swasthavritta
OPD No. 7
Sri Sri College Of Ayurvedic Science And Research
21st Km Kanakapura Road
Udayapura Post
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
7795364694 |
| Fax |
|
| Email |
ahanabalakrishnan03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajitha K |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
Department of PG Studies in Swasthavritta
OPD No. 7
Sri Sri College Of Ayurvedic Science And Research
21st Km Kanakapura Road
Udayapura Post
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9448415810 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahana Balakrishnan |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
Department of PG Studies in Swasthavritta
OPD No. 7
Sri Sri College Of Ayurvedic Science And Research
21st Km Kanakapura Road
Udayapura Post
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
7795364694 |
| Fax |
|
| Email |
ahanabalakrishnan03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research
21st Km Kanakpura Road
Udayapura Post
Banglore-560082 |
|
|
Primary Sponsor
|
| Name |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
Department Of PG Studies in Swasthavritta
OPD NO. 7
Sri Sri College Of Ayurvedic Science And Research
21st Km Kanakapura Road
Udayapura Post
Bangalore-560082 |
| Type of Sponsor |
Private medical college |
|
|
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 Ahana Balakrishnan |
Sri Sri College Of Ayurvedic Science And Research |
Department Of PG Studies in Swasthavritta
OPD No.7
Ground Floor
21st Km Kanakapura Road
Udayapura Post
Bangalore 560082
Bangalore
KARNATAKA |
7795364694
ahanabalakrishnan03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L569||Acute skin change due to ultraviolet radiation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kantikara Lepa |
Application of Kantikara Lepa(quantity sufficient) with milk on face for patients diagnosed with Mukha Vaivarnya (Sun Tan) daily once for 7 days
Follow up will be done on 15th and 21st day
Total duration of trial 21 days |
| Comparator Agent |
Yashtimadhu Choorna Lepa |
Application of Yashtimadhu Choorna Lepa (quantity sufficient) with water on face for patients diagnosed with Mukha Vaivarnya (Sun Tan) daily once for 7 days
Follow up will be done on 15th and 21st day
Total duration of trial 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed with sun tan on face will be included.
2.Subjects of age group between 18 to 35 years will be included irrespective of their gender, religion and socio-economic status.
3.Subjects who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Vaivarnya due to any hormonal and Genetic causes.
2.Photosensitivity of skin due to systemic diseases, side effect of any cosmetic products.
3.Subjects taking photosensitizing drugs like NSAIDS, anti-histamines, oral contraceptives, sulphonamides etc
4.Chloasma / Melasma, post-inflammatory hyperpigmentation will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kantikara Lepa is effective in Mukha Vaivarnya(Sun Tan) |
% improvement will be assessed using Fairness Meter Scale and Statistical analysis will be done
Assessment will be done on 0,5th, 8th day and follow up will be done on 15th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kantikara Lepa and Yashtimadhu Choorna Lepa will be equally effective in Mukha Vaivarnya (Sun Tan) |
% improvement will be assessed using Fairness Meter Scale and Statistical analysis will be done
Assessment will be done on 0,5th, 8th day and follow up will be done on 15th and 21st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/05/2020 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Skin is the largest organ in the body and the first medium of protection. Hyperpigmentation is a condition where there is increased pigmentation of the skin beyond its normal color causing uneven skin tone. Exposure to sun is the number one cause of hyperpigmentation and it is the one that triggers the production of melanin in the first place. Melanin acts as skin’s natural sunscreen by protecting from harmful sun rays, which is why people tan in the sun. Sun tan begins within 5 minutes or even within 24-72 hours after exposure to sun and lasts for few days or weeks.
Varna is the natural color or complexion of the body which is from the birth and is influenced by various factors even after birth. Prakrutha Varna is one among the factors which indicates that the body is in a state of equilibrium and in turn any change can be considered as a Vikriti (imbalance). Twak Vaivarnya (skin discolouration) is the change in natural color or complexion of the skin due to various Nija and Agantuja (internal and external) factors. Vata (wind) and Atapa (sun) are considered as the causes for Vaivarnya. People are more conscious about beauty and skin care, which is the reason why people approaching skin and cosmetic centers have increased drastically in the past years. Any condition related to skin affects emotional and mental well-being of a person in turn affecting the self-confidence causing social stigma and reducing his productivity to the society.Many of the skin lightening agents available will either inhibit or reduce melanin secretion which makes skin more sensitive to sunlight and skin loses its natural healing property. So there is a requirement for cost effective and easy preparations for hyperpigmentation.There are various formulations in Samhita to treat Twak Vikara and also to improve the attributes of skin. This is an effort made to evaluate and analyse the efficacy of Kantikara lepa and Yashtimadhu choorna lepa in Mukha Vaivarnya w.s.r to Sun tan. |