Safety and efficacy of an oral insulin (Capsulin) in patients with early-stage type 2 diabetes: A dose-ranging phase 2b study.

AIM: To compare the pharmacodynamic properties of different doses of regular human insulin administered in capsule form twice daily in a randomised twelve-week open-label study. METHODS: A total of 100 individuals (48 males, 52 females) with type 2 diabetes on metformin completed the study according to the protocol. The mean (SD) age was 48.5 (6.7) years, body mass index 25.7 (2.8) kg/m2 and HbA1c 8.10% (0.65%). Subjects randomized upon admission were assigned to one of three groups receiving formulated regular insulin at dose levels of 75 iu BD, 150 iu insulin BD, or 300 iu BD, all in enteric-coated capsules. The primary and secondary endpoints were change from baseline in HbA1c and fasting plasma glucose (FPG), respectively. RESULTS: The study met its primary clinical endpoint of a decrease in HbA1c of 0.5% or higher (least square mean decrease 0.52%; P = .004, median decrease 0.6%) in the dose group receiving 150 iu BD. In a subset of this population, with starting HbA1c values of 9% to 9.5%, an average decrease of 1.575% was observed. In the total population, least square mean decreases in HbA1c for the 75 and 300 iu BD groups were -0.11% and -0.42%, respectively. Mean change in FPG in the 150 iu BD dose group was -18.8 mg/dl (P = .017) and -14.8 and -2.7 mg/dl for the 75 and 300 iu BD groups, respectively. A decrease of 20% for triglycerides (-40 mg/dl) was observed in the 150 iu BD dose group. No significant increases in body weight were observed, and significant decreases in systolic blood pressure were seen in all groups. No serious treatment-related adverse events were recorded, and no incidence of hypoglycaemia was reported throughout the entire 12-week study period. CONCLUSIONS: Capsulin oral insulin administered twice per day at a dose of 150 iu per capsule is safe, with no confirmed treatment-linked hypoglycaemic events, and results in significant decreases from baseline in HbA1c, FPG and triglycerides.

A pilot study on clinical efficacy of Agnikarma and Pathyadi decoction (an Ayurvedic formulation) in the management of Ardhavabhedaka (migraine).

INTRODUCTION: Ardhavabhedaka described under Shiroroga (disease of the head in Ayurveda) occurs due to vitiation of Tridosha (all of three biological humors). The signs and symptoms of migraine can be correlated with Ardhavabhedaka. Looking to the agony caused during acute episode of migraine and unavailability of specific management and only symptomatic management in conventional medicine this study was conducted. Agnikarma is indicated in severe pain and Pathyadi decoction is indicated in the management of Shiroroga. AIM AND OBJECTIVE: The aim of this study was to evaluate the efficacy of Agnikarma and Pathyadi decoction in the management of Ardhavabhedaka (migraine). MATERIALS AND METHODS: A total of 15 patients were selected from outpatient department of Ayurveda College. Agnikarma was done on affected temporal side of face, dot type for 1 time, once in a week followed by application of honey-Ghee. Along with this, Pathyadi decoction 40 ml twice a day for 30 days was also given. RESULTS: Statistically highly significant relief (P < 0.001) was noted in headache, photophobia and phonophobia and statistically significant (P < 0.05) relief was noted in vomiting, nausea and vertigo. CONCLUSION: Agnikarma along with Pathyadi decoction can be considered as an effective line of treatment to manage Ardhavabhedaka (migraine).

Role of Pradhamana Nasya and Trayodashanga Kwatha in the management of Dushta Pratishyaya with special reference to chronic sinusitis.

Dushta Pratishyaya is the chronic stage of Pratishyaya, which occurs due to neglect or improper management of the disease Pratishyaya. In modern science, chronic sinusitis can be correlated with Dushta Pratishyaya on the basis of the signs, symptoms, complications, and prognosis. Changing lifestyles, rapid urbanization, and the increase in cases of antibiotic resistance are responsible for the rise in the prevalence of sinusitis. In the present clinical study, 37 patients were registered and were randomly divided into three groups: A, B, and C; of the 37 patients, 31 completed the full course of treatment. In group A, Trayodashanga Kwatha with Madhu was given orally; in group B, Pradhamana Nasya with Trikatu + Triphala Churna was administered; and in group C (combined group), Pradhamana Nasya was administered initially, followed by oral Trayodashanga Kwatha with Madhu. In group A, complete relief was observed in 10% of the patients; in group B, marked improvement was observed in 81.82% of patients; and in group C, marked relief was observed in 60% of patients. In comparison to other groups (Group A and Group B), Group C showed percentage wise better results in most of the symptoms.