Pre clinical and clinical study on Swasa Kasam and the drug of choice is Thuthuvalayathy Chooranam

The aim of the study was to evaluate the therapeutic efficacy of the drug Thuthuvalayathy chooranam (internal medicine) in Swasa kasam. • Before initiating the clinical trial, approval was got from the Institutional Animal Ethical Committee (1248/ac/09/CPCSEA/4/04/2011 – 20/12/2011) and Institutional Ethical Committee (NIS/IEC/2011/3/04 – 24/12/2011) for conducting the pre clinical studies and clinical studies respectively by submitting the well defined protocol and proforma. • The raw drugs were authenticated by the concerned department and the trial drug was prepared by the investigator in the Gunapadam lab of National Institute of Siddha as per the Standard Operating Procedure mentioned in the protocol. • The medicine was then subjected to pre clinical toxicity studies (Acute and sub acute toxicity studies) as per the protocol and the safety of the drug was ensured. • From the Acute oral toxicity study, the trial drug was found to be safe even at higher dose level of 0.027gm/kg/bw. • From the sub acute toxicity study the trial drug at the dose of 0.27gm/kg/bw (10X) did not exhibit any mortality in rats. • The qualitative and quantitative bio chemical studies were done at the bio chemistry lab of National Institute of Siddha and IIT Chennai respectively. • For the clinical study, 40 cases were selected based on the inclusion and exclusion criteria. Out of this, 30 cases were treated in OPD and 10 cases were treated in IPD of Ayothidoss pandithar hospital of NIS, Chennai. • A day before starting the trial drug treatment, purgation was given to correct the elevated mukkutram. • The clinical trial was conducted in 40 patients of Swasa kasam with the trial drug thuthuvalayathy chooranam(internal medicine) at the dose of 1.5gm twice a day with adjuvant of honey .During the study period, there were no adverse reactions. • The trial drugs were found to play the major role to correct the deranged three humours, thereby correcting Pranan, Abanan, Udhanan, Kirugaran, Devathathan Vayus, Pitham such as Anal Pitham and the vitiated kabam is restored to the normal. • Blood and urine Investigations were carried out before and after treatment and data were recorded in the proforma. • Radiological investigations (Chest X-ray PA view) and ECG were also done before treatment. • Clinical assessments Progress were done once in 7 days for OPD patients and daily for IPD patients. • As per objective parameters (PEFR) Out of 40 cases, 72.5% of cases had clinically good improvement, 22.5% of cases had clinically moderate improvement and 5% of cases had clinically mild improvement. • Out of 40 cases, Clinical results were found to be Good in 87.5% of cases, Moderate results were found in 10% of cases and Mild results were found in 2.5% of cases Statistical analysis: PEFR, Esinophil,ESR for ½ hr and 1 hrs before treatment and after treatment is statistically significant (p