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CTRI Number  CTRI/2020/07/026670 [Registered on: 18/07/2020] Trial Registered Prospectively
Last Modified On: 18/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role of immune boosting kit in covid disease 
Scientific Title of Study   Evaluation of prophylactic effect of Ayurvedic interventions in the prevention of COVID-19 infections in susceptible general population: A single arm clinical exploratory 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 SISIR KUMAR MANDAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA 
Address  303,THIRD FLOOR ROG NIDAN DEPARTMENT ,All INDIA INSTITUTE OF AYURVEDA

South
DELHI
110076
India 
Phone  8697097984  
Fax    
Email  todrskmandal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SISIR KUMAR MANDAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA 
Address  303,THIRD FLOOR ROG NIDAN DEPARTMENT ,ALL INDIA INSTITUTE OF AYURVEDA

South
DELHI
110076
India 
Phone  8697097984  
Fax    
Email  todrskmandal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SISIR KUMAR MANDAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA 
Address  303,THIRD FLOOR ,ROG NIDAN DEPARTMENT,ALL INDIA INSTITUTE OF AYURVEDA,NEW DELHI-110076

South
DELHI
110076
India 
Phone  8697097984  
Fax    
Email  todrskmandal@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda,Gautampuri,Sarita vihar,new delhi-110076 
 
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   Gautampuri 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 
Healthy Human Volunteers  healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  chyawanprash avaleha , sanshamani vati,anu tail,ayush kwath  chyawanprash-15gm once in morning with lukewarm milk empty stomach sanshamni vati-500mg twice a day 1/2 hour before meal Anu tail nasya -2 drops per nostrils twice a day Ayush kwath -40ml twice a day after meal  
Comparator Agent  NOT applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Year(s)
Gender  Both 
Details  susceptible general population having risk of exposure to COVID-19 infection from different regions of Delhi  
 
ExclusionCriteria 
Details  all those who are not willing to participate in the study
age less than 18 years and more than 60 years
co-morbid condition (diabetes) 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of efficacy of ayurveda interventions in the prevention of COVID -19 infections in susceptible general population   2 months  
 
Secondary Outcome  
Outcome  TimePoints 
To observe the quality of life through SF36 questionnaire   5 months 
 
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)   28/07/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

COVID-19 has emerged as a global threat to the entire humanity. Corona virus was discovered much earlier affecting animals and birds. It managed to enter the human causing outbreaks in 2002-2003 as SARS, followed by 2014. Recently, in December 2019 Wuhan city in China experienced low respiratory infections [1,2] with causative agent identified in Jan 2020 as novel corona virus, officially called severe acute respiratory coronavirus 2 (SARS-CoV-2), from throat swab sample of the patients. By February 2020 WHO reported it as COVID-19 (corona virus disease 2019) [3.4,5] seventh member of enveloped corona virus [6].  Now it has become a major challenging problem of health care not only by China but also for other countries in all over the world. WHO declared this outbreak as public health emergency of international concern (PHEIC) [7].

According to data updated on 7th June 2020, globally 6,997,348 cases of COVID-19 have been reported with 402,495 deaths.( https://www.worldometers.info/coronavirus/) According to Ministry of Health and Family Welfare [8], Number of cases of COVID-19 in India has been reported as 120406 with 6929 deaths.

Transmission of COVID-19 is by human to human contact through droplet infection, aerosols, fomites of cough, sneeze; direct contact of mucosa with body fluids. The aerosols are reported to be viable in air and on various surfaces up to 72 hours.

The incubation period has been reported from 1 to 14 days, with median of 5 to 6 days and also reported to be 24 days [9]. This incubation period is very important in deciding about the isolation strategies of the exposed asymptomatic population. The immune status of the individual is a very important factor determining the clinical outcome of the infection.

The exact pathogenesis of COVID-19 is though unclear but disruption of alveolo-capillary components with resultant pulmonary edema, exaggerated immune response with “cytokine storm” has been envisaged along with leukopenia as the predominant mechanisms behind the manifestation of multi organ failure. The clinical picture varies with mild to severe form of respiratory symptoms like sore throat, cough, dyspnoea with fever. Other symptoms include muscle ache, headache, confusion, chest pain, diarrhoea, dizziness and abdominal pain. Gastrointestinal presentations are though rare, but when present signify lesser rate of cure. This could be due to the delay in their diagnosis and treatment or may be related to gut-lung axis, suggesting more severe respiratory response by that intestinal infection due to activation of ACE2 in the liver, creating micro biome dysbiosis and thus promoting a more vigorous systemic inflammatory response [10].

Emergency treatment are being done according to severity. No single type of treatment protocol can be applied. Several treatment modalities reported include -Overall oxygen therapy along with antibiotic treatment including cephalosporins, quinolones, carbapenems, tigecycline, linezolid [11]. Hence, it is important to take preventive measure and all necessary precautions in order to prevent the disease including the use of surgical masks, washing hands or rinsing hands with alcohol-based sanitizers and maintaining social distancing to slow down the spread. Till now, there is no vaccine or specific treatment, however, various clinical trials for the reduction in the clinical progression of COVID-19 and vaccine production are underway in various countries in Phase I and II [12].

In addition, Immunocompromised old age population as well as critical or key workers for emergency services like medical/paramedical staff, police staff and cleaning staff who may come directly in contact with COVID-19 infected persons are at higher risk due to non-availability of any vaccine for COVID-19.

Ayurveda, traditional Indian medicine of plant drugs has been successful from very early times in using these natural drugs and preventing or suppressing various viral diseases using various lines of treatment. Integrating with traditional medicine like Ayurveda can provide a "bed to bench" and "bench to bed" back approach towards the prevention of such pandemic of COVID-19 as they may protect against such infection or reduce the duration or severity of this infection.

 
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