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Evaluation of an Ayurvedic formulation in clinical recovery of COVID-19 patients: A placebo controlled pilot study among moderate-severe patients

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Introduction: The COVID-19 pandemic is a global health crisis that has affected millions of people worldwide. Apart from measures taken to reduce the transmission of virus and provide symptomatic relief to patients, a potent drug targeted against the virus is required to manage the disease. Traditional medicines with an array of phytochemicals and potent anti-viral properties, can provide alternate solution in the therapeutic cure of COVID-19. Objective: The present study investigates the efficacy of an Ayurvedic formulation, NOQ19, on the rate of recovery and clinical improvement among moderate-severe COVID-19 infected patients who were not on a ventilator or in intensive care unit. Methods: A placebo controlled randomized study design, with 1:1 ratio between the intervention and placebo arms was adopted. The participants were provided their respective intervention along with the standard of care treatment. A follow up was conducted on Day 7 and Day 10 to assess the rate of recovery and clinical improvement. Rate of recovery was the primary outcome measured and was determined by a negative result on the RT-PCR test. The secondary outcomes included clinical improvement among patients and were measured using blood biomarkers. Results: The NOQ19 arm had a higher percentage of population who turned RT-PCR negative on Day 7 (23%) when compared to the placebo arm (11%). Further subgroup analysis demonstrated that for both moderate and severe patients, there were a greater percentage of population who were RT-PCR negative in the NOQ19 arm compared to the placebo arm at Day 7: (NOQ-19: 22.22%, Placebo: 14.29% for moderate patients), (NOQ19: 23.08% Placebo: 0% for severe patients). By Day 10, both populations depicted an almost similar percentage of the population who were RT- PCR negative. Both the groups demonstrated an improvement in blood biomarkers, although the improvement was greater in the NOQ19 arm. None of the patients in the intervention arm reported any adverse events. Conclusion: The results of this pilot RCT indicates that NOQ19 along with standard of care treatment can be considered as an effective therapy for COVID-19 and aid early recovery from the disease.
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Evaluation of an Ayurvedic formulation in clinical
recovery of COVID-19 patients: A placebo controlled
pilot study among moderate-severe patients
Abhishek Arun
Atharva Multi speciality Hospital & Research Centre
Amit Gupta
Centre for Diabetes care, Noida
Saumya Subramanian
SRI SRI INSTITUTE FOR ADVANCED RESEARCH
Divya Kanchibhotla ( divya.kanchibhotla@artoiving.org )
SRI SRI INSTITUTE FOR ADVANCED RESEARCH
Research Article
Keywords: Ayurveda, COVID-19, early recovery, NOQ19, Moderate
Posted Date: December 27th, 2021
DOI: https://doi.org/10.21203/rs.3.rs-1169591/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License.  Read
Full License
Page 2/16
Abstract
Introduction: The COVID-19 pandemic is a global health crisis that has affected millions of people worldwide.
Apart from measures taken to reduce the transmission of virus and provide symptomatic relief to patients, a
potent drug targeted against the virus is required to manage the disease. Traditional medicines with an array
of phytochemicals and potent anti-viral properties, can provide alternate solution in the therapeutic cure of
COVID-19.
Objective: The present study investigates the ecacy of an Ayurvedic formulation, NOQ19, on the rate of
recovery and clinical improvement among moderate-severe COVID-19 infected patients who were not on a
ventilator or in intensive care unit.
Methods: A placebo controlled randomized study design, with 1:1 ratio between the intervention and placebo
arms was adopted. The participants were provided their respective intervention along with the standard of
care treatment. A follow up was conducted on Day 7 and Day 10 to assess the rate of recovery and clinical
improvement. Rate of recovery was the primary outcome measured and was determined by a negative result
on the RT-PCR test. The secondary outcomes included clinical improvement among patients and were
measured using blood biomarkers.
Results: The NOQ19 arm had a higher percentage of population who turned RT-PCR negative on Day 7 (23%)
when compared to the placebo arm (11%). Further subgroup analysis demonstrated that for both moderate
and severe patients, there were a greater percentage of population who were RT-PCR negative in the NOQ19
arm compared to the placebo arm at Day 7: (NOQ-19: 22.22%, Placebo: 14.29% for moderate patients),
(NOQ19: 23.08% Placebo: 0% for severe patients). By Day 10, both populations depicted an almost similar
percentage of the population who were RT- PCR negative. Both the groups demonstrated an improvement in
blood biomarkers, although the improvement was greater in the NOQ19 arm. None of the patients in the
intervention arm reported any adverse events.
Conclusion: The results of this pilot RCT indicates that NOQ19 along with standard of care treatment can be
considered as an effective therapy for COVID-19 and aid early recovery from the disease.
1.0 Introduction
Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. The rapidly growing
outbreak of COVID-19 and resulting public health crisis has garnered worldwide attention1, affecting 200
nations across the world2. COVID-19 was declared a pandemic by the World Health Organization (WHO) on
March 11, 20203. Supportive therapy such as ventilation to optimize oxygen saturation and uid management
to intercept respiratory failure are the mainstay of current COVID-19 management4. Currently, there is a need
for an antiviral drug with a targeted approach towards the virus that can reduce the viral load or cease viral
replication5.
Ayurveda, an Indian traditional system of medicine, recommends several potent herbs and associated
formulations for the prophylactic and therapeutic management of COVID-196. Our study focuses on an
Ayurvedic polyherbal formulation containing well-known popular Ayurvedic drugs such as Ashwagandha
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(
Withania somnifera
), Yashtimadhu (
Glycyrrhiza glabra
), Pippali (
Piper longum
), and Guduci (
Tinospora
cordifolia
). Several of these drugs have been recognized for their antiviral potency7-12. Phytochemical
analysis of multiple Ayurvedic herbs used for their antimicrobial properties, demonstrates the presence of
phenols, alkaloids and avonoids, which contribute towards their antimicrobial activity13. A review of
literature on individual components and their phytoconstituents highlights the importance of blending selected
herbs into a formulation14.
In silico
studies on Ashwagandha (
Withania somnifera
) have demonstrated its
antiviral properties against SARS-CoV-215-16. Among its chief phytochemical components are Withnolides,
which play an active role in inhibiting viral entry into the host cells. Potential targets of Withnolides include
TMPRSS2 and Mpro receptor protein and viral proteins. These proteins play an important role in viral entry
and viral replication inside the host cell17. Another molecular docking study of Ashwagandha (
Withania
somnifera
), Guduchi (
Tinospora cordifolia
) and Shatavari (
Asparagus racemosus
) demonstrated that the
combined effect of phytochemicals from the three herbs target against the spike protein, main protease and
RNA dependent RNA polymerase enzyme of the virus required for replication18. Yashtimadhu (
Glycyrrhiza
glabra
), another potent antiviral drug, has been studied
in silico
for its mechanism of action.
In silico
studies
highlight glycyrrhizin as one of the best antiviral chemicals against SARS-CoV-219. An animal study also
highlights that glycyrrhizin plays an important role in reducing the number of Angiotensin converting enzyme
2 (ACE2) receptors in the lung tissue, which is the main binding site of SARS- CoV-2 in humans20.
Other components of NOQ19 such as Giloy (
Tinospora cordifolia
), Bhumiamla (
Phyllanthus fraternus
),
Vasaka (
Adhatoda vasica
), Bhunimba (
Andrographis paniculata
) and Haridra (
Curcuma longa
) contain
phytochemicals that target the Mpro protein of the virus. Amritoside and Apigenin-6- C-glucosyl7-O-glucoside
from Giloy (
Tinospora cordifolia
), and Pectolinarin and Astragalin from Bhumiamla (
Phyllanthus fraternus
)
are among the few compounds that have demonstrated the highest docking ability with Mpro protein21.
Vasaka (
Adhatoda vasica
) is a well-known anti- inammatory, antiviral and antitussive herbal drug.22 Known
for its antithrombotic properties, Bhunimba (
Andrographis paniculata
) prevents blood clotting. Blood clotting
is one of the severe clinical presentation of SARS-CoV-2 virus23 and antithrombotic properties of Bhunimba
(
Andrographis paniculata
) can reduce blood clotting. A common spice used in Indian cooking with excellent
antiviral properties is Tumeric or Haridra (
Curcuma longa
)24. Curcumin, the chief component of Haridra is a
phenolic compound which has an inhibitory effect against Toll-like receptors, inammatory cytokines and
chemokines.25-26. This is crucial in COVID-19 since it can regulate the cytokine levels and inhibit the cytokine
storm.
A previous
in vitro
analysis of NOQ19 formulation demonstrated a 100% antiviral ecacy at 0.9mg/ml
against SARS-CoV-2 virus in a Vero E6 cell based assay27. Further evaluation of NOQ19 in an
in vivo
model
using Syrian golden hamsters demonstrated a 78.2% ecacy and no toxicity in animals. The gross lung
pathology and body weight reduction improved signicantly in the NOQ19 group of hamsters28. The present
study aims to determine the clinical ecacy of the above mentioned Ayurvedic herbs in a formulation, namely
NOQ19, in recovery from COVID-19. Based on the previous literature,
in vitro
and
in vivo
studies on NOQ19, we
hypothesize a strong therapeutic activity of this polyherbal formulation in COVID-19 patients.
2.0 Methods
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2.1. Trial design
The present study was a pilot, single centre, double blind, randomized control trial. The study was approved by
the Institutional ethics committee of Atharva multi-speciality hospital and research, with the registration
number IEC/04/17/21/01. The study protocol was in compliance with the Helsinki Declaration and Good
Clinical Practice. Adults presenting with moderate to severe COVID-19 infection, without requiring ventilation,
at the OPD or IPD were screened for eligibility and invited to participate in the study. Informed consent was
obtained from patients willing to
participate in the trial. The study was conducted from 19th April to 28th May, 2021. Each patient was
monitored for 14 days from the time of enrollment. The study has been registered at Clinical Trial Registry
India after the completion of this pilot study with registration number CTRI/2021/10/037423
2.2 Participants
A total of 40 patients who presented to the OPD/IPD in Atharva Multi-speciality hospitals were recruited for the
study. A total of 22 patients were enrolled in the NOQ19 arm while 18 in the Placebo arm. All enrolled patients
presented with symptoms of COVID-19 and tested positive on RT-PCR. The eligible participants (based on the
eligibility criteria listed below) were informed about the research study. Medical history of the patients was
documented and baseline parameters were assessed.
2.2.1. Inclusion Criteria
a) Age 21 to 75 years
b) Symptomatic COVID-19 infected patients with or without comorbidities
c) Reported to OPD within three days of onset of symptoms
d) Willing to take AYUSH treatment
2.2.2. Exclusion Criteria
a) Not willing to give consent/ participate in the clinical trial
b) Age less than 20 years or more than 75 years
c) Patients with chronic comorbidities like diabetes, chronic heart conditions and HIV/AIDS
d) Pregnant and lactating mothers
e) Patients on immunosuppressive therapy
f) SARS-CoV-2 infected patients on ventilation or in ICU
2.3 Intervention:
Patients enrolled in the study were provided respective intervention along with the standard of care treatment.
The patients received a bottle containing 90 tablets each, as per their intervention. They were advised to take
two tablets (500mg each) TID (thrice a day), under supervision (if IPD), along with the standard of care
treatment. Compliance was monitored by the study team daily for each patient individually, in person for the
patients admitted in the hospital while out patients were monitored telephonically.
2.3.1 : NOQ19 preparation
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NOQ19 is a polyherbal formulation containing 19 ingredients made with 13 herbs. They are Ashwagandha
(
Withania somnifera
) powder and extract, Bilwa (
Aegle marmelos
), Yashtimadhu (
Glycyrrhiza glabra
) powder
and extract, Rasna (
Pluchea lanceolata
), Vasaka (
Adhatoda vasica
) powder and extract, Pippali (
Piper
longum
), Haridra (
Curcuma longa
), Patha (
Cissampelos pareira
), Bhumiamla (
Phyllanthus fraternus
) powder
and extract, Bhunimba (
Andrographis paniculata
) powder and extract, Saptaparna (
Alstonia scholaris
), Tulasi
(
Ocimum sanctum
) and Guduci (
Tinospora cordifolia
) powder and extract.
NOQ 19 was procured from Sriveda Sattva Pvt Ltd, Bangalore (Sri Sri Tattva). NOQ19 was licensed by the
Ministry of AYUSH, Govt. of India : license number- AUS782. All the herbs & herbal extracts which constituted
NOQ19 were subjected to quality control. All the ingredients were blended with excipients followed by
granulation, drying and compression. After passing the QC test, the tablets were packed in bottles following
standard procedure.
2.3.2 Comparator group
The placebo control group was provided with the placebo tablets (made of only starch), which were packed in
bottles identical to the NOQ19 bottle.
2.3.3 Standard Treatment of Care
Standard of care treatment included allopathic medicines as prescribed by the Government of India29.
Moderate patients admitted in the hospital were given Inj. Doxycycline, Inj. Azithromycin, Antipyretics and
Supportive care i.e Fluids, Intravenous Steroids like Dexamethasone, Supportive oxygen therapy, Nebulization,
Vitamin C and Zinc. Patients who were clinically stable were treated on OPD basis and did not require
hospitalization. They were given Tab Doxycycline 100mg BD for 5 Days, Azithromycin (500mg)- one tablet,
OD, for 5 days, Vitamin C one tab TID, Tab Ivermectin 12mg OD for 3 days, Zinc, one tablet, OD and
Paracetamol (500 mg) when required.
2.4. Outcomes
After enrollment, the patients were monitored for 14 days. All patients were followed up for RT- PCR test on
Day 0, Day 7, Day 10 to monitor viral load changes. One nasal and one throat swab were obtained for RT-PCR
analysis.
2.4.1 Primary Outcome:
The primary outcome was the rate of recovery from COVID-19 based on RT-PCR negative test results.
2.4.2 Secondary Outcomes :
Secondary outcomes included clinical improvement among the patients as evaluated by blood biomarkers
and chest CT score. Inammation markers (CRP), antithrombotic activity (D-Dimer), cytokine levels (IL-6), HR-
CT chest score and S-Ferritin were measured. The blood parameters and immune markers were measured on
Day 0 and Day 10 to observe any signicant changes.
2.5. Sample size calculation
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Being a pilot study, as a rule of thumb, the sample size was restricted to 50 in number30. However, due to the
decrease in the number of patients in the IPD/OPD ward, the study was discontinued at 40 patients.
2.6. Randomization and blinding
The participants were randomized into respective study groups. A computer-generated sequence of
randomization was adopted for the study. Based on their inow, the patients were allocated numbers
sequentially and thereafter randomized into groups. All the subjects were randomized in a 1:1 ratio between
the intervention and placebo arm. The appropriate intervention was administered by the duty doctor who was
not involved in the study. The data collector, operator and lab technicians were blinded to the intervention
along with the subjects.
2.7. Statistical analysis
The baseline characteristics of both study groups were reported as proportion/ mean (SD). Data analysis was
conducted using the intention to treat (ITT) approach. Data was compiled and analyzed using Microsoft Excel
2019 (16.0.12026.20334) 32-bit. Data was tested for normality using IBM SPSS statistics software V 2.0. The
blood parameters were evaluated by descriptive statistics. Association between variables of qualitative nature
was tested by Chi-square test. Fisher’s Exact test was used when the value of 20% of cells of expected
frequencies were <5 at the level of
0.05 signicance. Association between variables of quantitative nature was tested by Student's T Test (paired
and unpaired) wherever appropriate.
2.7.1 Subgroup analysis
Based on the Government of India guidelines, the patients were categorized as moderate or moderate-severe
without ventilation based on SpO2 rate. This was further conrmed with Chest CT score, since all the patients
also underwent a chest CT to assess the severity of illness31.
3.0 Results
The study compared the COVID-19 recovery, as measured by RT-PCR and blood biomarkers, between the
intervention NOQ19 arm and placebo arm. Attrition rate in both the study groups was zero.
Table 1 demonstrates the demographic characteristics of the patients enrolled in the study. No signicant
differences in age or gender distribution were observed between the study groups. The two groups were also
similar in height, weight, blood pressure and pulse rate at the time of enrollment. Vaccination status of the
patients was also captured to analyse any change in response of the intervention between the partially and
fully vaccinated groups. A signicant difference was noted in the HR-CT score, SpO2 values, temperature and
respiratory rate between the two groups at the time of enrollment..
According to Berkson’s bias, due to the increased rate of exposure during the study enrollment and likelihood
of patients being admitted in the hospital, the intervention arm had more patients with severe or advanced
symptoms than the placebo arm from the start of the study.32 This resulted in a higher number of patients
being severe in the NOQ19 arm than in the placebo arm. Although patients were classied as severe, none of
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them were in ICU or on ventilation. At baseline, the NOQ19 arm had 41% moderate patients and 59% patients
classied with severe disease, none of whom were on ventilation, while the placebo group consisted of 78%
moderate and 22% patients classied with severe disease.
Table 1
Demographic characteristic of the patients in the study arms
Demography NOQ19 (n=22) Placebo (n=18) p-value
Severity of disease n(%) Mild 0 0
Moderate 9 (41%) 14 (78%)
Severe 13 (60%) 4 (22%)
Age Mean (SD) 53.64 (16.23) 44.44 (16.13)
0.08*
Median 55.5 42
Range 22 – 78 (56) 21 – 75 (54)
Gender n(%) Male 9 (59%) 9 (50%)
0.57
Female 13 (41%) 9 (50%)
Height Mean (SD) 167.2(6.8) 166.9 (7.3)
0.92
Weight Mean (SD) 70.2 (14.2) 73.6 (9.8)
0.39
Pulse Rate (per min.)
Mean (SD)
99 (14.1) 91 (13.8)
0.10
Respiratory Rate
(per min.) Mean (SD)
26 (4.5) 24 (3.9)
0.14
Temperature Mean (SD) 99.6 (1.3) 98.5 (0.9)
0.003*
SpO2
Mean (SD)
90.09 (4.71) 93.89 (4.1)
0.02*
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Blood Pressure Mean (SD) Systolic 134 (16.1) 128 (20.2)
0.29
Diastolic 80 (10.8) 77 (10.7)
0.39
CT- Score n(%) Moderate 9 (41%) 14 (78%)
0.03*
Severe 13 (60%) 4 (22%)
Vaccination (n) Full Vaccination 2 3
<0.001**
Non- Vaccination 14 13
Partial Vaccination 6 2
Smoker (n) 5 4
0.969
Alcohol (n) 4 3
0.9
* p value <0.05 - Signicant
** p value <0.001 - highly signicant
Table 2 demonstrates the inter and intra group analysis of COVID-19 recovery and viral load reduction as
measured by RT-PCR negativity rate at different time points. Among the NOQ19 arm, 23% (n=5) of the patients
were negative on Day 7 while only 11% (n=2) patients were negative in the placebo group. However on Day 10,
the number of patients who were negative in the intervention arm was 37% (n=8), and 50% (n=9) in the
placebo arm. At both the time points the difference was not statistically signicant between the groups.
However, when the patients were grouped by severity of disease (moderate and severe), and analysed
thereafter, a signicant increase in the number of patients turning RT-PCR negative on day 7 was observed
among both moderate and severe patients in the NOQ19 arm. Among the severe patients, the NOQ19 arm
demonstrated an early recovery.
Table 2
Percentage Population with RT-PCR Negative test at Day7 and Day 10
RT-PCR Negative Test NOQ19 (n= 22 )
n (%)
Placebo Arm (n=18)
n (%)
Intergroup p value
Total Population Day 0 0(0%) 0(0%)
Day 7 5 (23%) 2(11%)
0.423
p value
(Day 0 vs. 7)
0.048* 0.48
Day 10 9(41%) 9(50%)
0.523
p value
(Day 0 vs.10)
0.004* 0.0001**
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RT-PCR Negative Test NOQ19 (n= 6)
n (%)
Placebo Arm (n=14)
n (%)
Moderate
Population Day 0 0(0%) 0(0%)
Day 7 2(22%) 2(14%)
0.6588
p value
(Day 0 vs.
7) 0.1690 0.1648
Day 10 6 (67%) 9(64%)
0.9124
p value
(Day 0
vs.10)
0.0039* 0.0003**
RT-PCR Negative Test NOQ19 (n= 13)
n (%)
Placebo Arm (n=4)
n (%)
Severe
Population Day 0 0(0%) 0(0%)
Day 7 3(23%) 0(0%) 0.287
p value
(Day 0 vs.
7) 0.0821 Not applicable
Day 10 3(23%) 0(0%) 0.374
p value
(Day 0
vs.10) 0.0821 Not applicable
* p value <0.05 - Signicant
** p value <0.001 - highly signicant
Table 3 depicts the blood biomarker progression in both the study arms. Signicant differences in
temperature, immune markers and blood parameters were noted between the two groups on the day of
admission. The values for IL-6, a cytokine marker, were signicantly higher in the NOQ19 group as compared
to placebo group at baseline (p=0.02). IL-6 showed a signicant reduction from day 0 to day 10 in both the
arms (intra group p<0.001). However, the mean reduction was greater in the NOQ19 arm (2.2 units) as
compared to placebo (1 unit). Similar trends were observed for S. Ferritin, CRP and D-Dimer. The baseline
values for all the markers were much higher in the NOQ19 arm than the placebo arm. The intragroup p values
were signicant for all markers in both arms, except D-Dimer, signifying that both the arms showed an
improvement. However for all clinical markers, NOQ19 showed a greater improvement as seen by the mean
difference.
Due to the differences in severity of disease between the two arms, the data was further divided into moderate
and severe groups. It was analysed individually for both the arms because the sample size in each sub-group
varied between the arms. Table 4 demonstrates the difference in blood parameters in severe patients among
the NOQ19 and placebo arm. Except D-dimer, all the blood markers signicantly improved by Day 10 in the
Page 10/16
NOQ19 arm. However, a signicant improvement was not noted in the placebo arm, probably because of small
sample size. Therefore, the data was not presented.
Table 3
Blood Parameter Inter and Intra group Analysis at Day 0, Day7 and Day 10
Parameters NOQ19 (n=22) Placebo Arm (n=18) Intergroup p- value
IL-6 Day 0 Mean (SD) 10.3 (6.7) 6.4 (3.0)
0.02*
DAY10
Mean (SD)
8.1 (5.5) 5.4 (2.8)
0.005*
IntraGroup p value <0.001** <0.001**
Mean Difference 2.2 1
S. Ferritin Day 0 Mean (SD) 892.9 ( 471.6) 649.1 (386.5)
0.08
DAY10
Mean (SD)
752.5 (347.2) 563.1 (297.5)
0.071
IntraGroup p value 0.014* 0.001**
Mean Difference 140.4 86
D-dimer Day 0 Mean (SD) 748.1 (394.6) 497.3 (261.9)
0.021*
DAY10
Mean (SD)
641.1 (283.3) 445.8 (225.3)
0.02*
IntraGroup p value 0.113 0.045*
Mean Difference 107 51.5
CRP Day 0 Mean (SD) 6.7 (3.7) 4.8 (2.8)
0.073
DAY10
Mean (SD)
5.0 (3.0) 3.4 (1.6)
0.04*
IntraGroup p value 0.001** 0.015*
Mean Difference 1.7 1.4
* p value <0.05 - Signicant
** p value <0.001 - Highly Signicant
TABLE 4: Analysis of Blood parameters among Severe patients in both the arms n=16
Page 11/16
Day 0 Mean (SD) Day 10 Mean (SD) p value (intragroup)
D-Dimer 956.16 (358.42) 777.07 (249.54)
0.116
CRP 8.45 (3.5) 5.80 (3.0)
0.001**
IL-6 12.86 (7.3) 9.54 (6.3)
0.0003**
Ferritin 1118.15 (446.99) 897.23 (314.22)
0.0016*
* p value <0.05 - Signicant
** p value <0.001 - Highly Signicant
The intervention group reported no adverse events or side effects upon taking NOQ19 daily.
4.0 Discussion
Natural herbs have been widely utilized for viral u and other seasonal infections. However, there is a lack of
research studies on the ecacy of herbs in the management of COVID-19 patients33. To the best of our
knowledge, this is the rst pilot, double blind randomized clinical trial evaluating the 19 ingredient polyherbal
ayurvedic formulation, NOQ19, for the therapeutic management of moderate-severe COVID-19 patients. The
results demonstrated a signicantly early recovery among the NOQ19 arm. All the blood markers
demonstrated a marked level of improvement in both the study arms. However, it was noted that the
improvement was consistently higher in the NOQ19 arm. Although the patients were randomized to different
groups via computer generated sequence of randomization, baseline evaluation of clinical markers in both the
arms demonstrated that the intervention arm had a higher percentage of severely infected patients than the
placebo arm. Our study noticed an improvement in the rate of recovery even among the severe patients in the
NOQ19 arm. However, the placebo arm did not show improvement in any severe patients until day 10.
Ayurvedic medicines are usually tested in mild cases for their ecacy. Our study is the rst of its kind to
examine the effect of NOQ19 in moderate-severe patients who were not on ventilation or ICU.
In addition to objective marker analysis, we were interested in evaluating any side effects or adverse events
that may require discontinuation of the drug in humans. There were no dropouts, side effects or adverse
events in the NOQ19 arm.
In an earlier open label feasibility study on the NOQ19 polyherbal formulation, similar results were noticed with
respect to RT-PCR conversion to negative. Out of 161 patients enrolled in the study, 74% of the patients turned
RT-PCR negative by Day 534.
In vitro
and
in vivo
studies27-28 on the effectiveness of the polyherbal
formulation, NOQ19 also showed signicant viral load reduction. In the
in vitro
analysis of NOQ19, a 100%
viral load reduction was noted in the Vero E6 SARS-CoV-2 infected cell line. The
in vivo
animal study on
infected Syrian golden hamsters demonstrated a 78.2% viral load reduction in hamster lungs compared to the
infected untreated group. Among the researched herbs, Yashtimadhu (
Glycyrrhiza glabra
) has been extensively
studied via
in silico
studies for presence of phytochemicals possessing antiviral properties. Glycyrrhizin, a
Page 12/16
component of Yashtimadhu (
Glycyrrhiza glabra
) has been identied as the chief component responsible for
inhibiting the attachment of SARS-CoV-2 spike protein with the ACE-2 receptors35. Clinical trials on
Ashwagandha
(Withania somnifera
) have demonstrated its immunogenic, anti-inammatory and adaptogenic
properties36. Another placebo controlled trial on Ashwagandha (
Withania somnifera
), Giloy (
Tinospora
cordifolia
) and Tulasi (
Ocimum sanctum
) demonstrated that 71.1% of patient population recovered from
COVID-19 on day 3 in the treatment group. However, only 50% of patients recovered from COVID-19 in the
placebo group. Also, the study noticed that serum CRP level, IL-6 and TNF alpha were 20 times lesser in the
intervention group than the placebo group on day 737. Another study quoted that patients receiving an
Ayurvedic regimen of
Dasamoolkaduthrayam Kashaya
and
Guluchyadi Kwatham
presented with early
recovery and reduced length of stay in the hospital38. Upon further inspection, it was noted that the above
mentioned drugs had Bilwa (
Aegle marmelos
), Pippali (
Piper longum
), Vaska (
Adhatoda vasica
) and Guduchi
(
Tinospora cordifolia
), in common with NOQ19 formulation. Although our study did not capture the details
regarding the duration of hospital stay, the objective markers represent that patients in the NOQ19 arm
recovered well and therefore, did not require a long hospitalization. Another AYUSH drug, Kabasura Kudineer,
has been well studied for its ecacy in symptom recovery and therapeutic cure against COVID-19. Kabasura
Kudineer and Nilavembu Kudineer along with the standard of care treatment were compared against standard
treatment alone for COVID-19. The authors noticed that patients in the intervention group took only 2.7 days
approximately to turn asymptomatic while those with standard of care treatment took 4.2 days39. Our study
demonstrated that the Ayurvedic formulation, NOQ19, expedited COVID-19 recovery, viral load reduction and
clearance, as measured by RT-PCR negative test. Correlating with the viral clearance, the immune markers and
inammatory markers also demonstrated a signicant improvement among patients with severe disease. One
of the key limitations of the study is the small sample size. Further randomized control studies on the
formulation with larger sample sizes can evaluate the effectiveness of the drug in COVID-19 patients.
5.0 Conclusion
This study evaluated the therapeutic ecacy of a 19 ingredient Ayurvedic, polyherbal formulation, NOQ19 for
clinical improvement in COVID-19 patients. A higher rate of recovery was noted in the NOQ19 arm on Day 7
compared to placebo, among moderate-severe patients. The immune markers, inammatory markers and
other blood markers demonstrated a signicant clinical improvement among the patients who took NOQ19,
even among those with severe disease. Additionally, the patients who took NOQ19 experienced no adverse
effects. This study highlights the ecacy of NOQ19, an Ayurvedic formulation, in the management of COVID
19, when administered along with standard care of treatment. Based on this pilot study, further clinical trials
can throw light on the ecacy of NOQ19 in COVID-19.
Declarations
Acknowledgement
We would like to thank Dr Ravi Reddy (Chief Science Ocer) and Dr Hari Venkatesh (Head,Research &
Development – Healthcare) from Sriveda Sattva for providing NOQ19 and placebotablets to the study site
Atharva Multi Speciality and Research Center. We would also like toacknowledgeDr. SomyaRamrakhyanifor
languageedits.
Page 13/16
Conict of Interest:
Allauthorsdeclarethereisnoconictofinterest.
Funding:
No funding was received
Data Availability: The individual patient level data can be accessed at the following link
https://docs.google.com/spreadsheets/d/1keaMxG6JblvyGV1n7EMbK8Yo_WaJbAiPeDj_KTHvpiQ/edit#gid=0
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CONSORT Flow Diagram
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