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CTRI Number  CTRI/2021/01/030211 [Registered on: 04/01/2021] Trial Registered Prospectively
Last Modified On: 03/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to know the effect of Mashasaptaka decoction and Mashasaptaka taila nose drops in stroke (cva) 
Scientific Title of Study   Clinical study on the combined effectiveness of Mashasaptaka kwatha and Marsha nasya with Mashasaptaka taila in Pakshaghata(Cerebrovascular accident-infarct) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Gusain 
Designation  PG scholar Department of Kayachikitsa 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  OPD No 04, Kayachikitsa OPD,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9972145672  
Fax    
Email  ng5.12.94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Muttappa Totad 
Designation  Associate Professor Department of Kayachikitsa 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Kayachikitsa OPD No 4,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886924949  
Fax    
Email  totadmv225@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Muttappa Totad 
Designation  Associate Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886924949  
Fax    
Email  totadmv225@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India College Phone:08172256460 Email:sdmcah@gmail.com 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  BM Road Thanniruhalla Hassan 573201 Karnataka India  
Type of Sponsor  Private medical college 
 
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 
Dr Nidhi Gusain  OPD NO- 04, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan   BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA 		 9972145672

ng5.12.94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India  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: PAKSHAGHATAH/PAKSHAVADHAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mashasaptaka kwatha and Mashasaptaka taila  Mashasaptaka kwatha 30 ml thrice daily with hingu-125mg and saindhava-1 gram as anupana for 7 days. Marsha nasya with Mashasaptaka taila 8 drops in each nostril twice daily for 7 days. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Subjects who are conscious and oriented
2.Subjects fit for nasya
3.Subjects of either gender
4.Subjects aged between 30-80 years
5.Subjects who are ready to participate and sign the informed consent form 
 
ExclusionCriteria 
Details  1.Subjects with uncontrolled diabetes mellitus and uncontrolled hypertension
2.Diagnosed cases of intracranial haemorrhage , intracranial space occupying lesion,
Congenital defects and carcinoma, Intra cranial infections.
3.Pregnant women and lactating mother  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Signs and symptoms of Pakshaghata like Cheshta Nivritti,Vaakstambha,Ruja will be assessed before and after treatment on the 8th day.  Signs and symptoms of Pakshaghata like Cheshta Nivritti, Vaakstambha, Ruja will be assessed before and after treatment on the 8th day. 
 
Secondary Outcome  
Outcome  TimePoints 
National Institute of health stroke scale;Medical research council scale for muscle strength  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 2 
Date of First Enrollment (India)   10/01/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is an open label,single arm,exploratory,prospective clinical study to know the effectiveness of Mashasaptaka kwatha-30ml thrice daily after food and Marsha nasya with Mashasaptaka taila 8 drops in each nostril twice daily in 30 patients of pakshaghata(Cerebrovascular accident-infarct) that will be conducted in India. The outcome measures are the signs and symptoms of Pakshaghata,NIHSS and MRC scale for muscle power. 
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