A clinical study to evaluate the efficacy of Herbal Formulation for Obesity (HFO-02) in overweight individuals.

BACKGROUND: Ayurveda, the Indian system of medicine offers many herbs and formulations for management of obesity. Baidyanath Bhawan Pvt. Ltd has designed a formulation, HFO-02, based on Ayurvedic literature. OBJECTIVE: To evaluate the efficacy of Herbal Formulation for Obesity (HFO-02) in overweight individuals. MATERIALS & METHODS: With approval from the Institutional Ethics Committee, a proof of concept study was carried out in overweight individuals (Body Mass Index, BMI ≥25.0 and ≤ 30.0 kg/m2), devoid of any endocrinological disorders. Tablet HFO-02 (500 mg) was administered to these individuals twice daily for 90 days, during which they were called at study site fortnightly. After stopping the treatment, they were further followed up for 30 days off-medication and the last follow up was scheduled on day 120. Anthropometric parameters were assessed at every visit, while biochemical parameters viz. lipid profile, blood sugar & insulin levels (both fasting and post prandial), C- reactive protein and adipocytokines (leptin & adiponectin) were estimated monthly. RESULTS: Of the 18 participants recruited in the study; 14 completed the study. HFO-02 did not show reduction in weight, however a significant decrease in the body circumference and skin fold was demonstrated. This decrease was maintained till day 120. The levels of all biochemical parameters were maintained and no adverse events were reported throughout the study. CONCLUSION: Tablet HFO-02 reduced body circumferences and skinfold thickness indicating its potential for obesity management. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2016/07/007067.

Evaluation of the efficacy and safety of Capsule Longvida® Optimized Curcumin (solid lipid curcumin particles) in knee osteoarthritis: a pilot clinical study.

Purpose: Osteoarthritis is the single most common cause of disability in older adults with an estimated 10% to 15% prevalence in individuals above 60 years. The contemporary medications include nonsteroidal anti-inflammatory drugs acetaminophen, cyclooxygenase-2 inhibitors, and surgical interventions. In view of safety issues regarding their longterm use, necessitating search for effective and safe alternatives, we evaluated Capsule Longvida® Optimized Curcumin prepared using solid lipid curcumin particles (SLCP) technology in patients with knee osteoarthritis. Patients and methods: Eligible patients fulfilling American College of Rheumatology Criteria were randomized to SLCP group (400 mg twice daily delivering 80 mg of curcumin per capsule) or Ibuprofen with placebo group (400 mg each once daily) for 90 days. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Visual Analog Scale (VAS) were used for clinical assessment of knee pain and function. Degree of knee flexion and swelling were also noted. Blood biochemistry included hemogram, blood urea, creatinine, Random blood sugar and inflammatory markers viz. PGE2, TNF α, IL6, IL1ß and LTB4 while urine examination included degenerative marker CTX II. The parametric data was analyzed using unpaired t test while non-parametric data was analyzed using Friedman's test or Mann Whitney t test as applicable. A level of p<0.05 was considered as statistically significant. Results: Out of 50 recruitments, 25 from the Ibuprofen group and 17 from the SLCP group completed the study with significant improvements in VAS and WOMAC scores indicating comparable efficacy of SLCP in alleviating pain with Ibuprofen. None of the markers displayed significant changes. Except one withdrawal in the study group due to rash and itching, the study drug was found safe. Conclusions: SLCP in a dose of 160 mg daily was found to be effective and safe in alleviating symptoms in patients suffering from knee osteoarthritis when administered for 90 days.

Adipocytokines and anthropometric measures in type 2 diabetics.

AIM: Type 2 diabetes mellitus has assumed pandemic proportions worldwide. Aggressive management of hyperglycemia in diabetics is a primary goal of treatment. We have previously reported favorable effects of oral hypoglycemic agents on adipocytokines. Aim of the present study was to investigate the relationship of adipocytokines with anthropometric measures and biochemical parameters in type 2 diabetics. METHODS: Clinically diagnosed type 2 diabetics and age, gender matched healthy volunteers were recruited for study. Anthropometric measurements like height, weight, waist-circumference, hip-circumference were recorded and BMI, waist-hip ratio were calculated. Fasting blood samples were collected from participants and sera were analyzed for glucose, glycated haemoglobin, total cholesterol, SGOT, SGPT, insulin, adiponectin and leptin. Correlation of adipocytokines with anthropometric and biochemical parameters was assessed in healthy and diabetic individuals. RESULTS: BMI and WHR in diabetics were significantly higher than healthy population. BMI did not show significant association with adipocytokines. Diabetic males with WHR≥0.9 showed negative association with adiponectin and positive association with leptin. WC did not show significant association with adipocytokines in males. Irrespective of WC, healthy females exhibited positive association with leptin. Diabetic females with WC≥88cm showed leptin to be positively associated with WC. Such association of adipocytokines with WHR was not detected in females. CONCLUSIONS: Body fat distribution can be considered as a parameter in assessing adipokine imbalance. Central adiposity is a better measure of adipokine imbalance than BMI. Abdominal obesity in diabetics correlates with altered levels of adipocytokines indicating its importance in diabetic individuals.

Association of Fasting Plasma Glucose and Serum Lipids in Type 2 Diabetics.

Dyslipidemia is a significant morbidity associated with diabetes and cardiovascular disorders. The present study was undertaken to assess the lipid profile of type 2 diabetic and age-gender matched healthy subjects and its association, if any, with fasting plasma glucose. Clinically diagnosed diabetic subjects were recruited for the study. The fasting plasma glucose and lipid profiles were analyzed for 99 diabetic and 101 healthy volunteers. The blood samples were analyzed for fasting plasma glucose, total cholesterol, triglycerides, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol and very low density lipoprotein-cholesterol. Correlation analysis of lipid profile with fasting plasma glucose and calculation of risk ratio was done. The levels of high density lipoprotein-cholesterol and low density lipoprotein-cholesterol were found to be significantly low in diabetics and subjects with lower low density lipoprotein-cholesterol were on statins. Inspite of lower lipid values, the risk ratio for diabetics was significantly higher. The correlation analysis indicated significant difference in relationship between fasting plasma glucose, lipid parameters and risk ratios in the two groups. Diabetics with lower high density lipoprotein-cholesterol and higher total cholesterol present with a higher risk ratio pointing to need of non-statin high density lipoprotein-raising medications decreasing their predisposition to cardiovascular disorders. The study highlights the altered pattern of correlation of lipid profile with fasting plasma glucose in diabetics and their increased risk of cardiovascular disorders. The dyslipidemia in the form of triglyceridemia and significantly low high density lipoprotein-cholesterol in diabetics point towards the need of non-statin high density lipoprotein-raising medications.

Circulatory adipocytokines and lipid profile variations in type-2 diabetic subjects: desirable side-effects of antidiabetic drugs.

AIM: Inspite of availability of a variety of drugs to treat type 2 diabetes, little is known about their effects on other systems. Normalization of glucose metabolism by these drugs may consequently affect the secretory function in adipocytes. Secretory adipocytokines like adiponectin and leptin are emerging as novel therapeutic targets for type 2 diabetes mellitus (T2DM). The present study was undertaken to analyze the effects of commonly used Oral Hypoglycemic Agents (OHAs) alone, or in combination with other drugs and/or insulin on circulatory adiponectin and leptin levels, lipid profile, and blood pressure in diabetic subjects. METHODS: The study was undertaken at IRSHA and Bharati Vidyapeeth Medical College and Hospital, MS, India. Clinically diagnosed T2DM subjects and age, gender matched healthy controls were recruited. Fasting blood was collected from each subject and the blood samples were analyzed for circulatory adipocytokines and lipid parameters using commercial kits. RESULTS: Serum adiponectin levels were significantly increased while leptin significantly decreased in diabetic men (p<0.05) and women (p<0.001) on OHA, as compared to healthy controls. Triglyceride levels significantly decreased (p<0.05) in diabetic men, however, they remained unchanged in women despite same drug treatment. Serum HDL and LDL levels (p<0.001) were significantly lower in diabetic women as compared to healthy women. Systolic (p<0.05) and diastolic (p<0.001) blood pressure was significantly high in diabetic men but remained unchanged in women. CONCLUSIONS: Frequently used OHAs significantly improve circulatory levels of adipocytokines. Selecting best treatment option for each patient is a key, and 2012 European Association for the Study of Diabetes (EASD) and ADA guidelines recommend diabetes treatment to be individualized depending on various socioeconomic and lifestyle factors. We recommend regular analysis of circulatory adipocytokines in T2DM patients to help clinicians select the best treatment option to normalize levels of these important therapeutic targets.