| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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) |