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CTRI Number  CTRI/2020/08/027494 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 30/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To identify the pathogenesis of COVID-19 at different stages with the help of Ayurveda 
Scientific Title of Study   Identifying the pathological models of COVID-19 in Ayurveda: Shat kriyakala & Vikara Vighata bhava abhava -A cross sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanuja Nesari 
Designation  Professor  
Affiliation  All india Institute of Ayurveda  
Address  Director office Ground floor C block All India Institute of Ayurveda Gautampuri Sarita vihar New Delhi

South
DELHI
110076
India 
Phone  9958817145  
Fax    
Email  asthmatamv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tanuja Nesari 
Designation  Professor  
Affiliation  All india Institute of Ayurveda  
Address  Director office Ground floor C block All India Institute of Ayurveda Gautampuri Sarita vihar New Delhi


DELHI
110076
India 
Phone  9958817145  
Fax    
Email  asthmatamv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tanuja Nesari 
Designation  Professor  
Affiliation  All india Institute of Ayurveda  
Address  Director office Ground floor C block All India Institute of Ayurveda Gautampuri Sarita vihar New Delhi


DELHI
110076
India 
Phone  9958817145  
Fax    
Email  asthmatamv@gmail.com  
 
Source of Monetary or Material Support  
COVID HEALTH CENTRE AND COVID TESTING LABORATORY OF All INDIA INSTITUTE OF AYURVEDA 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri Sarita vihar New Delhi 110076  
Type of Sponsor  Government 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 Sisir Kumar Mandal  All INDIA INSTITUTE OF AYURVEDA  GOTAMPURI SARITA VIHAR NEW DELHI 110076
South
DELHI 
8697097984

todrskmandal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B342||Coronavirus infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients >20 yrs.
SARS COV-2 confirmed by RT PCR/RAD
Mild to moderate category
patients with potential risk factor
Patient willing to participate 
 
ExclusionCriteria 
Details  Patient unwilling to take part
Unconscious patient 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To validate concept of shatkriyakala and vikara vighat bhava abhava in pathogenesis of covid-19  2 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
To validate concept of shatkriyakala and vikara vighat bhava abhava in pathogenesis of covid-19  4 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   06/09/2020 
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   A book will be published after completion of study 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Global community is facing an unprecedented pandemic of novel coronavirus disease (COVID-19) caused by Severe Acute Respiratory Syndrome -  Coronavirus 2 (SARS-CoV- 2). The pandemic is continuing to spread and the need of  a clinically-proven prophylaxis and therapeutic strategy is evident .  The dimensions of pandemic require an urgent harnessing of all knowledge systems available globally.

Ayurveda has enough potential and possibilities to be employed both for prevention and treatment of COVID-19. Therefore , there is an urgent need to understand the pathophysiology of the morbidity so that an effective management can be planned accordingly .  Another substantial question is “ why some patients with the virus do very well whereas others need to be admitted to intensive care and may die from the disease.”[1]

Why does the response to the same etiological factor  ;  vary from individual to individual?

Along with that severity of disease is closely related to the prognosis, the basic and essential strategies to improve outcomes that we should adhere to remain the early detection of high-risk and critically ill patients. Probing into such questions can redefine the pathogenesis of the morbidity through a new dimension .

 

1.2 Relevance of the work

 

This observational  study is an attempt to trace the pathological models of COVID 19 framed on the principles of Ayurveda.   The frameworks play an instrumental  role in the progression and manifestation of the disease. In this particular study , the researchers will be focussing on two basic models which are as follows :

1)    Shat - kriya kala

2)    Vikar vighata - bhava ; abhava ( Nidana , dosha , dushya paradigm )

 

1) Pathological model 1 - Shat kriya kala

The term Kriyakala refers to the recognition of the stage of a disease  progress, which helps to determine appropriate measures to correct the imbalance in Doshas . It is defined as a  compound expression, composed of Kriya and Kala, where Kriya means the intervention of choice and kala refers to the stage of progress of a disease. [2]

 

2) Pathological model 2 -  Vikar vighata - bhava ; abhava ( Nidana , dosha , dushya paradigm )

“Diagnosis” in Ayurveda is in terms of the nature or the phenomenon of the disease. This phenomenon is described in terms of the Samprapti (pathogenesis) of the disease in each patient, comprising Dosha, Dushya and Adhisthana components .[3] The specific interaction of etiological factors with doshas and dushyas, as well as the presence or absence of disease-resisting factors (individual’s immunity or ability to resist the disease), influence the outcome regarding the manifestation of a disease  It is stated that if the interaction of etiological factors, doshas and dushyas are weak and these are antagonistic to each other, and if the influence of temporal factors (time or seasonal influence) are also weak, then either the disease does not manifest, or there is a delay in manifestation of the disease.[4]  In such cases, even if there is an onset of the disease, its severity could be low, or all of its signs and symptoms may not manifest. Thus, the presence or absence of specific factors determine the ability or otherwise of the body to resist all types of diseases.

Recent studies have reported that the severity of the disease is a function of individual immune response to the virus.The response is a function of 3 factors - Hetu ; Dosha ; Dushya .[5]  The permutation and combination of the three variables in a particular body type can give a direction to the manifestation and progression of the disease.

 

 

 

 

 

 
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