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CTRI Number  CTRI/2024/06/069602 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparing the effect of head massage done in traditional and Tiruka method with ksheerabala taila in non-organic insomnia 
Scientific Title of Study   A comparative clinical study on shiro abhyanga done in conventional and Tiruka method with ksheerabala taila in non-organic 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 Devu S Vijayan 
Designation  P G Scholar, Department of Panchakarma 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9400615128  
Fax    
Email  devusvijayan95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devu S Vijayan 
Designation  P G Scholar, Department of Panchakarma 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9400615128  
Fax    
Email  devusvijayan95@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ambili Krishna 
Designation  Assistant Professor, Department of Panchakarma  
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9847827220  
Fax    
Email  dr.ambilikrishna@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and hospital, Thiruvananthapuram 
 
Primary Sponsor  
Name  Dr Devu S Vijayan 
Address  PG Scholar, Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram 695001 
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 Devu S Vijayan  Government Ayurveda College Panchakarma Hospital  Department of Panchakarma, OP NO:1, Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram 695012
Thiruvananthapuram
KERALA 
9400615128

devusvijayan95@gmail.com 
 
Details of Ethics Committee
Modification(s)  
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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Ashtanga hridaya sutrasthana 22/23-24, Procedure details: Luke warm oil is massaged on the scalp & keep it for 45 mins)
(1) Medicine Name: Ksheerabala taila, Reference: Ashtanga hridaya chikitsa sthana 22/45-46, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Raghavendra Swamiji ed.Anga Mardana by Tiruka;rpt edn. Malladi Halli: Sarvodaya Mudranalaya,;1983; 2nd chapter.p.52, Procedure details: Shiro abhyanga is done following 9 strokes with each form of stroke is continued for about 5 minutes, & thus the whole process of head massage takes about 45 minutes. The 9 strokes are as follows • Smearing of oil 1. Gharshana hasta 2. Mridvanguli tadana 3. Dwi hasta tadana 4. Taranga hasta 5. Anguli kreedana hasta 6. Mridu mushti tadana 7. Squeeze strokes 8. Ghatita hasta 9. Ear massage)
(1) Medicine Name: Ksheerabala taila, Reference: Ashtanga hridaya chikitsa sthana 22/45-46, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants fulfilling the diagnostic criteria.(which is:(a)The complaint is either of difficulty falling asleep or maintaining sleep, or of poor quality of sleep.
(b)The sleep disturbance has occurred at least three times per week for at least 1 month.
(c)There is preoccupation with the sleeplessness and excessive concern over its consequences at night and during the day.
(d)The unsatisfactory quantity and/or quality of sleep either causes marked distress or interferes with social and occupational functioning)
2.Between the age group of 20 to 60 years.
3.Participants willing to give informed consent.
4.Those who are fit for the application of Ksheerabala taila on scalp (Prior application of Ksheerabala taila over scalp for 3 days to rule out any adverse results)
 
 
ExclusionCriteria 
Details  1.Active infections on scalp.
2.Allergic rhinitis and fever.
3.Non-organic insomnia due to substance abuse.
4.Taking any medication that could cause sedation.
5.Psychiatric and epileptic patients with and without medication
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
changes in quality of sleep analyzed by Insomnia severity index, Visual Analogue Scale, Pittsburgh sleep quality index scale and Event evaluation scale   0th day, 8th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   N/A 
Date of First Enrollment (India)   09/07/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Non organic insomnia is a condition where there is difficulty in the initiation and maintenance of sleep, atleast 3 times in a week for minimum 1 month period, which results in a marked distress in social and occupational functioning, with an absence of any causative organic factor. In ayurveda it can be correlated as nidranasha, anidra, etc.  It is an adaaraneeya vega and for the management of disease due to suppression of  the urge of sleep, one should resort to sound sleep and massage. Nidranasha is a vataja nanatmaja vikara, mainly caused by vata dosha, in which Murdhni taila is mentioned as one of its treatment. Murdhini taila consist of four different procedures such as abhyanga, seka, pichu and vasti. As per the Textbook of angamarda by Tiruka, the author has described about 26 steps of massage out of which 6 steps are exclusively meant for shiro abhyanga. Later these are incorporated by recent author Dr Srinivasa Acharya  and is summarized as 9 steps. In conventional method these step wise protocol is not followed. In Charaka Samhita it is mentioned that Shiro abhyanga helps to prevents headache, gives strength to skull, strengthens hair root, nourishes sense organs, softens skin, provides lustre to face and one gets good sleep.

Since there are 2 methods available for shiro abhyanga a study is planned to analyze which method is more effective. 30 participants satisfying the inclusion criteria will be selected from the OPD of Govt. Ayurveda Panchakarma Hospital, Poojappura and will be divided into different strata according to severity of insomnia and will be randomly allocated to the two groups (fifteen in each group). In group A we are doing the procedure in conventional method and in group B Tiruka method, till attaining vyadhi samana or for a maximum of 7 days. Assessments will be done before treatment and after treatment using Insomnia severity index, Visual Analogue Scale and Pittsburgh Sleep Quality Index. Data obtained will be statistically analyzed using appropriate tests based on whether it follows a normal distribution curve or not and will be presented in the form of a dissertation
 
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