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CTRI Number  CTRI/2021/01/030503 [Registered on: 15/01/2021] Trial Registered Prospectively
Last Modified On: 07/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [FOOT MASSAGE AND PRANAYAMA]  
Study Design  Single Arm Study 
Public Title of Study   Effect of footmassage along with Pranayama in disturbed Sleep 
Scientific Title of Study   An open labelled single arm clinical study on combined effect of Padabhyanga and Pranayama in Nidranasha(Primary insomnia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR AKSHAY B HIREMATH 
Designation  PG Student 
Affiliation  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Hassan 573201 Karnataka

Hassan
KARNATAKA
573201
India 
Phone  7483968685  
Fax    
Email  akshaybh297@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR AKSHAY B HIREMATH 
Designation  PG Student 
Affiliation  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Hassan 573201 Karnataka

Hassan
KARNATAKA
573201
India 
Phone  7483968685  
Fax    
Email  akshaybh297@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR AKSHAY B HIREMATH 
Designation  PG STUDENT 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL 
Address  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL BM ROAD THANNIRUHALLA HASSAN KARNATAKA 573201

Hassan
KARNATAKA
573201
India 
Phone  7483968685  
Fax    
Email  akshaybh297@gmail.com  
 
Source of Monetary or Material Support  
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Dept of swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Thanniruhalla BM Road Hassan Karnataka 573201 
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 Gurubasavaraj yalagachin  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital   Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hopsital Bm Road Thanniruhalla Hassan Karnataka 573201
Hassan
KARNATAKA 		 9964620229

yogaayu.guru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL,HASSAN  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  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Pranayama and padabhyanga in nidranasha  Foot Massage with tila taila for 10 minutes at bed time and set of pranayama for 1 hour at mmorning for 30 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age between 20 to 70 years
2. Who are willing to participate.
3. Mild to moderate grading of scale 
 
ExclusionCriteria 
Details  1. Subjects indulged in night shift jobs
2. Subjects addicted to tobacco and alcohol.
3. Known case of systemic disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The combined effect of Padabhyanga and Pranayama in Nidranasha  Baseline , 15th day and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
IMPROVED QUALITY OF SLEEP  Baseline, 15th day and 30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2021 
Date of Study Completion (India) 14/02/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included akshaybh297@gmail.com).

  6. For how long will this data be available start date provided 31-03-2022 and end date provided 31-03-2027?
    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  
NAME OF THE DEPARTMENT- DEPARTMENT OF SWASTHAVRITTA 
 
NAME OF THE STUDENT- Dr. AKSHAY B HIREMATH 
NAME OF THE GUIDE- Dr. GURUBASAVARAJ. YALAGACHIN MD (AYU) 
TITLE OF THE STUDY-   
 AN OPEN LABELLED SINGLE ARM CLINICAL STUDY ON COMBINED EFFECT OF PADABHYANGA AND PRANAYAMA IN NIDRANASHA 
SUMMARY- 
Sleep is one of the most significant human behavior, occupying roughly one third of human life. 
It is the state of mind during which it blocks all the perception from the external world. Qualitative 
sleep is the essential component of good health. Disturbed sleep leads to discomfort and diseases, 
can be identified as longer time taken to fall asleep, more periods of wakefulness during the night, 
and time spent lying awake before rising in the morning. . The reported prevalence of insomnia is 
33% in the general population globally ,and 16% in india and18.6% in south india. 
Most commonly recommended tranquilisers and sedatives for the treatment of insomnia are associated with plethora of adverse effects such as confusion, psychomotor performance deficits, nocturnal falls, dysphoric mood, impaired intellectual functioning, muscle weakness and even coma. 
 Nidra being called as AdharaneeyaVega is also emphasized as sub pillar of human life as per Ayurveda purview. It is the special state of mind in which absolute detachment of all Indriyas from Bahya Vishayas due to tiredness in body and mind. Padabhyanga as a part of Dinacharya is said to induce sound sleep and Pranayama not only enhances Pranashakti but also calms down the stress on body and mind. Hence in the current study, the combined effect of Padabhyanga&Pranayana practice among elderly population is attempted as remedial measures. 
 
OBJECTIVES- 
TO evaluate the combined effect of padabhyanga and pranayama in nidranasha 
METHODOLOGY: Interventional clinical study  
INTERVENTION: 
1.Padabhyanga                                           :  20-25 ml of TilaTaila is used for Padabhyanga at bed time. 
   Pranayama                                               : 
1.A,U,M, OM  Chants- 10 times each 
 2. Loosening exersises 
3.Anulomana,vilomana each 10 times 
4.Nadishuddhi pranayama 10 times 
 5. SheetaliPranayama     10 times 
6. SheetkariPranayama   10 times 
7.Bhramari pranayama    10 times 
 8.Shantimantra 
Time for pranayama                               :  Morning 
 Duration                                                 :   30 DAYS 
Follow up during the treatment             :  15th  AND 30th  
Follow up after the treatment                :   Nil  
 
RESEARCH DESIGN 
In the present study 30 patients fulfilling the criteria for inclusion will be selected with convenience sampling technique. The selected patients will be open label single arm interventional study. 
 
 SOURCE OF DATA  
• Subjects from OPD /IPD of SDM Ayurveda Hospital Hassan  • Residents of old age homes of Hassan  
 
 
SAMPLING TECHNIQUE: Convenient sampling  method and treated in single group. 
A) SAMPLE SIZE: 30.  
DIAGNOSTIC CRITERIA: 
1.Guidelines mentioned in ICD-10 will be followed:  
a) A complaint of difficulty in falling asleep, maintaining sleep, or non-refreshing sleep.  
b) The sleep disturbance occurs at least three times per week for at least one month.  c) The sleep disturbance results in marked personal distress or interference with       personal functioning in daily living.          2. For diagnosis, detailed medical history will be taken according to both Ayurvedic and   
  Modern clinical methods.                
 
 
 
 
ASSESSMENT CRITERIA 
Subjective parameters: 
  Sl/no Parameters/lakshana Yes / No 
1.  Jrumbha  
2.  Angamarda  
3.  Tandra  
4.  Akshigourava  
5.  Shirogourava  
 
Objective parameters 
 will be made on basis of assessment criteria developed and validated scale (insomnia severity index) on 0,15 and 30 day of treatment.15. 
0–7 = No clinically significant insomnia.  8–14 = Sub threshold insomnia  15–21 = Clinical insomnia (moderate severity)  
22–28 = Clinical insomnia (severe) 
INCLUSION CRITERIA 
1 Age between 20 to 70 years 
2. Who are willing to participate. 
3. Mild to moderate grading of scale 
Exclusion Criteria: 
1. Subjects indulged in night shift jobs 
2. Subjects addicted to tobacco and alcohol 3. Known case of systemic diseases 
 
 
 
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