Pre Clinical and Clinical study on Mathumegam

The aim of the study was to evaluate the safty and efficacy of the drug Atthippattaiyathi kasayam in the treatment of Mathumegam. • Before initiating the clinical trial, approval was got from the Institutional Animal Ethical Committee (IAEC: 1248/ac/09/CPCSEA/4-07/2011 - Dt. 20.12.2011) and Institutional Ethical Committee (IEC: NIS/IEC/2011/3/07 - Dt. 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 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 toxicity studies (Acute and long term toxicity studies) as per the protocol and the safety of the drug was ensured. • The qualitative and quantitative bio chemical studies were done at the biochemistry lab of National Institute of Siddha. • SEM analysis and trace metals detection were done at Sophisticated Analytical Instrument Facility, IIT, Chennai. • The Biochemical analysis of the trial drug was done in Biochemistry laboratory National Institute of Siddha. Biochemical analysis showed the presence of inevitable constituents like Calcium, Iron, Sulphate. • Oral toxicity studies conducted ensured the safety usage of the drug to animals up to a maximum dose of 270 mg/animal for mice and 2700 mg/animal for wister rat. • Histopathological studies was done in pathology lab, Vels University, it shows that there is no abnormalities in the studies. • Among the 60 cases screened at the OPD of Branch-I, Ayothidoss Pandithar Hospital, NIS, 40 cases were recruited for the trial as per the inclusion and exclusion criteria of the Protocol. • Clinical diagnosis of Mathumegam was made by Siddha and Modern methodology. • Before inducement into the trial informed consent was obtained from the patients. • Out of the 40 cases 30 cases were treated in OPD and 10 cases in IPD in Branch-I. • The clinical trial was conducted with the trial medicine Atthippattaiyathi kasayam 5g t.i.d for a period of 40 days, referred under the Siddha literature Yoogi Vaithiya Chinthamani. • Diet restriction was strictly followed during the period of drug administration as per noted in the form IV D (Dietary advice form). • Required lab investigations were carried out before and after the treatment and the concerned data was recorded in the proforma. • Clinical assessment was done daily in all the IP patients and in OP patients it was assessed once in 10 days. • During the study period, there was no event of any adverse reactions owing to the drug or disease. • The clinical and labarotary Obserevation in the Mathumegam patient treated with the trial drug Atthippattaiyathi kasayam showed significant control in their blood glucose level and upgrading with in general health. • Statistical analysis showed significant difference between before and after treatment in the level of blood sugar at Fasting and Postprandial [P < 0.0001]. • In these studies out of 40 cases, 25 cases (62.5%) had good clinical improvement, 6 cases (15%) had moderate and 9 cases (22.5%) had poor improvement. CONCLUSION: The safety studies (the acute toxicity and long term toxicity) studies conducted revealed that the trial drug was safe even at higher dosage of 270 mg/animal for mice and 2700 mg/animal for wister rat. There were no abnormalities found in histopathological examination. Hence it can be reasonably assumed that the drug is safe for human. • Clinical study revealed that the trial drug posses’ good clinical improvement in 25 (62.5%) cases, 6 (15%) cases had moderate results and 9 (22.5%) cases had poor results. • The clinical and labarotary Obserevation in the Mathumegam patient treated with the trial drug Atthippattaiyathi kasayam showed significant control in their blood glucose level and upgrading with in general health. • It is undoubtedly marked that the Medicine used in the siddha system do not have any harmful side effects. • Because of the hopeful results clinically, the study may be undertaken with the same drug for a prolonged period of time in more number of cases and it may throw new lights in the management of Mathumegam