A Dose related ADR of a Siddha Drug Karpoora Chindhamani Mathirai (KCM)

Introduction: Karpoora Chindhamani Mathirai, a classical Siddha herbo- mineral formulation is sourced from the text Anuboga Vaidhya Navaneedham Part 4. It is indicated for all types of fever, vatha diseases, keel vayu, mudakku vayu (Rheumatoid arthritis). Siddha literature stay alive to Pharmacovigilance. Aim and objective: Primary objective is to find out the therapeutic efficacy of KCM on Uthiravatha Suronitham (Rheumatoid arthritis). The secondary objective is to study its safety aspects. Materials and Methods: 40 patients (20 inpatients and 20 out patients) from the Sirappu Maruthuvam Department of National Institute of Siddha were included in the open clinical trial. They were prescribed KCM – 60mg twice daily for 40 days. The challenges faced were reported to the research committee of National Institute of Siddha. Results: The drug Karpoora Chindhamani Mathirai administered to Uthiravatha Suronitham patients resulted in reduction of joint swelling, pain and stiffness. Vomiting and nausea are the adverse drug reactions noted which were reduced on reducing the drug dosage. 5 patients complained of nausea, 10 had diarrhea, 4 had vomiting. The medicine was stopped and the dosage reduced in keeping with the patient’s condition. Previous studies have detailed about the purgative nature of croton oil in croton seeds. Here also the symptoms reported might be due to Croton tiglium seeds.Conclusion: The Adverse Drug Reaction (ADR) reported cannot to be attributed to a single compound as this is a compound formulation. A trial for longer duration is necessary to study the type a – acute/ augmented-dose related ADR in near future.