| CTRI Number |
CTRI/2018/09/015748 [Registered on: 18/09/2018] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY TO ASSESS THE EFFECTIVENESS OF DAILY MASSAGE WITH SESAME OIL ON SKIN |
|
Scientific Title of Study
|
PRE AND POST SINGLE ARM CLINICAL TRIAL ON THE EFFECT OF NITHYA ABHYANGA( DAILY OIL MASSAGE ) WITH SESAME OIL (TILA TAILAM) ON HUMAN SKIN LAYERS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Sasi |
| Designation |
2nd Year Post Graduate Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Swasthavritta Amrita School of Ayurveda
Amrita Vishwa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala
Amrita School of Ayurveda
Amrita Vishwa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala
Kollam
KERALA
690525
India |
| Phone |
8138856460 |
| Fax |
|
| Email |
mailtodrpooja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anusree Dileep |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Swasthavritta
Amrita School of Ayurveda
Amrita Vishwa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala
Amrita School of Ayurveda
Amrita Vishwa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala
Kollam
KERALA
690525
India |
| Phone |
9446055144 |
| Fax |
|
| Email |
dranusree15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Sasi |
| Designation |
2nd Year Post Graduate Scholar Department of Swasthavritta |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Swasthavritta
Amrita School of Ayurveda
Amrita Vishwa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala
Amrita School of Ayurveda
Amrita Vishwa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala
Kollam
KERALA
690525
India |
| Phone |
8138856460 |
| Fax |
|
| Email |
mailtodrpooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMRITA SCHOOL OF AYURVEDA AMRITA VISHWA VIDHYAPEEDAM VALLIKKAVU
CLAPPANA (P.O)
KOLLAM, KERALA
|
|
|
Primary Sponsor
|
| Name |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda
Amrita Viswa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala |
| 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 |
| Pooja Sasi |
Amrita School of Ayurveda |
Amrita School of Ayurveda
Amrita Viswa Vidhyapeetham
Vallikkavu Clappana(PO)
kollam kerala
Kollam
KERALA |
8138856460
mailtodrpooja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal persons free from signs and symptoms of any illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Full body oil massage using sesame oil. |
20 minutes of full body oil massage has to be done by volunteers for a duration of 30 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers ( undiagnosed for any diseases, not under any medication) between the age group of 35-39.
|
|
| ExclusionCriteria |
| Details |
Persons with skin allergies or other skin infections, persons with digestive complaints, obese persons, and those with Hypercholesterolemia( total cholesterol > 239 and LDL > 190) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the epidermal and Dermal thickness,Structural change in elastin and collagen fibers,moisture content in dermis, change in colour of the skin,elasticity of skin before intervention |
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the epidermal and Dermal thickness,Structural change in elastin and collagen fibers,moisture content in dermis, change in colour of the skin,elasticity of skin after the intervention. |
10 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2018 |
| Date of Study Completion (India) |
02/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In Ayurveda oil massage is an important part in the dinacharya (daily regimen) of a person. Charaka, Susruta and Vagbhata has mentioned about the health benefits of performing oil massage of which the highlighted one is its effect on skin, effect in delaying aging and strengthening the tone of skin. Sesame oil is the best according to acharya charaka, it is especially good for skin and it also improves the strength of a person. 20 Healthy Volunteers between the age group of 35-39 will be selected and their skin condition is assessed with histological parameters like melanin pigments,epidermal thickness,dermal volume, dermal moisture content ,elastin and collagen fibers and dermatological parameters like skin colour,brightness,elasticity, moisture are assessed using DermaLabComboSeries; the assessment will be done on Amrita School of Ayurveda. Then they will be provided with sesame oil obtained from a trustable source. They will be taught about the method of doing abhyanga and will be advised to follow daily massage for about 30 days for about 20 minutes. After 30 days again the assessment of skin will be conducted using DermaLabComboSeries. Pre and post changes will be noted and statistical analysis will be performed to understand the effect of abhyanga on skin. |