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CTRI Number  CTRI/2025/02/080214 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Study to compare the efficacy of Yashtimadhu Taila Shirodhara with Yoga Nidra in Chronic Insomnia  
Scientific Title of Study   Randomized Cross over Clinical Study on Efficacy of Yashtimadhu Taila Shirodhara and Yoga Nidra in Chronic 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 Samruddhi Vaidkar 
Designation  M D PG Scholar Panchakarma 
Affiliation  Dr. D. Y. Patil College of Ayurved and Research Centre 
Address  OPD No 9 Panchakarma Department Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9922898753  
Fax    
Email  wbddg123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pranesh Gaikwad 
Designation  M D Panchakarma 
Affiliation  Dr. D. Y. Patil College of Ayurved and Research Centre 
Address  OPD No 9 Panchakarma Department Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  8668259365  
Fax    
Email  pranesh.gaikwad@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pranesh Gaikwad 
Designation  M D Panchakarma 
Affiliation  Dr. D. Y. Patil College of Ayurved and Research Centre 
Address  OPD No 9 Panchakarma Department Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  8668259365  
Fax    
Email  pranesh.gaikwad@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. D.Y.Patil College of Ayurved and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 
 
Primary Sponsor  
Name  Dr Samruddhi Vaidkar 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 India 
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 Samruddhi Vaidkar  Dr. D. Y.Patil. College of Ayurved and Research Centre   OPD No 9 Department of Panchakarma Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 India
Pune
MAHARASHTRA 		 9922898753

wbddg123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr DYPCA and RC Institutional Ethics Committee Pimpri Pune  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-Shirodhara (Procedure Reference: 3. S. Sharma; Dharakalp; Chaukhamba publication; Page No. 23., Procedure details: Yashtimadhu Taila Shirodhara will be done for 30 min each day for 7 days)
2Comparator ArmProcedure-Yoga Nidra (Procedure Reference: Datta K, Tripathi M, Verma M, Masiwal D, Mallick HN. Yoga nidra practice shows improvement in sleep in patients with Chronic Insomnia: A randomized controlled trial. National Medical Journal of India. 2021 May, Procedure details: Yoga Nidra will be done for 30 min for 7 days)
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with Chronic Insomnia as per Insomnia DSM-5-TR- Criteria.
2.Patients with symptoms of Angamarda, Jrumbha, Shirogaurav, Glani, Klama.
 
 
ExclusionCriteria 
Details  1.Known cases of Bipolar disorder or Schizophrenia.
2.Patient with medical conditions known to significantly impact sleep quality or require specialized treatment e.g. sleep apnea, restless leg syndrome, chronic pain disorders.
3.Patients using prescribed sleep medications or over the counter sleep aids.
4.Patient with history of substance abuse or dependence.
5.Shift workers.
6.Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in sleep quality, sleep duration, awakenings during night by using Athens Insomnia Scale before and after treatment.
2.Reduction in symptoms of Angamarda or Shirogaurav or Glani or Klama or Jrumbha.
 		 24 days 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate & compare the reduction in symptoms of Angamarda or Shirogaurav or Glani or Klama or Jrumbha.
 		 24 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/03/2025 
Date of Study Completion (India) 29/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included wbddg123@gmail.com).

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is a Randomized Cross over Clinical Study on Efficacy of Yashtimadhu Taila Shirodhara and Yoga Nidra in Chronic Insomnia.

Total 40 patients will be enrolled.

      Yashtimadhu Taila Shirodhara and Yoga Nidra therapies will be given to 20 patients each for 7 days.

·     After washout period of 10 days, crossover will be done and Yashtimadhu Taila Shirodhara and Yoga Nidra therapies will be given to 20 patients each for 7 days.

·     Follow up on 8th, 18th  and 25th day of the patient will be done.


 
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