Context: Bitter melon (Momoradica charantia) is one of the well-known plants used for lowering blood glucose since antiquity. Aims: To compare the efficacy and safety of PDM011011 capsule (1200 mg/day) with Metformin (1000 mg/day) in a 15 weeks study using mean change in fasting plasma glucose (FPG) and Hb1Ac% in subjects with type 2 diabetes mellitus (T2DM). Settings and
Backgroud. Glycaemic imbalance, especially hypoglycaemia, is one of the greatest risks for patients with type 2 diabetes mellitus (T2DM) during Ramadan fasting. This paper outlines the efficacy and safety of gliclazide extended-release (XR) in Indian patients with T2DM enrolled in the global DIA-RAMADAN study. Methods. Adults (aged ≥ 18 years) with T2DM who chose to fast during Ramadan and received a gliclazidebased regimen once daily for 90 days before Ramadan were included in the study. Baseline and end-of-study visits were conducted 6-8 weeks before and 4-6 weeks after Ramadan, respectively. The primary outcome was the incidence of ≥ 1 symptomatic hypoglycaemic event (HE). Changes in glycated haemoglobin (HbA 1c ), fasting plasma glucose (FPG), and body weight were secondary outcomes. Results. Among 246 Indian patients enrolled in the study, most (78.9%, n = 194) were at moderate/low risk as per the International Diabetes Federation and Diabetes and Ramadan guidelines. Most patients (69.1%) received gliclazide XR as monotherapy, and the rest received gliclazide XR with metformin or other antidiabetic therapy. Significant reductions in HbA 1c (−0.5 ± 0.8%, P < 0.001) and FPG (−21.8 ± 59.4 mg/dL, P < 0.001) levels were observed but the slight reduction in body weight was not statistically significant (−0.3 ± 3.7 kg, P = 0.614) in patients post-Ramadan. Overall, no HE was reported in Indian patients with T2DM during Ramadan fasting. Conclusion. Overall, the effectiveness and safety of gliclazide XR in Indian patients were consistent with that observed in the global cohort. Gliclazide XR significantly reduced HbA1c with no incidence of hypoglycaemic events in Indian patients with type 2 diabetes undergoing Ramadan fast, suggesting that gliclazide
Background: Existing therapeutic measures for swelling, aching and discomfort in the lower limbs, which include compression stockings and leg elevation, are difficult to use and inconvenient. Patch It ® , a proprietary herbomineral patch is an easy-to-use alternative therapy. This trial was conducted to compare it's efficacy against that of a placebo in swollen and aching lower legs and feet. Methods: This randomized, placebo-controlled, double blind, crossover, sequential trial was conducted in the private clinics of physicians. A total of 100 patients (24 men and 76 women), aged 25 to 60 years, with recurring swelling in the feet and (optionally) up to two more related complaints, having an average visual analog score (VAS) of at least 60 (scale 0-100) for each complaint were recruited into the study. Patches (active or placebo) were applied to both soles overnight for 8 weeks: 4 consecutive weeks each with active or placebo in randomized sequence. Outcome measures included the average VAS score (baseline to week 4, and week 5 to week 8), preference for either patch (difference of .5 mm in average VAS score reduction), ankle figureof-eight measures, investigator's global assessment (good, fair, poor), patient's willingness to continue using the patch after the trial (yes, no), and adverse events. Results: Out of 100 patients, 86 completed the trial, while ten were excluded for noncompliance, three withdrew, and one was lost to follow-up. The active placebo boundary of the sequential chart was crossed when 82 patients completed the trial. Active patch was also superior to placebo patch by mean reductions in average VAS scores (13.14 versus 9.6, P = 0.02), mean reduction in figure-of-eight ankle measurements (1.21 cm versus 0.79 cm, P = 0.003), investigator's global assessment (P , 0.01), and by proportion of patients willing to continue using the patch after the trial (P , 0.01). Ten percent of patients experienced localized itching with each patch, but this did not require interruption of treatment. Conclusion: Patch It had greater efficacy than the placebo in alleviating recurring swelling and aching in the legs and feet, and is well tolerated.
Objective: To assess the clinical characteristics, risk factors, and comorbidities associated with type 2 diabetes mellitus (T2DM) in young adult patients. Methods: This is a retrospective, multicentric real-world study that included young adults (18–45 years) with T2DM. Primary information including demographics, medical and family history, biochemical measures (pre-and post-prandial blood glucose levels, glycosylated hemoglobin [HbA1c] and blood pressure, and lipid parameters) smoking and drinking habits were collected retrospectively from the medical records of the respective hospitals/clinics. Data were analyzed using descriptive and appropriate comparative statistics. Results: A total of 22,921 patients from 623 sites were included. The median age was 37.0 years and the majority were men (61.6%). The proportion of patients from the age group >35–≤45 years was 62.7%. Among all patients, 46.9% had only T2DM; however, 53.1% of patients had T2DM with other comorbidities (T2DM with hypertension, dyslipidemia, and both). The majority of patients had elevated body mass index (BMI) (overweight, 46.6%; and obese, 22.9%). Family history of T2DM (68.1%) was most common in overall population. Sedentary lifestyle (63.1%), alcohol consumption (38.9%), and regular smoking (23.1%) were the most common associations in patients with T2DM with dyslipidemia and hypertension. Uncontrolled HbA1c level (≥7%) were observed in 79.2% of patients. The level of HbA1c was significantly increased with the duration of T2DM and sedentary lifestyle ( p < 0.001). Conclusion: Higher BMI, family history of T2DM, sedentary lifestyle, alcohol consumption, and smoking were the most common risk facors, while hypertension and dyslipidemia were the most prevalent comorbidities associated with T2DM in young Indian adults.
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