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CTRI Number  CTRI/2024/10/075493 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Cliical trial to study the effect of 2 procedures Shirodhara and Shiroabhyangam with Akshanga taila in patients with Stress induced Insomnia. 
Scientific Title of Study   To evaluate the effect of Shirodhara and Shiroabhyanga with Akshanga Taila in Nidranasha with special reference to Stress Induced Insomnia - a Randomized Comparative Clinical Study. 
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. SUDHEESH K 
Designation  PG Scholar 
Affiliation  Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.) 
Address  Dept. of Post Graduate Studies in Panchakarma, Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.)

Uttara Kannada
KARNATAKA
581355
India 
Phone  9400111993  
Fax    
Email  sudheeshkrishnan24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MAHALAKSHMI K M 
Designation  Reader 
Affiliation  Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.) 
Address  Dept. of Post Graduate Studies in Panchakarma, Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.)

Uttara Kannada
KARNATAKA
581355
India 
Phone  9900979629  
Fax    
Email  drmahalakshmi15@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MAHALAKSHMI K M 
Designation  Reader 
Affiliation  Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.) 
Address  Dept. of Post Graduate Studies in Panchakarma, Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.)

Uttara Kannada
KARNATAKA
581355
India 
Phone  9900979629  
Fax    
Email  drmahalakshmi15@gmail.com  
 
Source of Monetary or Material Support  
Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.) KARNATAKA, PIN:581355, INDIA 
 
Primary Sponsor  
Name  Dr SUDHEESH K 
Address  P.G Scholar, Dept. of Post Graduate Studies in Panchakarma, Dhanvantari Ayurveda College Hospital And Research Centre Siddapur (U.K.) Karnataka INDIA 
Type of Sponsor  Other [] 
 
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 Sudheesh K  Dhanvantari Ayurveda College Hospital and Research Centre Siddapur (U.K.)  Dept.of Post Graduate Studies in Panchakarma, Siddapur (U.K.) Karnataka,INDIA PIN:581355
Uttara Kannada
KARNATAKA 		 9400111993

sudheeshkrishnan24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Dhanvantari Ayurveda College and Research Centre, Siddapur - 581355 (U.K.)  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-SiraHsekaH, शिरःसेकः (Procedure Reference: ASHTANGA HRIDAYA, Procedure details: GROUP A - SHIRODHARA WITH AKSHANGA TAILA 2 litres of Akshanga taila will be made luke warm in the hot water bath. Indicated patient of Nidranasha as per inclusion criteria will be selected for the procedure. Shirodhara will be done with luke warm Akshanga taila externally with 4 angula height above forehead by using dhara patra with uniform flow in a continuous swinging movement side wards. After the procedure patient will be asked to take rest for 15mins and will be advised to take luke warm water shower. This will be done for 30min in the evening between 5 pm to 7pm for 14 Days )
(1) Medicine Name: AKSHANGA TAILA, Reference: AROGYA KALPADRUMAM, Route: Topical, Dosage Form: Taila, Dose: 3000(ml), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: ASTANGA HRIDAYAM, Procedure details: GROUP B - SHIROABHYANGAM WITH AKSHANGA TAILA 30 ml of Akshanga taila will be made luke warm in the hot water bath. Indicated patient of Nidranasha as per inclusion criteria will be selected for the procedure. Akshanga taila which is made luke warm will be applied on the whole scalp. Then the procedure will be carried out by using different massaging techniques like Anguli kreeda (finger strokes), Mrudumushti (pressure strokes), Nishpeeda (petrissage), Tala tadana (tapotement), Kampana hastha (vibration), Marma tadana (marma massage), Kesha lunchana ( hair tugging ) and Ghatita hastha (compression) for 30 minutes. After the procedure patient will be asked to take rest for 15mins and will be advised to take luke warm water shower. This will be done for 30min in the evening between 5 pm to 7pm for 14 Days )
(1) Medicine Name: AKSHANGA TAILAM, Reference: AROGYAKALPADRUMAM, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patiets having classical symptoms of nidranasha mentioned in ayurveda samhitas(akshigaurava , shirogaurava,jrumbha , tandra , alasya) and who are fit for shirodhara and shiroabhyangam.
sleep efficiency index less than 85%.
Patiets with disturbed sleep since 1 month are included.
 
 
ExclusionCriteria 
Details  Patients on anti psychiatric medicines.
sutika and Garbhini.
Nidranasha associated with known case of cardiac diseases,hypertension,paralysis and neurological disorders.
undergone recent head surgery 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in sleep  0th day before treatment,7th day during treatment and 14th day after treatment.
follow up on 21 st day and 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in symptoms like angamarda,akshigaurava,shirogaurava,jrumbha,tandra and alasya  0th day before treatment,7th day during treatment and 14th day after treatment.
follow up on 21 st day and 28th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/11/2024 
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="0"
Days="0" 
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  

40 patients having stress induced insomnia will be selected randomly from OPD, referrals and special camps conducted by DHANVANTARI AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE SIDDAPUR (U.K.) fulfilling the inclusion criteria and exclusion criteria of Nidranasha and equally divided into 2 groups 20 each in Shirodhara with Akshanga taila and Shiroabhyanga with Akshanga taila.

A detailed proforma will be prepared for the assessment of subjective and objective parameters

by grading them. The data obtained will be analysed statistically with suitable method.

 

 
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