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CTRI Number  CTRI/2025/11/097406 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Does shirodhara with medicated ksheera of aswagandha churna helps in increasing sleep in persons having sleeplessness aged 20-60  
Scientific Title of Study   A Pilot clinical study to evaluate the effect of Aswagandha Ksheera shirodhara in insomnia disorders w s r to EEG and sleep indices  
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 Sruthi K 
Designation  PG Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda College Thiruvananthapuram Government Ayurveda Panchakarma Hospital Poojappura Kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9746612249  
Fax    
Email  ksruthi676@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sruthi K 
Designation  PG Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda College Thiruvananthapuram Government Ayurveda Panchakarma Hospital Poojappura Kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9746612249  
Fax    
Email  ksruthi676@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ambili Krishna 
Designation  Assistant professor 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda College Thiruvananthapuram Government Ayurveda Panchakarma Hospital Poojappura Kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9847827220  
Fax    
Email  dr.ambilikrishna@gmail.com  
 
Source of Monetary or Material Support  
CCRAS Pg star 61 65 Institutional Area Opp D Block Janakpuri New Delhi 110058 
Department of Panchakarma government Ayurveda college Thiruvananthapuram kerala India 695012  
 
Primary Sponsor  
Name  Dr Sruthi k 
Address  Department of Panchakarma Government Ayurveda College Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura Kerala India 695012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Ccras PG star  Ccras 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sruthi K  Government Ayurveda college PanchakarmaHospital Thiruvananthapuram  OP no 1 Department of Panchakarma Government Ayurveda College Thiruvananthapuram Government Ayurveda Panchakarma Hospital Poojappura Kerala
Thiruvananthapuram
KERALA 
09746612249

ksruthi676@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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: Sirasekadi vidhi , Procedure details: PRADHANA KARMA position the patient to the tip of wick comes 6 to 8 cm above mid portion of forehead Hold the vessel little away from the head Pour lukewarm ksheera in to dhara vessel carefully Bring back dhara vessel above the head Direct the dhara coming through wick in to patients forehead Adjust the size of wick so as to make the size of dhara equal to thickness of small finger of patient Maintain continuos & steady stream Oscillate the vessel with moderate speed from one end of forehead to the other with right hand Maintain uniform rate of oscillation throughout the procedure Do gentle massage over the head frequently with left hand Continue the procedure upto 45 minutes Ask the patient to flex the lower limb occasionally during the procedure )
(1) Medicine Name: Aswagandha , Reference: Ashtanga hridaya , Route: Topical, Dosage Form: Ksheerpaka, Dose: 2000(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants fullfilling the diagnostic criteria
2.Between the age group of 20 to 60 years
3.Participants willing to give informed consent  
 
ExclusionCriteria 
Details  1.Active infections on scalp
2.Allergic rhinitis and fever
3.Insomnia due to substance abuse
4.Taking any medication that could cause sedation and cause insomnia
5.Taking pain killers contain caffeine
6.Psychiatric and epileptic patients with and without medications
7.Other physical signs such as dementia or any space occupying lesion 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the following variables will be noted
1.Insomnia Severity Index 1st
and 15th day
2.Pittsburgh sleep quality
index 1st and 15th day
3.Event Evaluation scale
accessed daily
4.Polysomnography 0th,15 th day 
0th day,15th day in case of sleep indices and polysomnography  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   22/11/2025 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Adequate sleep is one of the essential factors to lead a healthy life. In another words if normal sleep is disturbed for a short time, it can be managed but if it continues for a prolonged period then the condition is called as a disease which can be termed on the basis of its characteristics like sleep disorder, insomnia  etc. The ICSD-3  is built on the same basic outline as the ICSD-2 ,Identifying seven major categories that include insomnia disorders ,sleep related breathing disorders ,central disorders of hypersomnolence, circadian rhythm sleep -wake disorders ,sleep related movement disorders, parasomnias, and other sleep disorders. Insomnia disorder affect large proportion of population on a situational ,recurrent or chronic basis and is among the most common complaints of medical practice, is predominantly characterized by dissatisfaction with sleep duration or quality and difficulties initiating or maintaining sleep, along with substantial distress and impairment of day time functioning In ayurveda it can  be correlated as nidranasha, anidra, etc. Nidra is one among the trayo upastambha, hence it is needed for  normal body function. It is an adharaneeya 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.  Shiro dhara is comes under Murdhini taila.It is a classical and well established ayurvedic procedure of slowly and steadily dripping medicated oil or other liquids on the forehead.There are numerous studies claiming effectiveness in insomnia with ayurveda interventions but the scientific validation remain largely unexplained. The main reason being difficulty to accessing affordable technology The objective of this study is to evaluate aswagandha ksheera shiro dhara in insomnia disorders is effective in inducing EEG changes. As this is a pilot study, A total number of 12 participants having insomnia disorder administrated shirodhara .Pre and post treatment, PSG will be evaluated along with sleep indices

Key words- Shiro dhara, Insomnia disorders, Electro encephalo gram (EEG),Polysomnography (PSG)

 
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