1. Title of the Research
Project: "Randomized Clinical Trial of Ayurveda Spice
Mix Tabetfor the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare
Personnel/Covid Fighters/High-Risk patients”
2. Objectives:
Primary: Reducing the number of patients in Health workers/health
professionals, Covid fighters like Police social worker and high risk patients
in public/private hospitals in India or in areas of risk of SARS-CoV-2 transmission and PEOPLE EXPOSED to COVID 19 Or having CONTACT history
Secondary: Reduction in duration of symptoms measured in days and severity
of Symptoms of SARS-CoV-2 (COVID-19) confirmed infected participants of
SARS-CoV-2 (COVID-19in Covid Fighters/health care personnel and clinical
severity COVID-19 among hospitals aged 18 to 75 years in public/private
hospitals in India or in areas of risk of SARS-CoV-2 transmission and PEOPLE EXPOSED to COVID 19 or Having CONTACT history
3. Methodology
Inclusion Criteria-
1.
Male or female aged 18-75 years
2.
Health care workers/Covid Fighters like police/Social workers etc or high
risk group patients in public/private hospitals in India or People in areas of
risk of SARS-CoV-2 transmission.
3.
People exposed to Covid 19 or having Contact history in 14 days
4.
Understanding of the aim of the study and, therefore,acknowledging they
have not been on any drug aiming atpre exposure prophylaxis against SARS-CoV-2
(COVID-19) since 1st of May 2020 untill 7 days before the study. This also
includes drug forHIV.
5.
Negative pregnancy test during the previous 7 days to start treatments or
more than 2 years after menopause.
Exclusion Criteria -
1.
COVID + Ve Patient with Symptoms of severe pneumonia/Hospitalised
2.
Active hepatitis B infection, HIV infection
3.
Renal failure with estimated glomerular filtration rate(GFR) < 60
ml/min) and patients on Hemodialysis.
4.
Participant with any immunosuppressive condition orhematological disease
5.
Breastfeeding
6. Known allergy to any of the
medication used in this trial
STUDY ARMS - Two
1.
Experimental – Ayurveda spice mix therapy(Tulsi
immune) with conventional treatment if taken already
2.
Standard control – Conventional Treatment HCQS+ Antiviral/azithromycin
STUDY DESIGN – Randomised controllede clinical trial
Randomisation – 1:1 After screening for inclusion
Allocation – computer
generated numbers Concealment of allocation – central randomization
Sampling method – simple
sampling method
Sample size 130 patients
Study sites – Ashtang Ayurved Mahavidyalaya- Rugnalaya,
Pune Postal address: 2062,
Sadashiv Peth, Late Vd. H. B. Paranjpe
Chouk, Vijayanagar Colony, Pune 411030
4. Intervention and detailed posology
THE STUDY INTERVENTION
PROCEDURE, The Aryurvedic therapy will be
start at D0 to all SARS Cov2 health personnel /covid Fighter like police social
workers/high risk patients who will continue their conventional treatment in
experimental arm.
Conventional treatment
patients taking is a standard control for this study.
· Experimental - Ayurveda spice
mix Tablet (Tulsimmune) with life style advise like Gargling, Nasal/chest oil
Application and liquid dominant diet Intervention
1.Internal Intervention – Ayurveda Spice
mix (Tulsimmune) tablet 500 mg three times a day with preferably chewing or with
hot water/water
2.A special lifestyle regimen
diet plan the person will follow which will include two substantial meals and
one liquid meal, tea with spice like ginger, nasal chest application of
Coconut oil with camphor in it.
Each Participant will receive
Ayurveda spice mix tablet (Tulsimmune) for 28 days
· Standard Control – Conventional treatment-like HCQS
+antival/azithromycin
5. Assessment criteria
Primary Outcome measures
1.Reducing number of infected patients in health professionals
/workers, Covid fighters like police, social workers etc.
Secondary Outcome Measures
1. Reduction in duration of symptoms measured in days and severity of
Symptoms of SARS-CoV-2 (COVID-19) confirmed infected participants of SARS-CoV-2
(COVID-19
2. Reduction in clinical severity of SARS CoV2 by SpO2,
Temp. Bp, Lab testing and Pulmonary Imaging If
6. Anticipated Outcome
Invention of
Preventive prophylactic treatment for SARS Cov2 infection
7. Summary of the proposed research (up to 150 words ) indicating
overall aims of the research, importance of the objectives and their
application in the context of the priority areas set out in the application
form.
Healthcare
professionals/workers and covid fighters like police, social workers are
particularly at risk of SARS-CoV-2. In the absence of a vaccine, other
strategies aiming to reduce the development of COVID-19 in the population, more
specificallyin healthcare workers is being sought. Administration ofeffective
drugs to people at risk of developing an infectiousdisease is well accepted and
is part of clinical practice. To date
there are some on-going
randomized clinical trial on Preexposureprophylaxis evaluating chloroquine /hydroxychloroquine
amd Antiviral drugs like Remdesivir efficacy for health care workers and
othergroups of patients at high risk. Ayurveda, an ancient system of health
and medicine described the epidemic or pandemic situation occurs due to
contaminated air, water, seasons etc2 as well as touch of plant, human, animal
etc. asa result ofthat human can suffer from fever, respiratory distress and
degenerations Ayurveda says. This study aims to assess the efficacy of a daily Three
dose ofAyurvedic spice mix tablet (Tulsimmune) with conventional treatment like
HCQS antiviral/azithromycin as prophylaxis during 28 days: (1)reducing the
incidence of symptomatic disease and (2)reducing clinical severity COVID-19
among healthcareworkers/professionals Covid fighters aged 18 to 65 years in
public/private hospitals inIndia and High risk area of transmission. The spice
Mixcontents are described in study design/appendix. The ingredients arehaving
antiviral, immunomodulatory effects. Also they are supportingrespiratory
system, reducing inflammation
8. Relevance and usefulness of the study with particular reference
to concerned AYUSH system.
As there is no proven
prophylactic preventative measures and Ayush system is known for preventative
measures, this study will establish the role of Ayush system in prevention of
novel diseases emerging in 20th century. It will establish the importance of
usefulness of simple spices in food and Deencharya regimen in new diseases. It
will also underlines the importance of Ancient knowledge system in todays
perspective. |