Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite mica

Introduction: The Bhasmas, herbo-minerals, are reported to produce adverse effects when used clinically. Therefore, the present study aimed to assess the safety of Krishna Vajra Abhraka Bhasma (KVB), through acute and subacute toxicity testing. Materials and Methods: After ethics committee approval,...

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Main Authors: Vijaya Anil Pandit, Sharwan Kumar Singhal, Gourav Bharat Deshmane, Ranjana Ajit Sahasrabuddhe, Manjiri Neelkanth Karandikar, Madhuri Sadashiv Pawar, Vishakha Sumant Kulkarni, Jayshree Shriram Dawane, Asmita Ashish Wele
Format: Article
Language:English
Published: Elsevier 2024-11-01
Series:Journal of Ayurveda and Integrative Medicine
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Online Access:http://www.sciencedirect.com/science/article/pii/S0975947624000950
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author Vijaya Anil Pandit
Sharwan Kumar Singhal
Gourav Bharat Deshmane
Ranjana Ajit Sahasrabuddhe
Manjiri Neelkanth Karandikar
Madhuri Sadashiv Pawar
Vishakha Sumant Kulkarni
Jayshree Shriram Dawane
Asmita Ashish Wele
author_facet Vijaya Anil Pandit
Sharwan Kumar Singhal
Gourav Bharat Deshmane
Ranjana Ajit Sahasrabuddhe
Manjiri Neelkanth Karandikar
Madhuri Sadashiv Pawar
Vishakha Sumant Kulkarni
Jayshree Shriram Dawane
Asmita Ashish Wele
author_sort Vijaya Anil Pandit
collection DOAJ
description Introduction: The Bhasmas, herbo-minerals, are reported to produce adverse effects when used clinically. Therefore, the present study aimed to assess the safety of Krishna Vajra Abhraka Bhasma (KVB), through acute and subacute toxicity testing. Materials and Methods: After ethics committee approval, total 66 Wistar albino rats weighing 180–200 gms were used. Experiments were conducted as per CCSEA guidelines. In acute toxicity study, a single limit dose of 2000 mg/kg of KVB with honey was administered to six female rats. Subacute toxicity studies involved 60 Wistar albino rats of either sex, randomly divided into six groups and received KVB in low (highest clinical dose extrapolated to rats), medium (double the low dose) and high (double the medium dose) dose administered orally for 28 days. Results: No mortality or adverse effects on rat's general behaviour or internal organs was observed in acute toxicity study The results of subacute study indicated no significant differences in body and organ weights, hematological or renal function between control and treated groups. However, mid and high doses of KVB revealed reversible, dose-dependent hepatotoxicity through biochemical and histopathological evaluation, while the satellite high dose group did not exhibit this effect, confirming it as drug-induced hepatotoxicity. Conclusion: The acute toxicity results positioned KVB in class V (safe) of the GHS classification. Subacute toxicity findings suggested that while low therapeutic doses were non-toxic, mid and high doses induced reversible hepatotoxicity, emphasizing the importance of careful dosage considerations and patient monitoring in Ayurvedic practice. The study contributes valuable insights into the safety profile of KVB, addressing concerns for both users and practitioners of Ayurvedic medicine.
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spelling doaj-art-8cad80db5dcf4a3887e6c721671d8e582024-12-23T04:19:01ZengElsevierJournal of Ayurveda and Integrative Medicine0975-94762024-11-01156100980Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite micaVijaya Anil Pandit0Sharwan Kumar Singhal1Gourav Bharat Deshmane2Ranjana Ajit Sahasrabuddhe3Manjiri Neelkanth Karandikar4Madhuri Sadashiv Pawar5Vishakha Sumant Kulkarni6Jayshree Shriram Dawane7Asmita Ashish Wele8Bharati Vidyapeeth (DU) Medical College, Pune, IndiaBharati Vidyapeeth (DU) Poona College of Pharmacy, Pune, IndiaBharati Vidyapeeth (DU) Dental College and Hospital, Pune, IndiaBharati Vidyapeeth (DU) Medical College, Pune, IndiaBharati Vidyapeeth (DU) Medical College, Pune, IndiaBharati Vidyapeeth (DU) College of Ayurveda, Pune, IndiaMNR College of Pharmacy, Hyderabad, IndiaBharati Vidyapeeth (DU) Medical College, Pune, IndiaDepartment of Rasashastra & Bhaishajyakalpana, Dr. D.Y. Patil College of Ayurved & Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pune- 411018, India; Corresponding author.Introduction: The Bhasmas, herbo-minerals, are reported to produce adverse effects when used clinically. Therefore, the present study aimed to assess the safety of Krishna Vajra Abhraka Bhasma (KVB), through acute and subacute toxicity testing. Materials and Methods: After ethics committee approval, total 66 Wistar albino rats weighing 180–200 gms were used. Experiments were conducted as per CCSEA guidelines. In acute toxicity study, a single limit dose of 2000 mg/kg of KVB with honey was administered to six female rats. Subacute toxicity studies involved 60 Wistar albino rats of either sex, randomly divided into six groups and received KVB in low (highest clinical dose extrapolated to rats), medium (double the low dose) and high (double the medium dose) dose administered orally for 28 days. Results: No mortality or adverse effects on rat's general behaviour or internal organs was observed in acute toxicity study The results of subacute study indicated no significant differences in body and organ weights, hematological or renal function between control and treated groups. However, mid and high doses of KVB revealed reversible, dose-dependent hepatotoxicity through biochemical and histopathological evaluation, while the satellite high dose group did not exhibit this effect, confirming it as drug-induced hepatotoxicity. Conclusion: The acute toxicity results positioned KVB in class V (safe) of the GHS classification. Subacute toxicity findings suggested that while low therapeutic doses were non-toxic, mid and high doses induced reversible hepatotoxicity, emphasizing the importance of careful dosage considerations and patient monitoring in Ayurvedic practice. The study contributes valuable insights into the safety profile of KVB, addressing concerns for both users and practitioners of Ayurvedic medicine.http://www.sciencedirect.com/science/article/pii/S0975947624000950Organ toxicityHerbo-mineral agentsKrishna vajra abhraka bhasmaLiver toxicityKidney function
spellingShingle Vijaya Anil Pandit
Sharwan Kumar Singhal
Gourav Bharat Deshmane
Ranjana Ajit Sahasrabuddhe
Manjiri Neelkanth Karandikar
Madhuri Sadashiv Pawar
Vishakha Sumant Kulkarni
Jayshree Shriram Dawane
Asmita Ashish Wele
Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite mica
Journal of Ayurveda and Integrative Medicine
Organ toxicity
Herbo-mineral agents
Krishna vajra abhraka bhasma
Liver toxicity
Kidney function
title Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite mica
title_full Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite mica
title_fullStr Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite mica
title_full_unstemmed Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite mica
title_short Toxicity profile of standardized Krishna Vajra Abhraka bhasma made from biotite mica
title_sort toxicity profile of standardized krishna vajra abhraka bhasma made from biotite mica
topic Organ toxicity
Herbo-mineral agents
Krishna vajra abhraka bhasma
Liver toxicity
Kidney function
url http://www.sciencedirect.com/science/article/pii/S0975947624000950
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