An Open Label Single Arm Clinical Study on the Combined Effectiveness of Ayaskriti and Navaka Guggulu in the Management of Madhumeha (Diabetes Mellitus Type 2)

Madhumeha is considered as one of the ashtamahagad as caused by the involvement of tridosha and dashadushyas. As Madhumeha is krichrasadya or yapya, a good control and effective management is ultimate aim to reduce the risk of the development of further complications. It is quite difficult to formulate a single drug effective on all clinical manifestations of Madhumeha.

With this background there is a need for drugs from herbal source which is effective, with least adverse effects and palatable so that patient can use the drug lifelong to control Madhumeha. The study focus on assessing the combined effect of Ayuskriti and Navaka Guggulu, a preparation mentioned for the management of Madhumeha. The combined effect of these drugs and properties like kledahara, medohara, dravashoshana, ushnavirya, and katuvipakan would be beneficial in the management of Madhumeha. Ayaskritiis an arishta yoga which has the combination of Asanadigana having Kashaya-Tiktapradhanarasa, katuvipaka, and ushnavirya. Similarly Navaka Guggulu contains triyushana and triphala which is deepaniya and pachaniya, laghu and rookshan and guggulu with medohara properti. The combination of these drugs will be helpful in the Dhosaprathyanika and Vyadiprathyanika Chikitsa of Madhumeha. And also after thorough review of research in Ayurveda other thesis data base did not yield any result in relation to the combination of Ayaskriti and Navaka Guggulu.

 In the preset study, open label single arm clinical trial at OPD or IPD basis would be done with pre and post-test design for the included 30 patients. Pre diagnosed and freshly diagnosed patients will be taken.  Than  Ayaskriti 20 ml and Navaka Gugguku 500 mg thrice daily in the morning and night will be administered after food with ushnodaka as anupana for the 30 days. After the 30 days again the blood investigations will be done to rule out the effect of drugs administered. Hence the entire treatment will be completed in 30  days.

The patient will be assessed on the 1st day and 30th day with investigations like FBS, PPBS, Blood routine, lipid profile and urine routine. Assessment would be done based on subjective and objective parameters and would also be monitored for Adverse Drug Reactions or Adverse Drug Effects or other concurrent illness.

The collected data will be tabulated and analyzed using Statistical Package for Social Sciences (SPSS) version 20.Statistical tests like paired t test, repeated measure anova will be done.