Summary of Research on Sri Sri Tattva NOQ19/NF2


Executive Summary

The coronavirus disease 19 (COVID-19) pandemic is unprecedented and has posed a humongous global challenge to human health and the entire healthcare system. At present several allopathic drugs are under investigation for treatment of coronavirus disease, but they are failing to contain the spread of virus effectively. No allopathic drug has been proven as a cure so far.

Ayurveda, the traditional system of medicine practiced in India can be traced back to 6000 BC. It is one of the ancient living traditions. There has been an increased global interest in ayurvedic solutions for modern health challenges. In Ayurveda many treatment options are available which can increase immunity against respiratory infections. Indigenous medical systems use specific polyherbal formulations for the treatment of such infections with considerable success. Evidence-based research in Ayurveda is receiving larger acceptance in India and abroad.

It is necessary to explore holistic cures for COVID-19 because of the increased side effects, adverse drug reactions and cost of the western medicines. In this report, we bring to your notice an unique drug formulation, Sri Sri Tattva’s NOQ19, based on ancient ayurvedic wisdom which has great potential to emerge as a therapeutic option, as well as a prophylactic for COVID-19.

A polyherbal ayurvedic formulation, Sri Sri Tattva NOQ19, that have been known and proven for their strong antiviral effects combined with immune enhancing and modulating effects. .


NOQ19 composition contains following 13 herbs which have beneficial properties effective against various symptoms of SARS-CoV-2.


Common Name Scientific Name Useful Therapeutic Properties proposed/tested during outbreak of SARS-CoV-2
Ashwagandha Withania somnifera Analgesic, mildly sedative, anti-inflammatory and anabolic activities and it is useful in stress, strain, fatigue, pain, chronic fatigue syndrome, etc and even during pregnancy without any side effects, anti SARS-CoV-2 activity in computational study
Bilwa Aegle marmelos Treatment of chest congestion, cold, cough and sinusitis, anti inflammatory, immunomodulatory and antiviral properties. computational study showed that seselin from Aegle marmelos inhibited the replication of the SARS-COV-2 viruses.
Yashtimadhu Glycyrrhiza glabra Anti-inflammatory, anti-bacterial, anti-fungal, anti-diabetic, antiviral, anti-ulcer, antitussive, anti-oxidant, inhibits the growth of viruses including herpes simplex, Varicella zoster, and of Japanese encephalitis, influenza virus, vesicular stomatitis virus, type A influenza virus. Glycyrrhizin does not allow the virus cell binding. Recent study on two clinical isolates of SARS virus (Severe Acute Respiratory Syndrome virus) [FFM-1 and FFM-2] gave valuable insight about anti-viral activity of glycyrrhizin.
Vasaka Adhatoda vasica Antiviral, hepatoprotective, antitussive,antibacterial, anti-inflammatory, antitubercular, antioxidant, antimutagenichave, its immunomodulatory properties.
Pippali Piper longum Appetizer, beneficial for the throat, anti-saturative, an adjunct to decoction enema, a cleansing nasal therapy, anti colic, a rejuvenator, Bio-availability enhancer, immunomodulatory, anti-asthmatic and hepatoprotective activity, immuno-suppressant, stimulant effect, hepatoprotective, Hypocholesterolemia activity, anti-inflammatory, anti-amoebic and antibacterial.
Patha Cissampelos pareira Treatment of cold , cough and respiratory disorders. It also shows the anti viral and antibacterial properties.
Haridra Curcuma longa Relives worm and microbial infection,powerrfulanti bacterial, anti inflammatory and anti allergic herb, treat gastrointestinal upset, arthritic pain and liver ailments,anti inflammatory, anti oxidant.
Bhumiamla Phyllanthus fraternus Treatment on fever, inflammation of liver and spleen, jaundica and skin diseases. It is also indicated in anemia, asthma and chronic respiratory disorders.
Bhunimba Andrographis paniculata analgesic, antipyretic,antiulcerogenic,antineoplastic, antiinflammatory, antibacterial andantiviral activities.
Saptaparna Alstonia scholaris It detoxifies and cleanses blood. It is beneficial in treatment of wound, intestinal worms, fever and asthma. Antiviral.
Tulasi Ocimum sanctum Treatment of epilepsy, asthma or dyspnea, hiccups, cough, skin and haematological diseases, parasitic infections, neuralgia, headache, wounds, and inflammationand oral conditions.
Guduci Tinospora cordifolia Immunomodulators, antidiabetic medicine, anti allergic, anti leprotic and anti inflammatory agents, SARS-CoV-2 inhibitor under in vitro and animal studies.


Some of the compounds mentioned above have been shown to have stronger binding capacity than Remdesivir in a molecular docking study in response to viral infection.

As the world struggles with COVID-19 due to lack of a cure or a vaccine, our research explores the efficacy of NOQ19 as therapeutic and prophylactic option. It also explores the efficacy of NOQ19 to serve as an adjuvant to increase the efficacy of the vaccine and serve as a potent prophylactic on its own.

If a solution is found through Ayurveda for the current pandemic, it will propel India and its traditional wisdom to global center stage. This is the time to share the science of ayurveda with the world and this effort to create and test NOQ19 is a giant step in that direction.

Research Studies completed / in progress:

Preliminary research studies conducted on mild and moderate COVID-19 patients have demonstrated NOQ19’s efficacy to reduce the recovery time and bring back health quickly to COVID-19 patients.

Based on these observations several clinical and in vitro studies were conducted in reputed Indian institutes.


These include:
1 In vitro studies on cell lines to assess cytotoxicity and antiviral efficacy in SARS CoV2 cell lines
2 Preclinical study in animal models
3 Clinical Trials on COVID-19 patients (mild and moderate)
4 A study to assess if the formulations can enhance the antibody response for the vaccine
5 Gene expression studies to understand mechanism of action

KEY FINDINGS

Our studies ranged from testing the efficacy of medicine as a therapeutic option and/or as a vaccine. A large gamut of research studies were conducted that explores the therapeutic and prophylactic aspects of this medicine.

Some of the key findings from first few studies on NOQ19 are,










Research Studies on NOQ19



Research Study - 1

An In-vitro Evaluation of an Ayurvedic Formulation, NOQ19 against SARS-CoV-2



Study Site

Foundation of Neglected Diseases (FNDR), Bengaluru

Objective

The present study evaluates antiviral activity of the formulation (NOQ19) against SARS-CoV-2 in a Vero E6 cell line in an in vitro setting as further exploration of the antiviral activity of NOQ19.

Design

The Vero 6 cell line was infected with SARS-CoV-2 virus which can kill the cells and make plaques(The more the virus kills, more plaques are formed).

The different concentrations of interventions (positive control - Remdesivir and test - NOQ19) were added and inhibition of plaque formations was studied.


Conclusion

The IC-50 or the inhibiting concentration was found to be 0.2mg/ml for the NOQ19, compared to 0.8 mg/ml for remdesivir (positive control).

IC-50 represents the concentration of a drug that is required for 50% inhibition in vitro. It represents the potency of the drug. Lower the IC-50 value, more potent the drug is.




Click here to go to preprint.



Research Study - 2

The In-vivo Efficacy and Safety of AYUSH Polyherbal Formulation among COVID-19 Infected Syrian Golden Hamsters



Study Site

Foundation of Neglected Diseases (FNDR), Bengaluru

Objective

The objective of this study is to evaluate the in vivo therapeutic efficacy of NOQ19 was, in a SARS CoV-2 infected Syrian golden hamster (Mesocricetus auratus) model.

Design

A total of 19 female Syrian hamsters (Mesocricetus auratus) were infected with the virus cell culture through intranasal route.

4 out of 19 animals were mock controls, 5 were infection controls, 4 were treated with remdesivir and acted as positive controls and remaining 6 were treated with NOQ19.

The hamsters were observed to note body weight reduction and adverse events followed by sacrifice on day 4 after inoculation with the virus. Thereafter, the lung pathology and viral load was studied in each hamster.

Conclusion









Click here to go to preprint.



Research Study - 3

Rate of Recovery and Symptomatic Efficacy of a Polyherbal AYUSH Formulation in the Treatment of SARS- CoV-2 Disease: A Single-Arm Trial.



Study Site

Sri Sri Institute for Advanced Research (SSIAR), Bengaluru

Objective

The present observational study investigates the efficacy of an Ayurvedic polyherbal formulation of 19 ingredients, namely NOQ19, in the management of COVID-19.

Design

A single arm, single centric, open label study design was adopted for this feasibility study. 161 RT-PCR positive COVID-19 patients were enrolled. The enrolled participants were provided the Ayurvedic intervention, 2 tablets of NOQ19, thrice daily along with the standard of care treatment . Follow up COVID-19 RT- PCR tests were conducted on Day 5, Day 10 and Day 14, or until the patient turned negative. The time required for testing negative on the RT-PCR test or becoming asymptomatic was noted.

Conclusion

74% of patients turned RT-PCR negative within 5 days of taking NOQ19, respectively, in addition to the standard of care treatment of Vitamin C, Zinc and antipyretic (as necessary)
98% of patients turned RT-PCR negative within 10 days of taking NOQ19, respectively, in addition to the standard of care treatment of Vitamin C, Zinc and antipyretic (as necessary)
Rapid reduction in symptoms




Click here to go to preprint.



Research Study - 4

An Integrative Approach for Clinical Recovery among COVID-19 Patients using an Ayurvedic Formulation : A Multi-Centric Double-Blind Randomized Control Trial.



Study Site

1.All India Institute for Medical Sciences (AIIMS), Jodhpur

2.All India Institute for Medical Sciences (AIIMS), Rishikesh

3.Sri Manakula Vinayagar Medical College and Hospital (SMVMCH) , Puducherry

Objective

A double blind multicentric study was conducted to observe the rate of recovery among patients in NOQ19 and Placeboarms,usingtheRT-PCR negative test.

Design

A total of 76 patients with positive COVID-19 infection were enrolled with 39 in NOQ19 arm and 37 in Placebo arm. Patients were randomized and blinded to their respective intervention along with standard care of treatment. Assessment of the outcomes was conducted on Day 0,3,5 and 7 for RT-PCR analysis measuring the rate of recovery. Blood markers were analysed on Day 0 and Day 7.

Conclusion

. Mean time to negative RTPCR in the NOQ19 group was 4.8 (95%CI: 4.2-5.5) days as compared to 5.1 (95%CI: 4.5-5.8) days in control group.
. Patients with moderately severe disease, mean time to negative RTPCR in the NOQ19 group was two days lesser than the placebo group. (3.5 days as compared to 5.5 days).
. Patients experiencing breathlessness also had faster in NOQ19 arm compared toplacebo arm (3.3 days in NOQ19 arm compared to 4.3 days inplacebo arm).
. The mean time for resolution for the need for oxygen support was reduced swiftly in the NOQ19 arm versus placebo arm. (3.8 days in the intervention group as compared to 5.0 days).
. NOQ19 patients reported no side effects or adverse events upon consumption.


Research Study - 5

The Efficacy of An Ayurvedic Polyherbal Formulation in the Symptomatic Management of Mild COVID-19 Cases: A Double-Blinded, Randomized Controlled Trial.



Study Site

Sri Sri College of Ayurvedic Science & Research Hospital, Sri Sri University (SSU) - Cuttack, Orissa

Objective

The objective of this clinical trial is to investigate the efficacy of NOQ19, provided in addition to the standard therapy, for patients with mild COVID 19, by specifically measuring the symptomatic parameters.

Design

NOQ19 is poly herbal Ayurvedic formulation consisting of 19 ingredients from 13 herbs. 50 patients with confirmed symptomatic or asymptomatic case of COVID-19, reporting to the study site were invited to participate in a double blinded, randomized placebo-controlled clinical trial. The study duration was around 3 months, and the intervention period for an individual patient was 10 days.

Conclusion

. The patients in the NOQ19 arm noticed rapid recovery with 76% of the patients turning negative within 5 days whereas none of the patients had turned negative in the placebo arm by day 5.
. A significant relief in all the COVID-19 related symptoms were noticed in the NOQ19 group such as fever, dry cough, sputum formation, sore throat, running nose, shortness of breath, fatigue, joint pain, loss of smell and loss of taste by Day 5.
. By Day 10, 100% of the population in the NOQ19 arm showed a complete recovery from all symptoms, unlike the control arm.
. No side effects were observed in the NOQ19 arm during the entire study duration.


Research Study - 6

Evaluation of an Ayurvedic Formulation in Clinical Recovery of COVID-19 Infected Patients: A Double Blind Randomized Study.



Study Site

Atharva Multi-Specialty Hospital and Research, Lucknow

Objective

The present study investigates the efficacy of an Ayurvedic formulation, NOQ19, on the rate of recovery and clinical improvement from COVID-19 among moderate-severe infected patients. None of the severe patients were on ventilation or in ICU.

Design

The study employed a placebo controlled randomized trial with 1:1 ratio among intervention and placebo arm. Participants were given respective intervention along with standard of care and followed up on Day 7 and Day 10 for rate of recovery and clinical improvement. The primary outcome was rate of recovery based on viral load reduction, RT-PCR negativity rate. The secondary outcome included the clinical improvement among patients as calculated by blood biomarkers.

Conclusion

. NOQ19 arm were more severely infected than the patients in the placebo arm, despite randomization, as explained by Berkson’s bias.
. Patients in the severe category receiving NOQ19 arm showed (23.08%) improvement and recovery by day 7 and day 10 while placebo arm did not show any recovery among severe patients until day 10.
. The immune markers, inflammatory markers and other blood markers demonstrated a significant clinical improvement among the patients who took NOQ19, even among those with severe disease.
. IL-6 reduced by 2.2 units in the NOQ19 arm while only by 1 unit in the placebo arm.
. The reduction in D-Dimer was twice more in the NOQ19 arm compared to the placebo arm. (107 units compared to 51.5 units).
. Similarly the reduction in S-ferritin was twice more in the NOQ19 arm compared to the placebo arm. (140.4 units to 86 units).
. The study noticed no adverse events among subjects in the NOQ19 arm.


Research Study - 7

Ayurveda and Management of COVID-19 in Rural Indian Population : A Prospective, Double Blind, Randomized Control Trial .



Study Site

Doctors For You (DFY)-Community Care Center- Konnanuru, Hassan, Karnataka

Objective

The study explored the efficacy of a 19 ingredient ayurvedic polyherbal formulation called NOQ19 on recovery of mild , RT-PCR positive COVID-19 patients.

Design

This was a prospective , double blind , randomized control trial on 92 RT-PCR positive mild cases of COVID-19. The patients were enrolled from rural areas of Karnataka, a state in India. The patients were randomized in 1:1 ratio and NOQ19 and placebo were provided to the respective groups along with standard of care treatment(SOC). The trial took place at Community Care Center, Konnanuru, Hassan, Karnataka. The study duration was around 2 months and the followup period for an individual patient was 10 days. RT-PCR analysis was done on baseline, Day 3,7 and 10. Blood markers indicating inflammation were assessed at baseline, Day 3 and Day 7.

Conclusion

. NOQ19 + SOC arm showed a greater percentage of population who were Rt-PCR negative as compared to the Placebo + SOC arm.
. NOQ19 + SOC arm shows a pattern of early recovery as compared to the Placebo + SOC arm.