Startseite Acute and sub acute toxicity of Amirdha Gandhi Kukkil Vallathy an effective Siddha herbo mineral formulation used in the treatment of rheumatoid arthritis in wistar albino rat model
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Acute and sub acute toxicity of Amirdha Gandhi Kukkil Vallathy an effective Siddha herbo mineral formulation used in the treatment of rheumatoid arthritis in wistar albino rat model

  • Juliet Lawrence EMAIL logo , Sugin Lal Jabaris S , Ramadevi Bhogireddy , Kanakavalli Kadarkarai , Kabilan Natarajan , Christian Gnanaraj Jhonson , Ganesan Rathinam und Sivakkumar Sandhirappan
Veröffentlicht/Copyright: 12. Juni 2023

Abstract

Objectives

Amirdha Gandhi Kukkil Vallathy (AGKV) is a herbo mineral Siddha formulation which has Sulphur, Kukkil, Seendhil and Serankottai as major ingredients and it is indicated for 80 types of Vatham diseases. Uthiravatha suronitham is one among the vatham diseases and it’s clinical symptoms are correlated with Rheumatoid arthritis (RA). Since AGKV is a promising drug for RA, the safety of this drug has been validated by performing the acute and 28 days repeated oral dose toxicity study following the OECD guidelines 423 and 407.

Methods

The acute toxicity study has been performed by administering orally with a single dose of 300 and 2000 mg/kg body weight in rat models and the animals were observed for 14 consecutive days. Gross pathology was observed and animals were sacrificed at the end of the study. In 28 days repeated oral toxicity study, limit test has been carried out with a dose of 1,000 mg/kg body weight.

Results

No significant abnormality has been observed in the body weight, organ weight, biochemical parameters and histopathology studies. It has been revealed that this drug is safe upto 2000 mg/kg body weight in single dose study and 1,000 mg is a safer dose in the 28 days repeated oral toxicity study.

Conclusions

The results of acute and 28 days repeated oral toxicity studies revealed no adverse effects in animals and hence this drug AGKV is safe and can be administered in human.


Corresponding author: Dr. Juliet Lawrence, MD (S), Research Officer (S), Department of Clinical Research, Siddha Central Research Institute, Central Council for Research in Siddha, Ministry of Ayush, Government of India, Arumbakkam, Chennai, 106, Tamil Nadu, India, E-mail:

Acknowledgments

Authors thank all the staff of Department of Pharmacology and Department of Bio chemistry for supporting the research during the whole study as per protocol.

  1. Research funding: None declared (Part time PhD–study).

  2. Author contributions: LJ – research work, conceptualized, drafted the manuscript, RB-assisting the study SSL – reviewed the pharmacological part SSK-assisted in writing the manuscript, KK, NK and CJC-Supervised the study, RG-analysis of blood investigations and report. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: The Institutional Animal Ethical Committee approved the study. The Doctoral Advisory Committee supervised the study.

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Received: 2023-01-09
Accepted: 2023-05-19
Published Online: 2023-06-12

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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