Toxicity tests were carried out in mice using five times the human dose (60 mg/dose) orally following the method of IP-85 (Chloramphenicol Palmitale Drug and Cosmetic Act, 1940). None of the mice showed undue or abnormal toxicity even after 72 hrs. (Table 9). Shelf life of polypeptide-k was also determined which came to be two years (Table 10).

Clinical trials were carried out in thousands of confirmed diabetic patients from whom only 100 diabetic patients were selected in this study who were on test trials for a long period  (Table 11). Each formulation (60 mg polypeptide-k + 50 mg potato starch / tablet) was administered through tongue four times per day (each dose of one tablet) 10 min. before every meal. Inhaling of the Polypeptide-k was also very effective in lowering the blood sugar level. No side effect has been reported except in rare cases where the patient was allergic to bitter gourd vegetable also allergic to polypeptide-k. Small Scale Industry has been installed in India.

A Juvenile diabetic patient (blood sugar level 550mg/dl) working in the unit for the last 6 years is now having considerably reduced blood sugar level (128 mg/dl as PP and fasting as 90 mg/dl). He has been feeling normal and the dose of Polypeptide-k is reduced from four to two.

Patents of polypeptide-k have been obtained from India ⁷, South Africa ⁸, U.S.A. ⁹, Australia ¹⁰, China ¹¹, Japan ¹², Canada ¹⁴ , and Indonesia ¹⁵ after getting search report from PCT ¹⁶. and European Union ¹⁷ . The Patent from Malaysia is awaited. The product has been launched in China and Malaysia and is being formulated and sold in Japan as well. The product is registered for sale in some parts of South East Asia. The polypeptide-k is also being sold world wide on Internet. A feedback from some of the selective patients is also given (Table 12).Toxicity tests were carried out in mice using five times the human dose (60 mg/dose) orally following the method of IP-85 (Chloramphenicol Palmitale Drug and Cosmetic Act, 1940). None of the mice showed undue or abnormal toxicity even after 72 hrs. (Table 9). Shelf life of polypeptide-k was also determined which came to be two years (Table 10).

Clinical trials were carried out in thousands of confirmed diabetic patients from whom only 100 diabetic patients were selected in this study who were on test trials for a long period  (Table 11). Each formulation (60 mg polypeptide-k + 50 mg potato starch / tablet) was administered through tongue four times per day (each dose of one tablet) 10 min. before every meal. Inhaling of the Polypeptide-k was also very effective in lowering the blood sugar level. No side effect has been reported except in rare cases where the patient was allergic to bitter gourd vegetable also allergic to polypeptide-k. Small Scale Industry has been installed in India.

A Juvenile diabetic patient (blood sugar level 550mg/dl) working in the unit for the last 6 years is now having considerably reduced blood sugar level (128 mg/dl as PP and fasting as 90 mg/dl). He has been feeling normal and the dose of Polypeptide-k is reduced from four to two.

Patents of polypeptide-k have been obtained from India ⁷, South Africa ⁸, U.S.A. ⁹, Australia ¹⁰, China ¹¹, Japan ¹², Canada ¹⁴, and Indonesia ¹⁵ after getting search report from PCT ¹⁶. and European Union ¹⁷ . The Patent from Malaysia is awaited. The product has been launched in China and Malaysia and is being formulated and sold in Japan as well. The product is registered for sale in some parts of South East Asia. The polypeptide-k is also being sold world wide on Internet. A feedback from some of the selective patients is also given (Table 12).