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Poonam Ashish Gupte,1 Shital Ashok Giramkar,1 Shubhangi Mandar Harke,1 Sneha Keshav Kulkarni,1 Amol Panjabrao Deshmukh,2 Lal Lachhmandas Hingorani,2 Madhavi Prabhakar Mahajan,3 Supriya Sudhakar Bhalerao11Obesity Diabetes lab, Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth Deemed University Campus, Pune, Maharashtra, India; 2Research and Development Department, Pharmanza Herbals Pvt. Ltd., Dharmaj, Gujrat, India; 3College of Ayurved, Bharati Vidyapeeth Deemed University Campus, Pune, Maharashtra, IndiaPurpose: 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, IL1β 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

Context: Acid peptic disorders., Aims: This study aimed to assess the efficacy and acceptability of pomegranate effervescent granules (PEGs) in dyspeptic patients., Settings and Design: It was a single-arm, open-labeled prospective multicentric clinical study, done at 3 centers: Vishwanand Kendra, Pune; Bharati Ayurved Hospital, Bharati Vidyapeeth, Pune, and M. A. Podar Medical Ayurved Hospital, Mumbai. The co-ordinating site was Interactive Research School for Health Affairs, Bharati Vidyapeeth, Pune., Materials and Methods: The granules, prepared from peel extract of pomegranate, were made available in sachets of 2.5 g with dose of, 1 sachet dissolved in 200 ml (1 cup) of water, twice a day after meals for 28 days. Gastrointestinal Symptom Rating Scale (GSRS) scores to assess symptoms of acid peptic disorders at day 0, 15, and 29 along with the taste of formulation were the main study outcomes., Statistical Analysis Used: Parametric data, presented as mean ± standard deviation, were analyzed using paired t-test, while nonparametric data presented as median (range) was analyzed using Wilcoxon rank-sum test. Categorical data were analyzed using Chi-square test., Results: The median GSRS score reduced from 14 on day 0-10 and then 5 on day 15 and day 29, respectively, with statistical significance. The formulation was found to taste good by ~80% of patients, while ~20% reported it to be palatable and none found it to be bad in taste., Conclusion: PEGs proved to be palatable, patient-friendly, safe, and efficacious in resolving symptoms of dyspepsia in acid peptic disorders., Ctri Registration: The trial was registered retrospectively in the Clinical Registry of India [CTRI/2017/07/008999]., Competing Interests: None

Background: In Ayurveda, several herbs and formulations are available for the treatment of Urolithiasis. However, they are not systematically evaluated for their safety, efficacy, indication and limitations. Herbmed Plus is one such herbal formulation that has been known for the management of urinary tract disorders. An attempt has been made to evaluate its efficacy on Urolithiasis., Objective: To evaluate the efficacy and safety of Herbmed Plus in urolithic rats., Materials and Methods: A total of 60 Wistar albino rats were used for this study. The male and female rats were divided into five groups: disease control, test (dose 90 mg/kg), standard I (Cystone), standard II (Alkaston insta) and normal control (six in each group). Urolithiasis was induced using ethylene glycol 0.75% in drinking water for 28 days. The rats with urinary oxalate crystals were dosed with oral test or standard treatments for 28 days., Results: All the animals appeared normal and showed no clinical signs of toxicity. None of the groups reported mortality or adverse effect on body weight and food consumption. The treatment with test drug showed improvement in the SGPT level and urine output (5.4 vs 3.47 mL/24 h). A drastic reduction in number of crystals were observed in male 0.5 vs 22 and female rats 0 vs 22.7 in test and disease group. The kidney lactate dehydrogenase, alkaline phosphatase, urinary phosphorus and calcium oxalate level decreased in the test and standard drug groups as compared to disease groups. Microscopy of the urine samples showed reduction in the number of crystals after treatment compared to the urolithic group. Increase in citrate levels in urine in all the treatment groups indicated anti-urolithiatic activity. The test group showed a 69.70% recovery in males and 47.57% recovery in female rats compared to the disease control group., Conclusion: Herbmed Plus showed a significant reduction in oxalate synthesizing enzymes suggesting anti-urolithiatic activity and anti-inflammatory and regenerative property in cellular injury caused by crystal deposits., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

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, IL1β 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., Competing Interests: The authors report no conflicts of interest in this work.

Background: Lichen planus (LP), a T-cell-mediated inflammatory disorder, wherein inflammation produces lipid metabolism disturbances, is linked to increase in cardiovascular (CV) risk with dyslipidemia. Increased reactive oxygen species and lipid peroxides have also been implicated in its pathogenesis., Aim and Objective: The aim of the study was to evaluate the status on lipid disturbances, oxidative stress, and inflammation in LP patients., Materials and Methods: The study was initiated after obtaining Institutional Ethics Committee permission and written informed consent from participants. The study included 125 patients (74 LP patients and 51 age and sex-matched controls) visiting the outpatient clinic in the dermatology department of our hospital. Variables analyzed included lipid profile, C-reactive protein (CRP), malondialdehyde (MDA), and catalase (CAT) activity., Results: Analysis of lipid parameters revealed significantly higher levels of total cholesterol (TC), triglycerides, and low-density lipoprotein cholesterol (LDL-C) along with decreased levels of high-density lipoprotein cholesterol (HDL-C) in LP patients as compared to their respective controls. LP patients also presented with a significantly higher atherogenic index that is, (TC/HDL-C) and LDL-C/HDL-C ratios than the controls. A significant increase in CRP levels was observed among the LP patients. There was a statistically significant increase in the serum levels of the lipid peroxidation product, MDA and a statistically significant decrease in CAT activity in LP patients as compared to their respective controls. A statistically significant positive correlation (r = 0.96) was observed between serum MDA levels and duration of LP whereas a significantly negative correlation (r = -0.76) was seen between CAT activity and LP duration., Conclusion: Chronic inflammation in patients with LP may explain the association with dyslipidemia and CV risk. Our findings also suggest that an increase in oxidative stress and imbalance in the antioxidant defense mechanisms in LP may play a role in the pathogenesis of LP.

Background: Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies) in four Indian journals., Materials and Methods: Original research articles published over a period of 4 years (2009-2012) in four major national clinical journals, viz. Journal of Association of Physicians of India (JAPI), Indian Journal of Surgery (IJS), Journal of Obstetrics and Gynecology of India (JOGI), and Indian Journal of Orthopedics (IJO) were reviewed with regard to documentation of ethics approval and written informed consent and assent in case of pediatric participants., Results: We reviewed 673 research articles and found that, overall ethical approval was mentioned in 163 (24.2%) and informed consent or assent was mentioned in 179 (26.5%) articles in all four journals. Individually we found, in JAPI of the 174 manuscripts reviewed, 74 (42.5%) reported having obtained approval from the ethics committee and 68 (39.1%) reported taking written informed consent from participants. In IJS of 123 manuscripts, 18 (14.6%) reported ethics committee approval and 20 (16.2%) reported informed consent from participants. In JOGI of 152 manuscripts, 21 (13.8%) reported ethics committee approval while 49 (32.2%) reported informed consent from participants. In IJO, of 224 manuscripts, 50 (22.3%) reported ethics committee approval and 42 (18.7%) reported obtaining informed consent., Conclusion: Majority of the publications did not provide information regarding compliance to ethical guidelines in spite of the availability of various guidelines. Thus, there is a need for awareness and training on bioethics for authors, reviewers, and editors of biomedical journals.

Objective: Measurement of glucose uptake into peripheral tissue is an important mechanism to assess Insulin sensitivity. The present in vitro study was conducted to evaluate the Insulin sensitizing activity of Phyllanthus emblica (Pe), Tinospora cordifolia (Tc) and Curcuma longa (Cl) by assessing glucose uptake activity in a 3T3L1 adipocyte model., Materials and Methods: The 3T3 L1 fibroblast cells were differentiated to adipocytes, using a cocktail of insulin, isobutyl-1-methylxanthine and dexamethazone. These adipocytes were initially treated with different concentrations of the selected plants following which 2-deoxy glucose uptake was estimated using a radioactive assay. The effects of plants on glucose uptake both in the presence and absence of insulin was evaluated and compared with pioglitazone, a known insulin sensitizer., Results: Pe and Tc per se significantly stimulated glucose uptake in 3T3-L1 adipocytes in a dose dependent manner with maximal effect at higher concentrations (200 μg/ml). The effect of both Pe and Tc at 200 μg/ml was comparable to insulin and greater than pioglitazone. Cl per se stimulated glucose uptake with maximal effect at 50 μg/ml. However, this effect was lesser as compared to insulin with higher concentrations inhibiting glucose uptake. When combined with insulin, an antagonist effect was observed between Pe, Tc and insulin indicating a possible plant-drug interaction while Cl in combination with insulin showed an increase in the glucose uptake as compared to Cl alone., Conclusion: The results suggest that one of the mechanisms for the anti-diabetic effect of Pe, Cl and Tc may be through an insulin sensitizing effect (stimulation of glucose uptake into adipocytes). Further studies using other target sites viz. skeletal muscle and hepatocytes models and in an insulin resistant state would help substantiate this conclusion.

Aspergillosis of the nasal and paranasal sinuses is recognized as being second to candidiasis, among opportunistic fungal infections in immunocompromised patients. However, invasive variant in normal and mildly immunocompromised hosts is a very rare occurrence. We report one such case of aspergillosis involving paranasal sinuses in mildly immunocompromised patient.

Salicylic acid has been used widely in the treatment of dry skin conditions and also helps reduce acne symptoms. However, it suffers from the disadvantages of being a mild to strong irritant. Hence, its control can be achieved through encapsulation in liposomes. Liposomes were prepared by the conventional thin film hydration technique as described by Bangham et al. (J. Mol. Biol., 1965). The prepared liposomal dispersions were then characterized for entrapment efficiency, particle size by transmission electron microscopy (TEM), phase transition studies by differential scanning calorimetry (DSC), and lamellarity by nuclear magnetic resonance (NMR). The results showed the formation of bilayered liposomes in the particle size range of 0.2-0.8276 microm with a maximum entrapment efficiency of 42.6%. The liposomes stored at 4-5 degrees C demonstrated maximum stability as compared to those stored at any other temperature.

Diltiazem hydrochloride-ethylcellulose microspheres were prepared by the water-in-oil emulsion-solvent evaporation technique. Small and spherical microspheres having a mean microsphere diameter in the range of 40-300 microm and entrapment efficiency of approximately 60-90% were obtained. Scanning electron micrographs of drug-loaded microspheres showed the presence of uniformly distributed small pores and absence of drug crystals on their surface, indicating simultaneous precipitation of drug and the polymer from the solvent during solvent evaporation. Differential scanning calorimetric analysis confirmed the absence of any drug-polymer interaction. The in vitro release profile could be altered significantly by changing various processing parameters to give a controlled release of drug from the microspheres. The stability studies of the drug-loaded microspheres showed that the drug was stable at storage temperatures, 5-55 degreesC, for 12 weeks.