| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| 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 |