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CTRI Number  CTRI/2022/10/046160 [Registered on: 04/10/2022] Trial Registered Prospectively
Last Modified On: 27/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [yoga]  
Study Design  Other 
Public Title of Study   To find out the add on effect of selected yoga techniques along with a preparation of bilwa root powder with buttermilk and psychotherapy in insomnia  
Scientific Title of Study   Effect of selected yoga techniques as an adjunct to vilwamoola khala and satwavajaya chikitsa in insomnia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swathi Suresh 
Designation  PG Scholar 
Affiliation  Govt Ayurveda Medical College Thiruvananthapuram 
Address  Pulinhal house PoroorWayanad PO Thalappuzha via Wayanad
Department of Swasthavritta Government Ayurveda Medical College Thiruvananthapuram
Thiruvananthapuram
KERALA
670644
India 
Phone  9048205195  
Fax    
Email  swathisuresh903@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Swathi Suresh 
Designation  PG Scholar 
Affiliation  Govt Ayurveda Medical College Thiruvananthapuram 
Address  Pulinhal house PoroorWayanad PO Thalappuzha via Wayanad
Department of Swasthavritta Government Ayurveda Medical College Thiruvananthapuram

KERALA
670644
India 
Phone  9048205195  
Fax    
Email  swathisuresh903@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayan D 
Designation  Professor 
Affiliation  Govt Ayurveda Medical College Thiruvananthapuram 
Address  Sreeparnika JNRA 59A Jawahar Jn Pattathanam Kollam
Department of Swasthavritta Government Ayurveda Medical College Thiruvananthapuram
Thiruvananthapuram
KERALA
691021
India 
Phone  9447104383  
Fax    
Email  dr.jayan.d@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College Thiruvananthapuram  
 
Primary Sponsor  
Name  Swathi Suresh 
Address  Swathi Suresh PG Scholar Department of Swasthavritta Government Ayurveda Medical College Thiruvananthapuram  
Type of Sponsor  Other [Government Ayurveda Medical College ,Thiruvananthapuram] 
 
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 
Swathi Suresh  Government Ayurveda Medical College Thiruvananthapuram   OPD 2 Department of Swasthavrita Government Ayurveda Panchakarma Hospital Poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA 		 9048205195

swathisuresh903@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee(IEC), Government Ayurveda College Thiruvananthapuram Kerala India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH निद्रानाशः/अस्वप्नः,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Yoga, satvavajaya chikitsa (Procedure Reference: Hatayogapradeepika, Procedure details: Prayer, Loosening Exercise -once ï‚· Tadasanam, Vrikshasanam,Padmasanam Vajrasanam, Padahastasanam, Ardhakatichakrasana Sashankasanam, Bhujangasanam, Shalabasana Matsyasanam, Nadisudhi Pranayamam, Bhramari Pranayama Sheetali Pranayamam- twice daily ï‚· Deep Relaxation in Shavasana, Aum Kar -once Duration -1month;1hour daily)
(1) Medicine Name: Vilwa moola choornam, Reference: Chikitsamanjari, Route: Oral, Dosage Form: Not Applicable, Dose: 75(ml), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants having difficulty in initiating and maintaining sleep. 
 
ExclusionCriteria 
Details  1. Participants with known severe systemic illness and other neurological illness.
2. Pregnant and lactating women 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pittsburgh sleep quality index  0th,31th and 46th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   10/10/2022 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Insomnia is a major public health problem and is the most common sleep disturbance in both adults and children. It is the difficulty in initiating and maintaining sleep or both, or the perception of poor sleep quality, in which the patient’s physical, psychological and social activities are interfered with, by a strong feeling of sleep deficiency upon waking in the morning. Insomnia is one among the 7 categories of sleep disorders in the International Classification of Sleep Disorders-3(ICSD-3(2020)).
In Ayurveda, nidra has been given prime importance and hence included in the tripods of life. So alteration in the natural process of nidra has a huge impact on the life processes as well. These alterations include nidranasa (complete loss of sleep), alpanidra (partial loss of sleep), nidradhikya (excess sleep) etc. Nidranasa, alpanidra, nidradhikya are vata, pitta, kapha nanatmaja vyadhis respectively. Clinical studies have proven the effect of use of vilwamoola khala and satwavajaya chikitsa as well as yoga in insomnia. This study is done with an intention to find out their add on effect.
 A Quasi experimental study will be conducted in 60 participants of age group 20-60 years, satisfying the inclusion and exclusion criteria. Out of 60 participants, 30 will be consecutively selected and alternately allocated to study group (group 1) and control group (group2) . In Group 1 selected yoga techniques along with use of vilwamoola khala and satwavajaya chikitsa are done in insomnia. In Group 2, only use of vilwamoola khala and satwavajaya chikitsa are advised. The study period is for 30 days. Assessment will be done on 0th, 31st and 46th day using Pittsburgh sleep quality index & data analyzed accordingly.
 

 
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