Name of
title:
To
Determine the Efficacy of An Ayurvedic Preparation, Raj Nirwan Bati (RNB) on
Symptomatic COVID-19 Patients: A Double-Blind Randomized Controlled Trial
Aim and
Objectives:
1. To determine the efficacy of an ayurvedic
preparation Raj Nirwan Bati (RNB) in treatment of symptomatic COVID-19
Patients.
2. To find out the duration of conversion of
symptomatic patients to asymptomatic
3. To find out the duration for becoming RT-PCR
negative
4. To evaluate the therapeutic response of
RNB on bio-chemical and haematological profile.
Material
and Methods:
Study
design: A
double-blind randomized controlled trial
Study
units: Symptomatic
patients diagnosed to be infected with SARS-CoV-2 and suffering from COVID-19
illness.
Place
of study: Patients
admitted in the indoor department of COVID-19 hospital at Uttar Pradesh
University of Medical Sciences, Saifai, Etawah, Uttar Pradesh.
Study
Duration: June
2020 onwards till the outcome variables in the study patients are met.
Sample
Size: 30
cases in Intervention group and 30 in Control group
Study
intervention tool: An
ayurvedic preparation by the name of Raj Nirwan Bati (RNB).
Inclusion
criteria:
1. RT-PCR confirmed SARS-CoV-2 infected symptomatic patients
admitted to the COVID-19 hospital of UPUMS
2. Patients falling in mild, moderate and severe category of
COVID-19 illness
3. Patients more than 18 years of age
Exclusion
Criteria:
1. All critically ill patients of COVID-19
2. Patients not providing informed written consent for
the study
3. Pregnant and lactating females
4. Patients of Chronic kidney disease (CKD) more than stage
three
5. Asymptomatic cases
6. Study participants becoming critically ill during
the course of intervention.
Methodology:
As an
initial step, all suspected or laboratory confirmed patients coming to COVID-19
hospital of UPUMS, Saifai, Etawah shall be screened both clinically and by
repeat laboratory tests to confirm the SARS-CoV-2 infection status and make the
diagnosis of COVID-19. Those patients providing the consent and fall in mild,
moderate and severe category of COVID-19 illness shall comprise our study units
or subjects. Patients with fever, dry cough, myalgia and other non-specific
symptoms will be categorized as “mild illness” while “moderate illness” will
have above symptoms along with dyspnoea on exertion or tachypnoea (Respiratory
rate > 18/minute and oxygen saturation > 94%. The “severe illness”
category of patients will be having any of the above sign and symptom with
oxygen saturation between 90-94%.
After the
initial screening, random allocation of these patients will be done in the
intervention group and control group. Both groups or arms of the RCT will
comprise of a sample of 30 patients in each study group. A battery of
bio-chemical, haematological, micro-biological, radiological and other specific
tests required for the management of co-morbid disease shall be performed on
the selected study patients. The intervention group of patients will receive
the Raj Nirwan Bati (RNB) in dose of 125 mg (1 Ratti) tablet twice a day with 5
to 10 ml honey/desi ghee empty stomach for duration of 12 days. On the other
hand, the control group of patients will be administered placebo in the form of
calcium tablet.
All the patients
of both intervention and control group will receive the allopathic treatment as
per standard protocols of the university. Regular vitals monitoring will be
done of all the patients. Their repeat naso-pharyngeal swab will be taken for
SARS-CoV-2 infection by RT-PCR examination on day 6 and 12 of RNB therapy.
Routine investigations like complete blood count, Liver function tests, Renal
function tests, LDH, CPK, CRP, Chest X-ray PA view, Ultrasonographic
examination will be done at the time of admission and will be repeated on day 6
and day 12 of the illness.
The
outcome variable of the study will be in the form of status of patients
1. RT-PCR
report negative at day 6 of intervention
2.
Persistence of symptoms beyond day 5 in mild cases and day 7 in moderate cases
3.
Worsening of clinical features beyond day 5 except severe cases
4. Changes
in bio-chemical parameters like LDH, CRP, SGPT, SGOT
5. Changes
in haematological parameters
6. Radiological
worsening.
Statistical
Analysis:
Data thus
collected shall be entered in Excel spreadsheet and analysed using spss
statistical software (version 21) using appropriate tests. |
