Role of immune boosting kit in covid disease

Not yet recruiting

Conditions: healthy

Registration Number: CTRI/2020/07/026670

Lead Sponsor: All India Institute of Ayurveda

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 identifiedin 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 â€œcytokine stormâ€ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

susceptible general population having risk of exposure to COVID-19 infection from different regions of Delhi.

Exclusion Criteria

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the efficacy of efficacy of ayurveda interventions in the prevention of COVID -19 infections in susceptible general population	2 months

Secondary Outcome Measures

Name	Time	Method
To observe the quality of life through SF36 questionnaire	5 months

Trial Locations

Locations (1): All india institute of ayurveda
🇮🇳
South, DELHI, India
All india institute of ayurveda
🇮🇳South, DELHI, India
Dr SISIR KUMAR MANDAL
Principal investigator
8697097984
todrskmandal@gmail.com