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CTRI Number  CTRI/2022/03/041211 [Registered on: 21/03/2022] Trial Registered Prospectively
Last Modified On: 21/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   "A Comparative and Clinical Study of Nasya with Yastimadhukadhi Taila and Shubhdeep Hairgrow Oil in the management of Hairfall(Alopecia)”. 
Scientific Title of Study   "A Comparative and Clinical Study of Nasya with Yastimadhukadhi Taila and Shubhdeep Hairgrow Oil in the management of Khalitya (Alopecia)”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravindra Bhati 
Designation  Post Graduation Scholar 
Affiliation  Shubhdeep Ayurved Medical College 
Address  Shubhdeep Ayurved Medical College Datoda indore
Datoda indore
Indore
MADHYA PRADESH
452020
India 
Phone  9893555278  
Fax    
Email  ranubhati@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A K Singh  
Designation  Professor 
Affiliation  Shubhdeep Ayurved Medical College Datoda indore 
Address  Shubhdeep Ayurved Medical College Datoda indore
Shubhdeep Ayurved Medical College Datoda indore
Indore
MADHYA PRADESH
452020
India 
Phone  9300681233  
Fax    
Email  doctoraksingh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr A K Singh  
Designation  Professor 
Affiliation  Shubhdeep Ayurved Medical College Datoda indore 
Address  Shubhdeep Ayurved Medical College Datoda indore
Shubhdeep Ayurved Medical College Datoda indore
Indore
MADHYA PRADESH
452020
India 
Phone  9300681233  
Fax    
Email  doctoraksingh@yahoo.com  
 
Source of Monetary or Material Support  
Shubhdeep Ayurved Medical College Datoda indore 
 
Primary Sponsor  
Name  Shubhdeep Ayurved Medical College  
Address  Shubhdeep Ayurved Medical College Datoda indore 
Type of Sponsor  Private medical college 
 
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 Ravindra Bhati  Shubhdeep Ayurved Medical College Datoda indore  Panchkarma OPD Shubhdeep Ayurved Medical College Datoda indore
Indore
MADHYA PRADESH 		 9893555278

ranubhati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethical Committee Shubdeep Ayurved Medical College indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:4||Measurement and Monitoring. Ayurveda Condition: Khalitya,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: SHUBHDEEP HAIR GROW OIL, Reference: NA, Route: Nasal, Dosage Form: Taila, Dose: 16(drops), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 1 Weeks, Reference: NA, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Yastimadhukadi taila in management of Khalitya, Reference: chakrapanidatta cha.chi. 55/111, Route: Nasal, Dosage Form: Taila, Dose: 16(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: -dose as per ayurvedic text snehan nasya madhyam mantra
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details   Patients of 20 to 40 year age group.
 Patients of both sex, religion and occupation with complain of Khality 
 
ExclusionCriteria 
Details   Patients less than 20 and more than 40 year age.
 Patient suffering from systemic illness likes HIV, Diabetes
Mellitus, Taking chemotherapy and Radiation etc.
 Drug induced hair fall.
 Patient having hereditary history of baldness.
 Patient having hair loss due to injury/operation. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Relief in Hair Fall
2 Relief in Roughness
3 Relief in Splitting of hair ends
4 Relief in Fragility
5 Relief in Dandruff  		 8 weeks (60 days) 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   05/04/2022 
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="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
A comparative and clinical study of nasya with hasti madhukar hi tail and shubh deep hai throw oil in the management of khalitya it is an open clinical study 40 patients of khalitya they were divided in to groups as A and B each having 20 patients group A patients where subjected to yastimadhukadhi taila Nasya groups and group B patients where subjected to shubhdeep hairgrow oil Nasya and as internal medicine attending from OPD and IPD of Shubhdeep Ayurved Medical College and Hospital , indore will be enrolled and examined clinically and pathologically and data of selected patients will be recorded in C.R.F.
 
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