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CTRI Number  CTRI/2023/08/057133 [Registered on: 31/08/2023] Trial Registered Prospectively
Last Modified On: 25/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study about Ischemic Hemiplegic Stroke patients admitted in NIS  
Scientific Title of Study   Demographic and morbidity profiling of the patients admitted for the management of Ischemic hemiplegic stroke (Pakkavatham) in the IPD of National Institute of Siddha – A Retrospective Observational Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  R.Tamilmuthu 
Designation  PG Scholar 
Affiliation  National Insitute Of Siddha 
Address  Room no 20/21 Department Of Noinaadal, National Institute of Siddha, Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  6384827971  
Fax    
Email  tamilmuthu00023@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  R.Tamilmuthu 
Designation  PG Scholar 
Affiliation  National Insitute Of Siddha 
Address  Room no 20/21 Department of Noinaadal National Institute of Siddha Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  6384827971  
Fax    
Email  tamilmuthu00023@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr GJChristian 
Designation  Professor and Head of the Department 
Affiliation  National Insitute Of Siddha 
Address  Room no 20/21 Department of Noinaadal National Institute of Siddha Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF SIDDHA,TAMBARAM SANATORIUM,CHENNAI 600047 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Research institution and hospital 
 
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 
RTamilmuthu  Ayothidoss Pandithar Hospital  National Institute of Siddha,Tambaram Sanatorium Chennai
Chennai
TAMIL NADU 		 6384827971

tamilmuthu00023@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ï‚·Ischemic hemiplegic stroke patients who had been admitted in the IPD of NIS during JUNE 2005 – JUNE 2023
ï‚·Sex: Both male and Females
ï‚·Ischemic hemiplegic stroke
ï‚·Patients admitted for a period not less than 20 days in IPD. 
 
ExclusionCriteria 
Details  ï‚·Hemorrhagic stroke patients admitted in IPD of NIS. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To document the demographic and morbidity profiling of the patients admitted for the management Ischemic Hemiplegic stroke.
To document the progression of ischemic hemiplegic stroke patients who took siddha medicine in National Institute Of Siddha. 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   07/09/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  


BACKGROUND

Stroke is an acute neurologic injury occurring as a result of vascular pathologic processes which manifest either as brain infarction or haemorrhage. Stroke can be caused by age, obesity, smoking, alcohol, hypertension, dyslipidaemia, heart diseases, etc 2. Stroke is a frequent medical emergency, the burden of which is rising annually 3. In 2019, there were 12.2 million incidence cases of stroke, making it the second leading death causes in the world and third leading cause of disability. Ischemic stroke was the most frequent among incident cases and constituted 62.4% of all stroke 4.

In siddha system of medicine Pakkavatham is one among the 80 vatham disease. It could be correlated with hemiplegia. Hemiplegia is the complete paralysis of one entire of the body.

“உண்மையா யுடம்பெல்லாம் வாயு வாகி

உயர்கின்ற நாடியது அசைவு மின்றிக்

கண்மையாயக் காயமீ தினிலே யேறிக்

கசக்கியே இழிந்துமே வலித்துக் காணும்

பண்மையாய்ப் பக்கத்தி லிசிவு முண்டாய்ப்

பாரித்துப் பணைகக்கையு காலும் கோணும்

வெண்மையா யுடம்பெங்கும் வியர்வை காணும்

மெலிவுபக்க வாதத்தின் விவரந் தானே”

The above verse from yugi vaithya chinthamani – 800 explains the clinical presentation of stroke 5,6.

So far, there are many studies to assess the siddha diagnostic tools and yakkaiyin ilakkanam for stroke (Pakkavatham). Also, there are many studies on siddha internal and external medicines. But there is no study on the documentation of demographic and morbidity details about the patients admitted in IPD, NIS. From this study there will be awareness to the people about the stroke and its improvement by taking siddha medicines. 

OBJECTIVE:

PRIMARY OBJECTIVE:

          To review the demographic and morbidity profiling of the patients admitted for the management of Ischemic hemiplegic stroke in the IPD of National Institute of Siddha.

SECONDARY OBJECTIVE:

      To review the prognosis of ischemic hemiplegic stroke patients admitted in IPD of NIS through Modified Rankin Scale (MRS).

he word siddha comes from the siddhi which means ‘An object to be obtained’ or ‘Perfection’ or ‘Heavenly bliss’. siddhi generally refers to Ahstama siddhi. The eight greats super natural powers which are enumerated as Anima, etc. these who attained or achieved the above said powers are known as siddhars1.


STUDY DESIGN : This is an  retrospective study which be will be carried out for 6 months in Patients with the ischaemic hemiplegic stroke Reporting at IPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai – 600 047 with 5OO patients as sample size. Patients with age ?20 years and ?70 years of Both sex and transgender,Patient having Ischemic hemiplegic stroke patients who had been admitted in the IPD of NIS during JUNE 2005 – JUNE 2023Patients admitted for a period not less than 20 days in IPD will be included in the study. Patients having clinical presentation of Hemiplegic stroke, Patients who are willing to give informed consent will be included in this study. 

OUTCOME:

· The demographic and morbidity profiling of the patients admitted for the management of ischemic hemiplegic stroke.

· The progression of ischemic hemiplegic stroke patients who took siddha medicine in National Institute Of siddha on the bases of reduction of MRS score.

 




 
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