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CTRI Number  CTRI/2023/09/057272 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 26/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of nasal drops and head massage with herbal oil in primary insomnia 
Scientific Title of Study   A Clinical Study to evaluate the efficacy of Ksheerbala Taila (Pratimarsh Nasya and Shiroabhyang) in management of Anidra (primary insomnia) 
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 Nupur Rangani 
Designation  MD Scholar 
Affiliation  Post Graduate Institute of Ayurved 
Address  Department of Swasthavritta And Yoga Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  7228873128  
Fax    
Email  nupurspatel29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Pramod Kumar Mishra 
Designation  Proffesor Head of Department of Kayachikitsa 
Affiliation  Post Graduate Institute of Ayurved 
Address  Department of Kayachikitsa Post Graduate Institute of Ayurved 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  Proffesor Head of Department of Kayachikitsaa 
Affiliation  Post Graduate Institute of Ayurved 
Address  Department of Kayachikitsa Post Graduate Institute of Ayurved 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 Jodhpur  
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved 
Address  PG Department of Swasthavritta and Yoga Poat Graduate Institute of Ayurved 
Type of Sponsor  Research institution and hospital 
 
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 Nupur Rangani  Post Graduate Institute of Ayurveda  Department of Swasthavritta and Yoga OPD no 8 Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur
RAJASTHAN 		 7228873128

nupurspatel29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Post Graduate Institute of Ayurved Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Sushrut Samhita Chikitsa sthan 40/52, Procedure details: 2 drops in each nostrils twice a day)
(1) Medicine Name: Ksheerbala taila, Reference: Sahastrayoga, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 45 Days
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charak Samhita Sutra sthan 5/83, Procedure details: Shiro Abhyang with Ksheerbala Taila as per requirement at night )
(1) Medicine Name: Ksheerbala Taila, Reference: Sahastrayoga, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 45 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients ages between 18 to 50 years irrespective of their caste, race and sex
etc
Patient with symptoms of Anidra (primary insomnia)
Anidra with the history of minimum 2 week
Willing to come for regular follow up 
 
ExclusionCriteria 
Details  Patients age below 18 and above 50 years
Volunteers or patients who were suffering from major psychiatric illness, chronic disease and
acute condition were excluded from the study
Patients suffering from other systemic illness and on other medications
Alcoholic drug user and drug dependent were also excluded from the study to achieve better
result
Pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of subjective assessments of symptoms like Jrimbha Tandra Angmarda Shiro Gaurav Jadya Glani Bhrama Apakti in Patient of Primary Insomnia  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
To test the efficacy of Ksheerbala Taila in form of Pratimarsh Nasya & Shiroabhyanga in Primary Insomnia  45 days 
 
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)   15/09/2023 
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="1"
Days="15" 
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 - NO
Brief Summary   An Interventional study will be done on 30 Patients  with administration of Ksheerbala Tail Pratimarsh Nasya (nasal drops) 2 drops in each nostril along with Shiroabhyang with Ksheerbala Tail for 45 days. The patients will be assessed on basis of subjective criteria of primary insomnia (Anidra) before and after trial. Follow up will be taken on every 7th day. The data will be collected and analyzed statistically using appropriate test.
 
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