Preclinical and Clinical study of siddha drugs Kukkil Chooranam (Internal) and Thuvara Ennai (External) in the Treatment of Pun (Naalavibatha Pun-Varicose Ulcer)

The disease Naalavibatha pun was taken for the clinical study with Kukkil Chooranam as internal medicine and Thuvaraennai as external application. For the clinical study, 40 cases were selected based on the approved protocol. This study has been approved by IEC of NIS [Date of IEC Approval& its number: NIS/IEC/9-2014-15/14-26.08.2015]. Animal studies were carried out after obtaining approval from the Institutional Animal Ethical Committee (IAEC) and the trial was registered in Clinical Trial Registry of India (CTRI/2017/05/008584). Hence the study is safely executed on patients and there was no adverse drug reactions noted during the study period. The toxicological evaluations were conducted as per WHO guidelines for safety evaluation of Kukkil Chooranam. In long term toxicity study, no signs of toxicity and mortality were observed throughout the study period up to the dose of 2000mg/kg body weight. Thus, the LD50 value of Kukkil Chooranam was found to be greater than 2000mg/kg body weight. In Long term toxicity study, there were no significant changes in behavioral signs, food intake, water intake, Lipid Profile, Renal parameters hematological parameters, and Hepatic parameters. The liver function test conducted at the end of the study, test groups (Low, Mid, High dose) revealed no significant changes in level of liver parameters, when compared with control group animals. In organs of Control group, no abnormality was detected. The normal histological structure present in test group of animals. Out of the 40 cases, 10 cases were treated in IPD and remaining 30 cases were treated in OPD of Ayothidoss Pandithar Hospital of National Institute of Siddha, Chennai-47. The detailed study on Naalavibatha pun with reference to its aetiology, pathogenesis, investigations, clinical features, diagnosis and treatment with trial drugs were done. The results were observed by VCSS score. Among the 40 cases treated, 62.5% cases had shown Good improvement, 20% cases had shown Moderate improvement and 17.5% had shown Mild improvement. CONCLUSION: The present clinical study confirms the efficacy of the trial drugs Kukkil chooranam (Internally) and Thuvara Ennai (Externally). It was found to be good resulting on Naalavibatha pun patients in reducing clinical symptoms like ulcer, itching, oozing, pain and oedema. The Short term and Long term toxicitystudiesdid not show any toxic effects in the animal. The quantitative outcome of VCSS score shows there is significant reduction between before and after treatment. The qualitative outcome shows there is 62.5% of cases had shown good improvement, 20% of cases had shown moderate improvement and remaining 17.5% of cases had shown mild improvement. The clinical trial conducted in selected patients was satisfactory and the results were encouraging. However a study with large number of patients is required to fine out the ideal dose response. The cost of the trail medicines are Low. These drugs are easily available and the dosage is also convenient. These drugs may be taken up for further exploratory randomised clinical trials to confirm the efficacy