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CTRI Number  CTRI/2023/08/056856 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 20/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of herbal Nasal drops and Yogasana in hairfall 
Scientific Title of Study   A Study On The Efficacy Of Shadbindu Tail Pratimarsh Nasya Along With Sarvangasana In Management Of Khalitya 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajni Dabi 
Designation  M D Scholar 
Affiliation  Post Graduation Institute Of Ayurveda 
Address  Department Of Swasthvritta And Yoga Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  7062687856  
Fax    
Email  rajnid812@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Pramod Kumar Mishra 
Designation  Professor Head Of Department Of Kayachikitsa  
Affiliation  Post Graduation Institute Of Ayurveda 
Address  Department Of Swasthvritta And Yoga Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Pramod Kumar Mishra 
Designation  Professor Head Of Department Of Kayachikitsa  
Affiliation  Post Graduation Institute Of Ayurveda 
Address  Department Of Swasthvritta And Yoga Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Kadwad Jodhpur Rajasthan 
 
Primary Sponsor  
Name  Post Graduate Institute Of Ayurveda 
Address  P G Department Of Swasthvritta and Yoga Post Graduate Institute Of Ayurved 
Type of Sponsor  Government 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 Rajni Dabi  Post Graduate Institute Of Ayurveda  Deapartment of Swasthvritta and Yoga OPD No 8 Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur
RAJASTHAN 		 7062687856

rajnid812@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Post Graduate Institution Of Ayurved  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charak Samhita, Procedure details: Two drops given in each nostrils twice a day)
(1) Medicine Name: Shadbindu Tail, Reference: Government Formulary of India, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 3 Months
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 patients aged between 20 to 60 years irrespective of their caste race and sex etc
2 patients having the clinical features of khalitya
3 patients belonging to both genders will be included
4 patient with sign and symptoms of khalitya as mentioned in ayurveds text
5 patients who are using artificial shampoo 
 
ExclusionCriteria 
Details  1 patients aged below 20 and above 60 years
2 patient suffering form any severe systematic disease example cancer
3 necessary steps were taken to exclude other conditions per facilities availablein the institute
4 patients have a history of hair loss due to injury
5 patients have contraindications of sarvangasana as HTN SCIATICA and CERVICAL PAIN
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs & symptoms of khalitya like dry hair, dandruff, itching on scalp, inflammation on scalp.  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of drug on hair loss & hair fall test  12 weeks 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/09/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary   An interventional study will be done on Number of Patient 30 with administration of Shadbindu tail nasya (nasal drops) 2 drops in each nostril along with sarvangasana for three months. The patients will be assessed on basis of subjective and objective criteria of khalitya before and after trial. Follow up will be taken on every 15th day. The data will be collected and analyzed statistically using appropriate test. 

 
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