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CTRI Number  CTRI/2021/12/038932 [Registered on: 27/12/2021] Trial Registered Prospectively
Last Modified On: 26/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational Study 
Study Design  Single Arm Study 
Public Title of Study   Observation of different Panchakarma treatments in Paralysis 
Scientific Title of Study   Evaluation of efficacy of panchakarma treatment protocol in pakshaghata (post stroke) –an observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NOT APPLICABLE  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sai Anuhya Velagapudi 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs SHri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  7259495460  
Fax    
Email  anu.vsa13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep L Gramapurohit 
Designation  Professor and HOD 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964144197  
Fax    
Email  drpradeeplg.kaher@kleayurworld.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep L Gramapurohit 
Designation  Professor and HOD 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964144197  
Fax    
Email  drpradeeplg.kaher@kleayurworld.edu.in  
 
Source of Monetary or Material Support  
Dr Sai Anuhya Velagapudi 
 
Primary Sponsor  
Name  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs SHri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NOT APPLICABLE  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sai Anuhya Velagapudi  KLE Ayurveda Hospital  OPD no 04 and IPD Department of Panchakarma KLE Ayurveda Hospital and Research center Belagavi 590003
Belgaum
KARNATAKA 
7259495460

anu.vsa13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Cpmmittee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Not Applicable (Procedure Reference: Not Applicable, Procedure details: Not Applicable)
2Comparator ArmProcedure-Not Applicable (Procedure Reference: Not Applicable, Procedure details: Not Applicable)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients presenting with classical signs and symptoms.
Pakshaghata after acute stage
Either Gender
Patients aged between 30 – 70 years.
Fit for panchakarma.
Diagnosed case of Pakshaghata.
 
 
ExclusionCriteria 
Details  Pakshaghata complicated with heart disease.
Pakshaghata secondary to neoplasms
H/O intra cranial infections – encephalitis, meningitis
Trauma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Panchakarma treatments are efficacious in Pakshaghata  Oth day and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
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   N/A 
Date of First Enrollment (India)   03/01/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Globally, the incidence of noncommunicable diseases is on the rise, drawing attention for its prevention and treatment. Hemiplegia is one among them, causing physical and mental instabilities. Its prevalence is about 9 cases/1000 in the global population. Worldwide, cerebrovascular accidents (stroke) are the second leading cause of death and the third leading cause of disability1. Hemiplegia is a condition of total or partial paralysis of one side of the body, with numbness in limbs, slurred speech, etc., Cerebrovascular accidents such as thromboembolism and haemorrhage of cerebral arteries are the major cause for this condition. This presentation is akin to a condition called Pakshaghata in Ayurveda (Ch. Chi. 28/53). As it is explained by Acharya Madhava, “saadhyam anyen samyukatam”2 means Pakshaghata along with other dosha is easily curable.

The Commonest cause of Hemiplegia is Cerebral Vascular Accident (CVD) or Stroke.

The worldwide incidence has been quoted as 2 in 1000 population per annum, about 4 in 1000 population aged 45-84 years3.

 

 The prevalence of stroke in India shows a huge variation of 142-922/1,00,000 across the diverse community-based studies. 85% of stroke cases are due to cerebral infarction, 15% are due to cerebral haemorrhage and 1.5 times more often in male than in female4.

 

Taking all the above points into consideration, its poor prognosis and nature of inertia, the disease was selected, to find a measure that could help in restoring quality of life in paralyzed patients.

 
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