COVID-19 Management through Ayurveda and Yoga - PowerPoint Presentation

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COVID-19 Management through Ayurveda and YogaFocus on Research and Development

N Srikanth

Director General (Additional charge)Central Council for Research in Ayurvedic Sciences Ministry of AYUSH, Govt. of India

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Ayurvedic perspective of COVID-19

A

s per Ayurveda classical texts, COVID-19 may be considered as - Janapadodhwamskara (epidemics/pandemic) -

Oupasargika

Roga

(contagious disease)

Measures to

mitigate the epidemics

described in Ayurvedic texts

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Ayurvedic perspective of COVID-19

COVID-19 can be correlated to Vata-kaphaja Jwara as mentioned in Ayurveda classical texts

The symptoms of Vata-kaphaja Jwara include Pratishyaya (common cold), Kasa (cough), Santapa (fever), Tandra (lassitude), Shiro-Ruk (headache), etc. which can be correlated to the clinical presentation of COVID-19 Ayurveda medicines play significant role in immunomodulation

and thereby have the potential to decrease the risk of disease worsening and mortality.

Ayurveda has wide scope in the prophylaxis and management of this disease condition

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MoA Initiatives during COVID-19

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PUBLIC HEALTH ADVISORIES

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GUIDELINES ON COVID-19

Practitioners Guidelines

General Research Guidelines

Specific guidelines for clinical studies on COVID-19

Telemedicine Guidelines

Guidelines for Practitioners for COVID-19 Patients in Home Isolation

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National Repository on AYUSH COVID-19 Clinical and Other R&D Initiatives

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AYUSH COVID-19 Dashboard

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Utilization of AYUSH Infrastructure and Human Resource

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Impact assessment of effectiveness, acceptance and usage of AYUSH advisories & measures in prevention of COVID 19: A mobile app based population study

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Distribution campaign of Ayush medicines for COVID-19 prophylaxis in

more than six

lakh geriatric populationNational campaign to distribute AYUSH-64/ Kabasura Kudineer

to

92,000

asymptomatic and mild to moderate COVID-19 cases in home isolation

Ayuraksha

kit distributed to

80,000

Delhi Police Personnel

Prophylactic AYUSH medicines to

general

population and residents of containment zones

Prophylactic AYUSH Medicines to

Healthcare Workers

Specialized FLU and Post-COVID OPD

Distribution of

Ayush

Prophylactic Medicines

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COVID Health Centre – All India Institute of Ayurveda

Total patients received and completed

Ayurveda

standalone

treatment: 545

Average recovery period observed: 10 days

Mortality rate is 0.18% (1 patient)

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Interdisciplinary AYUSH R & D Task Force

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Rationale –Repurposing

Recommendations of I

nterdisciplinary AYUSH R & D Task Force Quality Standards Evidences on clinical and pre-clinical safety Evidences on symptom management (ILI) /Anti-viral /Immunomodulatory activity

Molecular Docking studies

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AYUSH Research Studies on COVID-19

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AYUSH System-wise COVID-19 Studies

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RESEARCH STUDIES IN COVID-19

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AYUSH-CSIR Collaboration Studies on COVID-19Based on recommendations of I

nterdisciplinary AYUSH R & D Task Force

Clinical studies on four different Ayurveda interventionsAshwagandha for prophylaxis Yashtimadhu, Guduchi-Pippali and AYUSH-64

as adjunct to standard of care for COVID-19 management

.

Periodically reviewed by an independent Monitoring Committee.

Trial related activities audited by an independent clinical trial auditor.

All the four studies have been completed.

Manuscript of AYUSH-64 study has been submitted in a high impact journal.

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Ashwagandha as Prophylactic intervention in Healthcare workersStudy Design:

Randomized, active control, open label, parallel efficacy, two-arm multicentre study

Sample Size: 400 (200 in each group)Participants: Healthcare workers with negative RT-PCR for COVID-19 and SARS-CoV-2 antibodies (IgG)Intervention: Ashwagandha (Withania somnifera) 500 mg extract twice daily

Control:

Hydroxychloroquine

Sulphate

800 mg loading followed by

400 mg weekly

Study Period:

16 week

CTRI/2020/08/027163

Study outcomes

Ashwagandha was non-inferior to HCQ

in the chemoprophylaxis against COVID-19 in HCW

Ashwagandha

has a superior safety profile as

significantly more AE in the HCQ group compared to

Ashwagandha

Several health measures particularly

anxiety and stress

improved significantly in

Ashwagandha

arm

Four participants in WS and 5 in HCQ arm developed confirmed COVID-19

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Evaluation of the immuno-stimulatory potential of Ayurveda management protocol in cohort of Delhi police -

An exploratory study

Study intervention:

Ayurraksha

kit (

Samshamani

vati, AYUSH

kadha

,

Anu

taila

Nasya)

Sample size:

80,000 Delhi police personnel

90% compliance observed

Significant decrease in the incidence and mortality rate in Delhi Police personnel compared to general public of Delhi

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Impact of Ayurvedic Interventions in prevention of COVID-19 in identified containment area of Delhi

Comparison of incidence of COVID

– 19 in containment zones of Delhi under study v/s general population of Delhi (Reference : https://covid19-indialive.easocare.com/)

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An Open label, Randomized, Community based Study to evaluate safety and efficacy of

Guduchi Ghan Vati

as a Preventive Remedy in Healthy Individuals during COVID-19 Study Site: 06 containment areas of Rajasthan, IndiaSample Size: 10,428Intervention:

Guduchi

(

Tinospora

cordifolia

Willd

Miers

)

Ghan

Vati 1 gm BD for 45 days

Study outcomes

Lower Incidence of COVID-19 in GGV Group (

p=0.11)

Severity of illness (Non COVID- 19) was significantly lesser in GGV Group (p=0.05)

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A prospective non-randomized open label study on Guduchi as prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19

Incidence of COVID-19 infection in trial group v/s control group

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Prospective non randomized open label control study on Ayurvedic Raksha Kit (Chyawanprash, Samshamani vati

& Haritaki) as prophylactic measure among police personnel working in the vicinity of COVID -19 facilities

Incidence of COVID-19 infection in trial group v/s control group

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Prospective non randomized open label study on Ayurvedic Raksha Kit-1 (Ayush 64, Guduchighan vati

& Chyawanprash) as prophylactic measure among Ayush healthcare workers working in the COVID -19 facilities

Incidence of COVID-19 infection in trial group v/s control group

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Evaluation of the efficacy of an Ayurvedic intervention (Chyawanprash) in the prevention of COVID-19 pandemic among Health Care Personnel – An open label single arm prospective study

Trial Site - A&U

Tibbia College, DelhiSample size – 50Study OutcomesProtection rate was 98.91% in prevention of COVID-19 during treatment with Ayurveda intervention comparing the incidence of the COVID-19 in three periods (before, during and after treatment). Significant change seen in the IL-6 and IL-10 levels.

Infection rate at the study setting before, during and after treatment

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A prospective open label controlled interventional study on the effect of Ayurvedic

intervention (Ayurveda

Raksha Kit) as a prophylactic measure in the Pandemic of COVID-19 - A community based study Study site: 20 peripheral institutes of CCRAS

Sample Size:

Control group:22000, Intervention group: 1,78,000

Lower incidence of COVID-19 symptoms in the Ayurveda intervention group observed

during each of the follow-up visits

Control Group-

Standard preventive measures for COVID-19

Intervention group- ‘

Ayurveda

Raksha

Kit’

(

Chyawanprash

- 6 gm OD,

Ayush

kwath

40 ml

OD

,

Samshamani

Vati

- 250mg BD,

Anu

taila

for instillation BD)

along with Standard preventive measures for COVID-19

Intervention period:

1 month

Intervention Group

Control Group

Participants undergone testing for COVID-19

during 45 days

of trial

5900 out of 151893

(3.88%)

465 out of 21309

(2.18%)

Participants tested Positive for COVID-19

during 45 days

of trial

82 out of 5900

(1.38%)

7 out of 465

(1.50%)

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TREATMENT STUDIES

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Study Outcomes:Participants treated with AYUSH-64 recovered early

(6.5 ± 2.4 days) compared to standard care (8.3 ± 4.4 days

)More patients from AYUSH-64 group (69.75%) recovered within one week of randomization than those on standard care (52.9%).Mean time to negative RT-PCR was lesser in AYUSH-64 group (7.50 ± 3.33 days

) compared to standard care (

8.39 ± 4.83

days)

No SAE reported in the AYUSH-64 group.

AYUSH-64 as Adjunct Treatment to Standard of Care in Mild to Moderate COVID-19

AYUSH-CSIR collaborative study

Study design:

Randomized, open-label, active control, multi-centre exploratory trial

Sample size:

140

Intervention:

AYUSH-64 along with SOC

Control:

Standard of care

Treatment period

:

12 weeks

CTRI/2020/06/025557

No. of days for clinical recovery

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Ayurvedic intervention as add-on to standard of care in COVID-19 in a Tertiary Hospital

Study Design: Randomized controlled trialTrial Site: Medanta Hospital, Gurugram

Sample Size:

60 (30 in each group)

Intervention:

Guduchi-Pippali

along with SOC

Control:

Standard of Care

Treatment period :

Till discharge from hospital

CTRI/2020/04/024882

Study outcomes

No patient progressed to critical stage in Ayurveda add-on group.

All the patients in the Ayurveda add-on group turned asymptomatic till 6th day; whereas only 40% turned asymptomatic in the control group.

Mean duration of hospital stay was less in Ayurveda add-on group (

5.5±2.4 days

) compared to control group (

6.9± 3.08 days

)

Clinically, no drug-herb interaction reported

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A Randomized, open label, parallel efficacy, active control trial to evaluate the efficacy and safety of an Ayurvedic Formulation (AYUSH 64) as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients

Study Site:

Shri Dhanwantri Ayurvedic College, ChandigarhSample Size: 80 (40 in each group)

Intervention:

AYUSH-64 along with SOC

Control:

Standard of care

Study Period:

30 days

CTRI/2020/05/025214

Study outcomes

Statistically significant difference in the proportion of participants with clinical recovery

at each of scheduled follow-up visits

(AYUSH-64- 100%; SOC- 32.4% on day 23)

Compared to control group

Proportion of participants with negative RT-PCR was better in Ayush-64 group on all

follow-up visits

Proportion of participants with improvement in HRCT chest was also statistically significant in the AYUSH-64 group

(p=0.031)

.

AYUSH-64 significantly reduced the levels of pro-inflammatory markers

(

p<0

.

05

)

.

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Evaluation of Efficacy and Safety of Ayush-64 add-on-therapy for patients with Covid-19 (Stage-I)- A Randomized controlled trial

Study Site:

Government Medical College, NagpurSample Size: 60 (30 in each group)

Intervention:

AYUSH-64 along with SOC

Control:

Standard of care

Study Period:

30 days

CTRI/2020/05/025156

Study outcomes

Clinical recovery was better at 15

th

day in the AYUSH-64 group (60%) compared to standard of care (37%)

Clinical recovery in all the participants (100%) of the AYUSH-64 group on 30

th

day whereas it was 85.2% in the control group.

Reduction in the levels of IL-6, D-

dimer

and TNF-α was statistically significant in the AYUSH-64 group

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Evaluation of Efficacy and Safety of AYUSH-64 add-on therapy for patients with COVID-19 infection (Stage I)-An Open label, Randomized controlled trial

Study Site:

AIIMS Jodhpur

Sample Size:

60 (30 in each group)

Intervention:

AYUSH-64 along with SOC

Control:

Standard of care

Study Period:

30 days

CTRI/2020/06/026002

Study outcomes

Proportion of participants with negative RT-PCR was more in

AYUSH-64

group (70%) compared to standard of care (53.33%)

Clinical recovery was earlier in

AYUSH-64

group

No ADR reported

No patient progressed to critical stage in

AYUSH-64

group

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A Pilot study to assess the efficacy of AYUSH-64 in mild to moderate COVID-19 cases

Study Site:

CBPACS, New DelhiSample Size: 40Intervention: AYUSH-64

Study Period:

14 days

CTRI/2020/05/025425

Study outcomes

86.1% participants showed clinical recovery after 14 days of intervention.

69.4% participants turned RT-PCR negative on 15th day

Rest of the participants recovered in due course. No events of mortality/ progression to critical stage observed.

No ADR/AE reported.

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Evaluation of Efficacy and Safety of Ayush-64 in the management of COVID-19 (Asymptomatic & Mild to Moderate)- An open label single arm clinical trial

Study Site:

A&U Tibbia College, New Delhi

Sample Size:

40

Intervention:

AYUSH-64

Study Period:

14 days

CTRI/2020/05/025338

Study outcomes

Mean time for clinical recovery was 7.04 days (± 2.88 days)

All participants (100%) turned RT-PCR negative until 15th day

61.1% and 97.2% participants clinically recovered in 07 and 14 days respectively

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A Prospective Randomized Controlled Trial to evaluate the Efficacy and Safety of Guduchi Ghan Vati in the management of COVID-19 (Asymptomatic & Mild to Moderate cases)

Incidence of RT-PCR negative for COVID-19 on 10

th day

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A Prospective Randomized Controlled Trial to evaluate the Efficacy and Safety of Ashwagandha Tablet and Shunthi

Capsule in Mild to Moderate COVID-19

Better proportion of participants from Ayurveda intervention group (79.3%) turned RT-PCR negative on 7th day of randomization compared to standard care (60.7%). Better clinical improvement in the

Ayurveda

group corresponding to the RT-PCR results.

No significant SAE/ADR reported.

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Site: Samaras COVID care center, Ahmadabad, Gujarat, IndiaStudy interventions: Along with conventional care, Ayurveda protocol comprising of

Dashamula+Pathyadi kwatha with Trikatu

, Sanshamani vati, AYUSH -64 tablet, and Yastimadhu Ghana tablet. Study period: 15th April to discharged or referred up to 31st May 2020Study Outcomes: No appearance of COVID-19 symptoms in asymptomatic COVID-19 patients.Early clinical recovery observed in symptomatic COVID-19 patients in the Ayurveda add-on group.

No events of mortality/ progression to critical stage observed.

No ADR/AE reported.

Clinical outcome of

Ayurveda

treatment on COVID -19 patients: a retrospective cohort study

(n=541)

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A Randomized controlled trial to evaluate the efficacy of Ayurvedic interventions (

Agastya

Haritaki and Ashwagandha) and Yoga in long term effects of COVID-19 Study Site: Govt. Medical College, Nagpur and J N Medical College, DMIMS,

Wardha

Sample Size:

220 (132 participants enrolled till date)

Intervention:

Agastya

Haritaki

and Ashwagandha

Intervention period:

90 days

Control:

WHO Rehabilitation Self-Management after COVID-19- Related Illness guidelines.

Outcome measures:

Change in respiratory function, HRCT Chest, Modified Fatigue Impact Scale, HADS Score, Pittsburgh Sleep Quality Index, Quality of Life (COV19-QoL)

Study Ongoing

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Documentation of efficacy of Ayush-64 and Kabasura

Kudineer in asymptomatic and mild to moderate COVID-19 patients in home isolation through a mobile app: A prospective multicenter Community based study

The study objective is to reduce the burden on the hospital-based healthcare delivery systemParticipants: Asymptomatic and mild to moderate COVID-19 patients in home isolation. Ayush-64: Asymptomatic cases- 2 tablets (500 mg each) BD; Mild to moderate COVID-19: 2 tablets TDS

Kabasura

Kudineer

:

60 ml BD

Intervention period:

20 days

CTRI Registration:

CTRI/2021/05/033623

Study coordinating centers -

87

92,000 subjects enrolled

The data is documented through AYUSH

Sanjivani

mobile application.

Study completed; Data analysis under process

Interim trends shows no participant required hospitalization.

Further, RT-PCR negative by

7th day: 49.7%

14

th

day: 84.1%

21st day: 91.1%

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Pre-clinical studies

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In-silico evaluation of compounds of an Ayurvedic drug, AYUSH-64, for their action against SARS-CoV-2 Main Protease

Study site: ICMR-National Institute of Nutrition, Hyderabad Evaluation of different compounds available in Ayush-64 against SARS-CoV-2 Main Protease (Mpro) via computational molecular docking.Outcomes: Out of 36 compounds of AYUSH-64 screened,

35 compounds exhibited good binding energies than the positive control of N3

among, the best affinity and interactions of

Akuammicine

N-Oxide

towards the target with binding energy (Auto Dock

Vina

) of -8.4 kcal/mol and

Libdock

score of 147.92.

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DBT-AYUSH Network Projects on COVID-19

Objective:

Preclinical and pharmacokinetics evaluation of select AYUSH Herbal extracts/formulations for mitigating SARS-CoV-2Study Site: Translational Health Science and Technology Institute, Dept. of Biotechnology, Govt. of IndiaHerbal Extracts: Ashwagandha

Guduchi

Guduchi

-Pippali

Yashtimadhu

AYUSH-64

Swertia

chirata

,

Picrorhiza

kurroa

,

Alstonia

scholaris

and

Caesalpinia

bonducella

Nasal formulations:

Anu

Taila

,

Shadbindu

Taila

,

Tila

Taila

& Go Ghrita.

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Immunomodulatory

Activity

II. Anti-Viral Activity:

Evaluation of Cov-2 replication

in vitro

Syrian hamster model

hACE2

Tg

mice model

Pseudovirus

model in

Balb

/c mice

III. Preclinical Studies in Animal Models of co-morbidities

(Obesity and diabetes, Pulmonary

thromboembolism

)

IV. Pharmacological and Toxicity Studies

V.

In vitro

Pharmacokinetic studies

(with anti-viral drugs used for treatment of Covid-19)

All the herbal extracts/ formulations showed effect against SARS-CoV-2 infection.

Anu

taila

showed better result in combating the effect of SARS-CoV-2 infection as seen by low

viral load in lungs in the Golden Syrian hamsters challenged with SARS-CoV-2.

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In-silico

study of RdRp

and Mpro of SARS-CoV-2 to find its inhibitor from the ingredients of AYUSH KwathaStudy Site: IIT Varanasi (BHU)Main protease (M

pro

)

and

RNA dependent RNA polymerase (

RdRp

) are used as

a

potential targets for screening

the

herbal compound.

The study involves the use of computational tools to analyze

ligands

, and SARS-Cov-2 proteins target

M

pro

and

RdRp

.

Study Outcomes

The study showed Beta-

Sitosterol

, a component of

AYUSH

Kwatha

is a common and potential inhibitors of

M

pro

and

RdRP

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YOGA IN COVID-19 Prophylaxis

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Efficacy of Pranayama on Positivity rate in people exposed to COVID-19 Patients and mental status

Study Design: Randomized controlled pilot study Intervention: Two Pranayama sessions- 30 minutes (in morning) and 15 minutes (in evening)

Subjects:

280 Health Care Professionals (Duty in COVID-19 wards/hospitals)

Study site:

5 COVID Care Centers/Quarantine Centers

Study Outcomes:

Less incidence of COVID-19 in the experimental group (highly significant) compared to control group after 28 days of intervention.

COVID-Positive

Cases

COVID-Negative

Cases

Chi Score

P-Value

Pranayama

Group:

n

(%)

1 (0.004%)

122

6.4

0.01

Control Group: n

(%)

9 (0.036)

118

510.4

Post Intervention Rapid Antibody Test for COVID-19

Slide49

Dissemination of Outcomes of Research Studies

MoA

constituted an Advisory panel to facilitate AYUSH researchers in disseminating the outcomes of the research studies on COVID-19 through scientific publications in journals of high repute. The panel include eminent researchers and senior faculty of various disciplinesManuscripts drafted- 78Manuscripts published- 20Manuscripts Accepted for publication – 09

Manuscripts submitted to indexed Journals- 41

Manuscripts available as Preprints – 26

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PUBLISHED ARTICLES

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PUBLISHED CASE REPORTS

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Prophylactic Ayurveda studies on COVID-19 at a glance

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Therapeutic Ayurveda studies on COVID 19 at a glance

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National Clinical Management Protocol based on Ayurveda and Yoga for Management of COVID-19

MoA set-up an Interdisciplinary Committee for Integration of Ayurveda and Yoga Interventions in the 'National Clinical Management Protocol: COVID-19 Based on NITI Aayog and ICMR recommendations on the committee report, the MoA issued the National Clinical Management Protocol based on Ayurveda & Yoga for management of COVID-19 enabling uniform clinical management

The protocol is for the

prophylaxis, management of asymptomatic and mild COVID-19 cases and post-COVID care

.

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THANK YOU