Details of AYUSH-64
|Name of trial
|A Randomized, Open Label, Parallel Efficacy, Active Control, Multi-Centre Exploratory Drug Trial to Evaluate Efficacy and Safety of Ayurvedic formulation-4 (AYUSH-64) as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients
|CSIR lab/s involved
|Clinical Trial Site/s
|Type of Drug
|AYUSH-64: 500 mg tablet, 2 tablets bid (twice daily)
|Mechanism of Action & Scientific rationale for Covid-19
AYUSH–64 is a poly-herbal formulation developed by Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Govt. of India that targets VKJ and has also been shown to be useful in the management of malaria. The AYUSH-64 has been used in more than 13,000 patients during the malaria epidemic of 1984. The advisory by the AYUSH Ministry for COVID-19 has recommended AYUSH–64 for symptomatic management. The formulation consists of Saptaparna (Alstonia scholaris R. Br.) bark aqueous extract 100 mg, Katuki (Picrorhiza kurroa Royle ex. Benth) root extract 100 mg, Kiratatikta (Swertia chirata Pexbex. Karst) whole-plant extract 100 mg. and Kuberaksha (Caesalpinia crista L.) seed powder 200 mg in each tablet.
The experimental studies of AYUSH-64 have shown that it was safe and non-toxic in the dose of 500 mg/kg of body weight for 12 weeks. It is found to be effective in fevers of unknown etiology, filarial lymphangitis and derangement of liver function besides its anti -malarial activity. Various Ayurveda classics describe activities and properties of the ingredients of AYUSH-64 in respiratory diseases and also acute infectious diseases with pulmonary complications. The ingredients are effective in diseases of Kapha, and Vata, improve Agni, digest Ama, strengthen tissues, relieve symptoms and restore health.
Based on the clinical experience of physicians who had successfully used AYUSH-64 to treat Influenza like Illness (ILI), a pilot study was recently carried out by CCRAS. In this clinical observational study, 28 out of 30 participants recovered satisfactorily and did not require any other drug. It is against the latter experience that it was decided to evaluate AYUSH-64 in the treatment of COVID-19. Studies on the ingredients of AYUSH-64 has shown anti-inflammatory and immunomodulatory activities. In animal study, the alkaloids from Saptaparna inhibited the production of inflammatory cytokines TNF-α and IL-8 in the broncho-alveolar lavage fluid from the lung. In an in-vitro molecular study, whole plant extracts of Swertia chirata inhibited the expression of viral protein (Vpr) of Herpes Simplex Virus Type 1 in a cell culture (Hela cells harbouring the TREX plasmid encoding full-length Vpr).
|Combinations therapy or monotherapy
|As Adjunct Treatment to Standard of Care
Health Condition / Problems Studied
Click here for End points (primary and secondary)
|Status of the CSIR trial
|Name & details of Clinical PI/s
|Datta Meghe Institute of Medical Sciences, Nagpur (Maharashtra)
|Dr. Himanshu Reddy
|Department of Medicine, King George Medical University, Lucknow-226003