Guduchi Ghanavati to Improve Immune Status and General Health in the Population at High Risk of COVID-19: Results of An Open-Label Non-Randomized Clinical Trial from India

Thakar, Anup B; Panara, Kalpesh; Shah, Harshit; Kalsariya, Bharat; Ruparel, Sweety; Jain, Neha; Bhatt, Parloop; Jani, Dilip; Dodia, Rajendrasinh; Patel, Falgun; Salve, Rohan Suryakant; Chaudhari, Swapnil; Raghavani, Hemang Umedbhai; Vyas, Jatin M.; Goyal, Mandip; Bhinde, Sagar

doi:10.2139/ssrn.3798254

Cited by 2 publications

(7 citation statements)

References 12 publications

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“…18,19,27 Out of 3 NRSIs, 1 study had a high risk of bias associated with the selection of participants and measurements of the outcomes 20 whereas other studies had some concerns (Figure 3). 21,28 No study had a low risk of bias in this systematic review. We also reported outcome wise risk of bias of the included studies and presented them in the supplementary file.…”

Section: Quality/risk Of Bias Of Included Studiesmentioning

confidence: 99%

“…One report was excluded during the data extraction process, which used AYUSH interventions as a comparator, 16 finally 12 manuscripts were included. [17][18][19][20][21][22][23][24][25][26][27][28] Detail description of the study selection and elimination process has been depicted in figure 1. All the articles were in the English language only.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…23 In the prophylactic domain, 1 RCT reported the benefit of Chyawanprash 27 and 1 NRSI of Guduchi Ghanavati. 28 All therapeutic trials included mild to moderate disease illness only. No study reported on severe or critical illness.…”

Section: Figure 1: Prisma Flow Chartmentioning

confidence: 99%

“…One prophylaxis study was conducted on individuals at very high risk of exposure (health care professional) 27, and one community trial was conducted on moderate to very high-risk populations. 28 Out of 12, 10 trials were conducted inpatients hospital setting.…”

Section: Figure 1: Prisma Flow Chartmentioning

confidence: 99%

“…Four articles were peer-reviewed published manuscripts, 21,22,24,26 one was pre-proof,23 and seven were pre-print. [17][18][19][20]25,27,28 Among all, 6 studies were add-on AYUSH interventions studies 17,18,21,[24][25][26] and 6 were standalone interventions. 19,20,22,23,27,28 One study reported with placebo control 22 whereas eleven reported standard of care as a comparator.…”

Section: Figure 1: Prisma Flow Chartmentioning

confidence: 99%

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AYUSH interventions for COVID-19 - a living systematic review and meta-analysis [First report]

Thakar¹,

Panara²,

Goyal³

et al. 2022

Preprint

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BackgroundIn India, alternative and complementary therapies (AYUSH medicines) are utilized in COVID-19 management extensively. This study was planned to assess the prophylactic and therapeutic effectiveness of AYUSH interventions on COVID-19 through a living systematic review and meta-analysis approach.MethodsDifferent databases like Pubmed; the Cochrane central register of controlled trials; WHO COVID-19 database; the central trial registry - India; Digital Helpline for Ayurveda Research Articles and AYUSH research portal, and pre-print repositories were searched with appropriate search strategies from 1st December 2019 to 1st April 2021. Randomized clinical trials, Non-Randomized Studies of Interventions conducted on the AYUSH system of medicine aimed at either prevention or treatment were included. Clinical improvement, WHO ordinal scale, viral clearance, incidences of COVID-19 infection, and mortality will be considered as primary outcomes. Secondary outcomes will be the use of O2 therapy or mechanical ventilator, admission to high dependency unit or emergency unit, duration of hospitalization, the time to symptom resolution, and adverse events. Data will be synthesized, and the risk of bias will be assessed with RevMan 5.4 tool. The risk of bias of included studies was evaluated by RoB-2 and ROBINS-I tools, and the certainty of the evidence ranked through the GRADE approach.ResultsOf 2,977 studies retrieved, only 12 studies were included in the systematic review. In a moderately certain trial on standalone AYUSH versus Standard care, viral clearance was hastened in the standalone AYUSH group. Add-on AYUSH had shortened time to symptom resolution by about two days compared to standard care with moderate certainty. However, Add-on AYUSH intervention may hasten clinical improvements but has little to no effects on viral clearance. AYUSH prophylaxis may reduce the risk of COVID-19 with low certainty.ConclusionRational use of integrated or standalone AYUSH interventions in mild to moderate COVID-19 patients may provide therapeutic benefits. The effect of AYUSH prophylaxis in the reduction of incidence of COVID-19 in high-risk populations is uncertain. The effect estimates may be changed with additional evidence in upcoming updates.

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Section: Quality/risk Of Bias Of Included Studiesmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Figure 1: Prisma Flow Chartmentioning

confidence: 99%

Section: Figure 1: Prisma Flow Chartmentioning

confidence: 99%

Section: Figure 1: Prisma Flow Chartmentioning

confidence: 99%

See 3 more Smart Citations

AYUSH interventions for COVID-19 - a living systematic review and meta-analysis [First report]

Thakar¹,

Panara²,

Goyal³

et al. 2022

Preprint

Self Cite

View full text Add to dashboard Cite

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A prophylactic community-based study to assess the impact of Ayuraksha kit in COVID-19

Mundada,

Makhija,

Sunita

et al. 2022

Journal of Research in Ayurvedic Sciences

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BACKGROUND: The rise in the number of newly reported cases heralds the onset of the third wave of COVID-19 in India, despite the country’s relentless push for COVID-19 vaccination. In such a situation, efforts other than the vaccination, to strengthen the population’s immune system have become critical to keep the overburdened health-care system from being exhausted. Ayuraksha Kit includes four Ayurveda medicines viz., Chyawanprash, Samshamani Vati, Anu Taila and Ayush Kwath choorna. This kit is developed with an aim to enhance the general wellbeing and immunity of apparently healthy individuals. During the COVID-19 pandemic, this trial will investigate the impact of the Ayuraksha Kit as an adjunct to standard preventative measures in safeguarding people living in 12 Indian cities. MATERIALS AND METHODS: A community-based cluster randomized controlled trial will be conducted on 8316 apparently healthy adults. The clusters will be randomly allocated to two groups, intervention and control groups, in a 10:1 ratio. The advice on standard preventive measures along with masks and soaps for hand hygiene will be provided to all the study participants in both groups. Ayuraksha Kit will be given for one month to the 7560 study participants in the intervention group, and the 756 participants in the control group will be only given standard preventive measures. Effect of Ayuraksha Kit on incidence and severity of COVID-19 like symptoms and the psychological distress as an impact of risk of exposure to SARS CoV-2 will be assessed during this study. DISCUSSION AND CONCLUSION: As this study will be conducted in the areas predominantly resided by people belonging to scheduled castes in Indian cities, this cluster-RCT will determine whether the use of Ayuraksha Kit has a prophylactic potential against the incidence or on the severity of disease. TRIAL REGISTRATION: CTRI/2022/02/040156 dated 10th February 2022.

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Guduchi Ghanavati to Improve Immune Status and General Health in the Population at High Risk of COVID-19: Results of An Open-Label Non-Randomized Clinical Trial from India

Cited by 2 publications

References 12 publications

AYUSH interventions for COVID-19 - a living systematic review and meta-analysis [First report]

AYUSH interventions for COVID-19 - a living systematic review and meta-analysis [First report]

A prophylactic community-based study to assess the impact of Ayuraksha kit in COVID-19

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