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CTRI Number  CTRI/2024/12/077521 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study the effect of sesame oil for greying of hairs 
Scientific Title of Study   Randomised clinical trial to study the effect of sesame oil shiroabhyanga in the management of palitya 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanchan Ramdas Gawande  
Designation  B.A.M.S PG scholar 
Affiliation  Vidarbha ayurved mahavidyalaya Amravati  
Address  Opd 18 Swasthavritta department Vidarbha ayurved mahavidyalaya Amravati

Amravati
MAHARASHTRA
444606
India 
Phone  9421942494  
Fax    
Email  gawandedrkanchan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay k chopkar  
Designation  Associate professor  
Affiliation  Vidarbha ayurved mahavidyalaya Amravati  
Address  Opd 18 Swasthavritta department Vidarbha ayurved mahavidyalaya Amravati Maharashtra

Amravati
MAHARASHTRA
444606
India 
Phone  9423105104  
Fax    
Email  skchopkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kanchan Ramdas Gawande  
Designation  B.A.M.S pg scholar  
Affiliation  Vidarbha ayurved mahavidyalaya Amravati Maharashtra  
Address  Opd 18 Swasthavritta department Vidarbha ayurved mahavidyalaya Amravati Maharashtra
Vidarbha ayurved mahavidyalaya Amravati Maharashtra
Amravati
MAHARASHTRA
444606
India 
Phone  9421942494  
Fax    
Email  gawandedrkanchan@gmail.com  
 
Source of Monetary or Material Support  
Opd patients of vidarbh ayurved mahavidyalaya Amravati and periphery Maharashtra India 444606 
 
Primary Sponsor  
Name  Kanchan Ramdas Gawande  
Address  Vidarbha ayurved mahavidyalaya Amravati Maharashtra India 444606 
Type of Sponsor  Other [Self] 
 
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 
Drkanchan Ramdas Gawande   vidarbha ayurved mahavidyalaya and Hospital Amravati   Opd no 18 Swasthavritta department Vidarbha ayurved Hospital Amravati 444606 Maharashtra
Amravati
MAHARASHTRA 		 9421942494

gawandedrkanchan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee Vidarbha ayurved mahavidyalaya Amravati   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals with greying of hair 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् (Procedure Reference: Shiroabhyanga , Procedure details: Sesame oil shiroabhyanga before bath 20ml for 15 minutes )
(1) Medicine Name: Sesame oil , Reference: Charak sutrasthan , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 6 Months
2Comparator ArmLifestyle--Dinacarya: As per patient condition , Ritucarya: As per patient condition , Acara Rasayana:No, Other:No, Pathya/Apathya:yes, Pathya:Mung daal, rajgira, coconut water,green leafy vegetables,cow milk, cow ghee,fruits,etc., Apathya:Pickles,salt items, papad, farsan, maida, potato, chips,excess oil, fried food,etc
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. subjects having age between 18 to 45 years irrespective of their sex and socioeconomic status.
2. subjects having signs of palitya.
3. subjects ready to give informed consent. 
 
ExclusionCriteria 
Details  1. Subjects having history of any general systemic illness.
2. ANC women and Lactating mothers.
3. Subjects on any other medications.
4. Subjects having chronic disease and genetic disorder like albinism. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To study the effect of sesame oil shiroabhyanga in the management of palitya.
2. To study the properties of sesame oil.
3. To study the effect of sesame oil for greying of hairs.
 		 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the conceptual aspects of palitya.
2. To study the effect of sesame oil for greying of hairs.
 		 16 months  
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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 2 
Date of First Enrollment (India)   30/12/2024 
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="1"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 05-08-2024 and end date provided 05-02-2026?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - drkanchantayade@gmail.com
Brief Summary   Title- Randomized clinical trail to study the effect of sesame oil shiroabhyanga in the management of palitya.
Aim- To study the effect of sesame oil shiroabhyanga in the management of palitya.

Objective -
 Primary objective - To study of effect of sesame oil shiroabhyanga in the management of palitya.
Secondary objective - To study the conceptual aspects of palitya.
To study the properties of sesame oil.

Methodology -study design 
Screening of subject from population will be done on the basis of inclusive criteria and exclusive criteria.
They will be divided in to 2 groups by computerized random sampling method after taking concent.

Group A- 80 individuals will be given sesame oil shiroabhyanga upto 15 minutes.
Follow up at D-15 and after study D-180

Then Assessment will be done by objective and subjective parameters before and after study and subjective parameters onD+
0,D-15,D-30,D-45,D-60,D-75,D-90,D-105,D-120,D-135,D-150,D-165,D-180.

Statistical analysis with appropriate test and interpretation will be done.

Study population - on the basis of clinical examination and history total individual will be selected according to their eligibility criteria.
Group A- 80 individuals will be given seasme oil shiroabhyanga.
Group B - 80 individuals will be given hair care counselling.

Inclusive criteria - 
1. Age group 18-45 years.
2. Irrespective of their Sex and socioeconomic status.
3. Subjects having signs of palitya.
4. Subject ready to give informed consent.

Exclusive criteria -
1. Subjects having history of any general systemic illness.
2. Subjects on any other medications.
3 ANC women and Lactating mothers.
4. patients having chronic disease and genetic disorder like albinism.

Withdrawal Criteria -
1. Occurance of adverse effect during study.
2. Subjects who are not giving follow up.
3. Subject not willing to continue the trail.
 
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