Randomized placebo-controlled pilot clinical trial on the efficacy of ayurvedic treatment regime on COVID-19 positive patients

Devpura, Ganpat; Tomar, Balvir Singh; Nathiya, Deepak; Sharma, Abhishek; Bhandari, Deepak; Haldar, Swati; Balkrishna, Acharya; Varshney, Anurag

doi:10.1016/j.phymed.2021.153494

Cited by 77 publications

(73 citation statements)

References 31 publications

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“…The recovery response rate in the treatment group was higher than the control group. The probability of delayed healing process from infection in the treatment group was significantly decreased by 40% (Devpura et al, 2021).…”

Section: Tinospora Cordifolia and Piper Longummentioning

confidence: 92%

Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions

et al. 2021

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SARS-CoV-2 is the latest worldwide pandemic declared by the World Health Organization and there is no established anti-COVID-19 drug to combat this notorious situation except some recently approved vaccines. By affecting the global public health sector, this viral infection has created a disastrous situation associated with high morbidity and mortality rates along with remarkable cases of hospitalization because of its tendency to be high infective. These challenges forced researchers and leading pharmaceutical companies to find and develop cures for this novel strain of coronavirus. Besides, plants have a proven history of being notable wellsprings of potential drugs, including antiviral, antibacterial, and anticancer therapies. As a continuation of this approach, plant-based preparations and bioactive metabolites along with a notable number of traditional medicines, bioactive phytochemicals, traditional Chinese medicines, nutraceuticals, Ayurvedic preparations, and other plant-based products are being explored as possible therapeutics against COVID-19. Moreover, the unavailability of effective medicines against COVID-19 has driven researchers and members of the pharmaceutical, herbal, and related industries to conduct extensive investigations of plant-based products, especially those that have already shown antiviral properties. Even the recent invention of several vaccines has not eliminated doubts about safety and efficacy. As a consequence, many limited, unregulated clinical trials involving conventional mono- and poly-herbal therapies are being conducted in various areas of the world. Of the many clinical trials to establish such agents as credentialed sources of anti-COVID-19 medications, only a few have reached the landmark of completion. In this review, we have highlighted and focused on plant-based anti-COVID-19 clinical trials found in several scientific and authenticated databases. The aim is to allow researchers and innovators to identify promising and prospective anti-COVID-19 agents in clinical trials (either completed or recruiting) to establish them as novel therapies to address this unwanted pandemic.

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Section: Tinospora Cordifolia and Piper Longummentioning

confidence: 92%

Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions

et al. 2021

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“…This needs further trial on a large group to be actually established into a valid drug against SARS-CoV-2. Clinical trial of ashwagandha in combination with Swasari Ras, Giloy Ghanvati, Tulsi Ghanvati and Anu Taila was done on mildly affected and asymptomatic patients (Clinical Trial Registry-India -6) and tumor necrosis factor alpha (TNF-a) [9]. All these observations provide a constructive lead towards their usage as drugs or dietary supplement in a dose specific manner for managing the progression of this viral disease.…”

Section: Resultsmentioning

confidence: 99%

Efficacy of phytochemicals as immunomodulators in managing COVID-19: a comprehensive view

Bhattacharya¹,

Paul²

2021

VirusDis.

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Throughout history, disease outbreaks have worked havoc upon humanity, sometimes reorienting the history and at times, signaling the end of entire civilizations and the modern pandemic that the world is dealing with, is COVID-19 or SARS-CoV-2. A healthy immunity could be an ideal gear for resisting COVID-19 for neither medicines nor vaccines have been ascertained till date. In view of the present scenario, there is a demanding necessity to analyze innovative and valid techniques for forestalling and cure of COVID-19 by re-evaluating the structure of the natural compounds for drug designing. The Ayurveda has come forward by prescribing a lot of medicinal herbs for combating this dreaded disease. We have searched from sources in Pubmed and Google Scholar and found 1509 items. The search criteria were limited to the effect of phytochemicals in certain immunomodulatory aspects of viral infection. The original research papers related to the works on phytochemicals in the down regulation of NF-kB, activation of NK and CD8? cells, inhibition of inflammatory cytokine release and ROS scavenging were included in our study. Here, we try to focus on the immunoregulatory cells which have a vital aspect in COVID-19 and highlight the potential effects of the restorative use of phytochemicals as drugs or dietary supplements.

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“…A large effort has been put in by the Ministry of AYUSH, GOI, to validate these drugs (21). A randomized placebo controlled short term study attempted to show a reduction in viral load using a well-designed Ayurvedic regimen (oral drugs and nasal application) in asymptomatic and mild cases of COVID-19; clinical improvement was not properly defined (47). A small sample size uncontrolled observational study showed good resolution of symptoms by AYUSH 64 in patients suffering from influenza like illness (48).…”

Section: Other Studiesmentioning

confidence: 99%

Coadministration of AYUSH 64 as an adjunct to Standard of Care in mild and moderate COVID-19: A randomised, controlled, multicentric clinical trial

Chopra¹,

Tillu

Chaudhary

et al. 2021

Preprint

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Objectives: To compare the co-administration of an Ayurvedic drug AYUSH 64 as an adjunct to standard of care (SOC) and SOC for efficacy and safety in the management of COVID-19. Design: Multicentre, parallel efficacy, randomized, controlled, open-label, assessor blind, exploratory trial with a convenience sample. Patients followed to complete 12 weeks of study duration. Setting: COVID-19 dedicated non-intensive care wards at 1 government hospital, 1 medical college teaching hospital and 1 medical university teaching hospital Participants: 140 consenting, eligible, hospitalized adult patients suffering from mild and moderate symptomatic COVID-19 and confirmed by a diagnostic (SARS-CoV-2) RT-PCR assay on nasal and throat swab were randomized to SOC or SOC plus AYUSH 64. To be withdrawn if the disease becomes severe. Interventions: Two tablets of AYUSH 64, 500 mg each, twice daily after meals, and continued till study completion. SOC (symptomatic and supportive) as per national guidelines of India for mild and moderate disease. Main outcome measures: Time period to clinical recovery (CR) from randomization baseline and proportion with CR within 28 days time frame; CR defined in the protocol Results: 140 patients randomized (70 in each arm); 138 patients with CR qualified for analysis. Both groups were matched at baseline. The mean time to CR from randomization was significantly superior in AYUSH 64 group (95% CI -3.03 to 0.59 days); a higher proportion (69.7%) in the first week (p=0.046, Chi-square). No significant differences observed for COVID-19 related blood assays (such as D-Dimer). AYUSH 64 arm showed significant (p<0.05) superior persistent improvement in general health, quality of life, fatigue, anxiety, stress, sleep, and other psychosocial metrics. 1 patient on SOC required critical care. 48 adverse events (AE) reported in each group. Barring three SAE (in SOC), AE were mild and none were drug-related. 22 participants (8 on AYUSH) were withdrawn. No deaths were reported. Conclusions: AYUSH 64 hastened recovery, reduced hospitalization, and improved overall health in mild and moderate COVID-19 when co-administered with SOC under medical supervision. It was safe and well-tolerated. Further studies are warranted. Trial registration: The Clinical Trials Registry India Number CTRI/2020/06/025557 Funding: CCRAS, Ministry of AYUSH, Government of India

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Randomized placebo-controlled pilot clinical trial on the efficacy of ayurvedic treatment regime on COVID-19 positive patients

Cited by 77 publications

References 31 publications

Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions

Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions

Efficacy of phytochemicals as immunomodulators in managing COVID-19: a comprehensive view

Coadministration of AYUSH 64 as an adjunct to Standard of Care in mild and moderate COVID-19: A randomised, controlled, multicentric clinical trial

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