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CTRI Number  CTRI/2021/07/035168 [Registered on: 27/07/2021] Trial Registered Prospectively
Last Modified On: 19/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Lepa(Hair pack) and Nasal oil drops in early greying of Hair 
Scientific Title of Study   Single arm clinical study to evaluate effect of topical use of Ayasadi Lepa with Nimb beej tail Nasya in management of Akal palitya. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nilima Dharkar 
Designation  Professor PG Guide 
Affiliation  Dr D Y Patil college of Ayurved and Research Pimpri 
Address  OPD no.5 Skin OPD division-Rasashaastra Department-Rasashastra and Bhaishajya Kalpna Dr D.Y. Patil College of Ayurved and research centre Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Pune

Pune
MAHARASHTRA
411018
India 
Phone  8390077907  
Fax    
Email  dharkar.nilima07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilima Dharkar 
Designation  Professor PG Guide 
Affiliation  Dr D Y Patil college of Ayurved and Research Pimpri 
Address  OPD no.5 Skin OPD division-Rasashaastra Department-Rasashastra and Bhaishajya Kalpna Dr D.Y. Patil College of Ayurved and research centre Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Pune

Pune
MAHARASHTRA
411018
India 
Phone  8390077907  
Fax    
Email  dharkar.nilima07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nilima Dharkar 
Designation  Professor PG Guide 
Affiliation  Dr D Y Patil college of Ayurved and Research Pimpri 
Address  OPD no.5 Skin OPD division-Rasashaastra Department-Rasashastra and Bhaishajya Kalpna Dr D.Y. Patil College of Ayurved and research centre Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Pune

Pune
MAHARASHTRA
411018
India 
Phone  8390077907  
Fax    
Email  dharkar.nilima07@gmail.com  
 
Source of Monetary or Material Support  
Dr DY Patil college of Ayurved and research Pimpri  
 
Primary Sponsor  
Name  Dr Jyoti Avadhut Mohite 
Address  C702 Rose valley pimple said agar pimpri 411027 pune maharashtra 
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 
Dr Jyoti Avadhut Mohite  Dr D Y Patil college of Ayurveda and Research centre   OPD no.5 Skin OPD division-Rasashaastra Department-Rasashastr a and Bhaishajya Kalpna Dr D.Y. Patil College of Ayurved and research centre Pimpri Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Pune Pune
Pune
MAHARASHTRA 		 8080172047

drjyotirmayi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and recognition committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L678||Other hair color and hair shaft abnormalities. Ayurveda Condition: AKALAPALITAH (KEVALAPITTA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIMB BEEJ TAIL AYASADI LEPA  NIMB BEEJ TAIl Nasya...nasal drops in pratimarsha matra which is dwi bindu(two drops) in each nostril once a day for 28 days LEPA FOR HAIR APPLICATION External hair pack application once a week for four weeks  
Comparator Agent  NOT APPLICABLE  NIL  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  34.00 Year(s)
Gender  Both 
Details  All patients presenting with complaint of premature hair graying
Age 18 to 34
Both male and female subjects
 
 
ExclusionCriteria 
Details  Persons suffering from Significant systemic and chronic diseases
Hair loss greater than Ludwig type I
Any hair or scalp disease at the moment
History of hair dyeing one month previously
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in colour of the hair strands shall be assessed with photopictometry...using a trichoscope...  every week day 7th, 14th, 21th,28th. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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)   05/08/2021 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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)?  

Response - NO
Brief Summary  
These days in era of presentation looks matter a lot and many yongsters are gravely concerned about early graying of Hair...also early graying signifies poor internal health of the individual thus there is a need for treatment parameter for hair graying. Ayurveda advocated Nasya and Lepa alongwith oil application thus this study would be very benefical for the society in general. Rather is need of the hour.  
 
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