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REVIEW ARTICLE
Year : 2022  |  Volume : 7  |  Issue : 4  |  Page : 221-228

Safety profile of Ayurveda Rasoushadhi: An appraisal of technical reports on quality and safety of selected Rasakalpa—Metal and mineral-based Ayurvedic formulations


Central Council for Research in Ayurvedic Sciences (CCRAS), Janakpuri, New Delhi, India

Correspondence Address:
Dr. Bidhan Mahajon
Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences (CCRAS), Janakpuri, New Delhi 110058
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jdras.jdras_73_22

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To a large extent, the safety of Rasoushadhi (metal and mineral-based formulations) is evident by its long history of clinical use. However, certain published literature generated misconceptions regarding their quality and safety across the globe. Thus, to protect the massive trust in Ayurveda, a multidisciplinary study was conducted by Central Council for Research in Ayurvedic Sciences for the assessment of the quality and safety of eight important Rasoushadhi, viz., Arogyavardhini vati (Ayurvedic Formulary of India [AFI]-I, 20:4), Mahayogaraja guggulu (AFI-I, 5:6), Vasantakusumakar rasa (AFI-I, 20:42), Mahalaxmivilas rasa (AFI-I, 20:27), Rasamanikya (AFI-I, 20:33), Makaradhwaja (AFI-I, 15:2), Kajjaliyoga (AFI-III, 15:15), and Rasasindur (AFI-I, 15:6) under Golden Triangle Partnership (GTP) scheme. The present article is an appraisal of the published Technical Reports (Volumes 1 and 2) of GTP that highlights the collective safety outcome of these selected Rasoushadhi. Study investigators prepared these Rasoushadhi in a Good Manufacturing Practice (GMP)-certified pharmacy, and they performed repeated-dose oral toxicity studies per Organization for Economic Co-operation and Development-408 guidelines in Wistar albino rats. All the Rasoushadhi were orally administered at different dose levels for 90 days. Periodically, observations were done by the investigators for clinical signs of toxicity, mortality, morbidity, body weight changes, and feed consumption. After 90 days, they performed hematology, biochemistry, electrolytes, relative organ weight, and histological examinations. The study concluded that there were no significant differences in the observed parameters between the control and Rasoushadhi-treated rats. In histological examinations, also they found no toxicologically significant abnormalities related to any Rasoushadhi treatment. Based on the result, the investigators concluded that all the formulations were safe up to the tested high dose levels.


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