Safety and Pharmacological Profile of Pancha Lavana Dravagam

Pancha Lavana Dravagam, from Siddha System of Pharmacopoeia is a distillate drug comprising of minerals. It was indicated for Gunmam (Gastritis), Eri gunmam (Dyspepsia), Soolai (Colic), Kalleeral / Maneeral Veekam (Enlargement of Liver or Spleen), Soodhaga vali (Dysmenorrhea), Soodhaga vaayu (Amennorhea). Hence, it is studied for Anti-Ulcer, Hepatoprotectivity and Anti Spasmodic activity in animal models. The review of literature for the ingredients of drug was done in order to reveal the uniqueness of drug. It was carried out in three aspects viz, Siddha aspect (to know the details given in old siddha literatures), Mineralogical aspect (to know about the structure and its mineralogical values) and Chemical aspect (to know its chemical properties and reactivity). After literature review, the drug was exposed to standardization. As a preliminary step, the drug was subjected to Physicochemical and Biochemical analysis, FTIR and Instrumental analysis was done by ICP – OES. After collecting adequate data on standardization of the drug, it was subjected to toxicological evaluation to ensure safety of the drug. It was done by following OECD guidelines 423 (Acute Oral Toxicity) and 407 (Sub-acute Oral Toxicity). The results of the toxicity studies indicated that the drug is nontoxic and it will not produce any toxic signs on human beings on repeated dose for 28 days. After assuring the safety of test drug, pharmacological studies were carried out for Anti-Ulcer activity, Hepatoprotective activity and Anti-Spasmodic activity in animal models to explore its therapeutic efficacy. The results of these study showed that the test drug has potent activity against liver and gastro intestinal disorders. Thus, the drug Pancha Lavana Dravagam has significant medicinal values and it can be a good drug of choice for proceeding with clinical trials in future. CONCLUSION: Pancha Lavana Dravagam is a poly mineral siddha formulation obtained by distillation process as mentioned in the text named Siddha System of Pharmacopeia. The drug was agreeably standardized and characterized as per the AYUSH guidelines mentioned by Pharmacopoeial Labarotary of Indian Medicines. The safety of the drug was ensured by conducting Acute and Sub-acute oral toxicity studies in animal models based on OECD guidelines 423 and 407. Then the drug was evaluated pharmacologically for Anti-Ulcer, Hepatoprotectivity and Anti-Spasmodic activities to ensure the efficacy. Based on the above studies, it is evident that the drug Pancha Lavana Dravagam is safe and therapeutically effective. Further clinical studies can be done to bring it as effective drug for diseases of liver and gastro intestinal tract