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CTRI Number  CTRI/2025/10/096516 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   to evaluate the role of shirobasti in stroke syndrome in patients with speech difficulty  
Scientific Title of Study   A CLINICAL STUDY TO EVALUATE THE EFFECT OF SHIROBASTI IN PAKSHAGHATA ASSOCIATED WITH VAK VIKRITI W.S.R TO SPEECH DISABILITIES IN STROKE SYNDROME 
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 Manjunatha N 
Designation  PG SCHOLAR 
Affiliation  SDM COLLEGE OF AYURVEDA KUTHPADY UDUPI 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre Kuthpady
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady
Udupi
KARNATAKA
574118
India 
Phone  09980550567  
Fax    
Email  manjunathn452000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajalakshmi M G 
Designation  professor  
Affiliation  SDM COLLEGE OF AYURVEDA AND HOSPITAL UDUPI 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady
Udupi
KARNATAKA
574118
India 
Phone  9448951673  
Fax    
Email  drrajalaxmisdm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjunatha N 
Designation  2nd year pg scholar  
Affiliation  SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE UDUPI 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady
Udupi
KARNATAKA
574118
India 
Phone  09980550567  
Fax    
Email  manjunathn452000@gmail.com  
 
Source of Monetary or Material Support  
Dr Manjunatha N 2nd year pg scholar department of panchakarma Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady Udupi 
 
Primary Sponsor  
Name  dr manjunatha n 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady Udupi 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nill  nill 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjunatha N  sri dharmasthala manjunatheswara college of ayurveda hospital and research centre   Department of pg studies in panchakarma General OPD 9 and IPD SDM college of ayurveda hospital and research centre
Udupi
KARNATAKA 
9980550567

manjunathn452000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICAL CLEARANCE COMMITTEE - HUMAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Comparator Agent  not applicable   not applicable  
Intervention  prasarini taila  shirobasti in stroke syndrome 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  stabilized Patients of known case of Pakshaghata stroke
Within the chronicity of 3 years
Patients aged between 16 70 years
Patients fit for Shirobasti 
 
ExclusionCriteria 
Details  History of cognitive or behavioural complaints• History of psychiatric illness, dementia, hearing impairment, drug abuse and severe alcoholismand other systemic illness• Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of shirobasti in treating vak vikriti in pakshagatha w s r aphasia and dysarthria  7 days  
 
Secondary Outcome  
Outcome  TimePoints 
to improve Vak sanga ,Mooka Gadgada vak Minmina vak
Deena vak Jihma vak Samukshipta vak Kala vak  
7 days  
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/11/2025 
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="1"
Months="1"
Days="25" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Globally stroke is the second leading cause of death and third leading cause of disability and one in four people are in danger of stroke in their lifetime. Annually 15,000,000 people worldwide suffer a stroke, Out of these 5 million die and another 5 million are left permanently disabled placing a burden on family and community 

Stroke carries a high risk of death and survivors can experience loss of vision and or speech, paralysis and confusion. Patients who become paralyzed following a stroke need a special care to help them to recover and to avoid complications and long-term disabilities and this disease is with close resemblance with the disease Pakshaghata in Ayurveda. 

The term Pakshagata denotes specific variety of Vatavyadhi which is caused predominantly by Vata dosha. The term Pakshagata literally means paralysis of one half of the body characterised by impairment of motor and sensory activity and loss/impairment of speech. 

Speech impairment whether aphasia or dysarthria are a common consequences of stroke.  A study showing 64% of the 88,974 stroke survivors with speech impairment where 28% had both aphasia and dysarthria, 24% had dysarthria only and 12% had aphasia only

Murdhni taila is one among the bahya snehana procedure where in the oil is applied over shiras in different manner. And shirobasti is one among the murdhnitaila which is considered as superior one among all 4 types where in a pool of oil is poured over shiras for a certain period of time . And this shirobasti can be considered as one of the safest and effective procedure done in treating Pakshaghata

 
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