A Study to Evaluate the Effect of Alpha-Lipoic Acid on Neuropathic Symptoms in Diabetic Neuropathy Patients on Gabapentin or Pregabalin.

Introduction Chronic hyperglycemia is a key factor in the development of diabetic peripheral neuropathy (DPN), contributing significantly to the progression of this condition through the induction of oxidative stress. Elevated blood glucose levels lead to increased production of reactive oxygen species (ROS), which cause damage to neuronal cells and exacerbate neuropathic symptoms. Alpha-lipoic acid (ALA) is a potent antioxidant that neutralizes ROS and reduces oxidative damage.

Shilajit extract reduces oxidative stress, inflammation, and bone loss to dose-dependently preserve bone mineral density in postmenopausal women with osteopenia: A randomized, double-blind, placebo-controlled trial.

Background: Accelerated bone loss associated with aging and estrogen withdrawal is mediated in part by increased oxidative stress and inflammation.

Objective: Investigate dietary supplementation with a standardized aqueous extract of shilajit with clinically demonstrated antioxidant, anti-inflammatory, and collagen-promoting activity on attenuating bone loss in postmenopausal women with osteopenia.

Design: Sixty postmenopausal women aged 45 - 65 years with osteopenia were randomized to receive 1 of 3 treatments daily for 48 weeks: (1) placebo, (2) 250 mg shilajit extract, or (3) 500 mg shilajit extract.

Aqueous (Neem) Extract Attenuates Insulin Resistance to Improve Glycemic Control and Endothelial Function in Subjects with Metabolic Syndrome.

Neem () exhibits multiple therapeutic benefits in preclinical studies, but clinical studies are lacking. This clinical study investigated the efficacy and safety of an aqueous leaf and twig extract (NEEM) on metabolic parameters in subjects with metabolic syndrome (MetS). Subjects were randomized to receive (1) placebo or (2) 125 mg, (3) 250 mg, or (4) 500 mg of NEEM twice daily ( = 20/group) for 12 weeks.

Effect of Omega-3 Fatty Acid Alone and in Combination with Proprietary Chromium Complex on Endothelial Function in Subjects with Metabolic Syndrome: A Randomized, Double-Blind, Parallel-Group Clinical Study.

Metabolic syndrome (MetS) represents a cluster of metabolic abnormalities that include hypertension, central obesity, insulin resistance, and dyslipidemia and is strongly associated with an increased risk of diabetes, cardiovascular diseases (CVD), and all-cause mortality. Early diagnosis is important to employ lifestyle and risk factor modification. Existing therapies are limited.

Evaluation of the Effect of an Aqueous Extract of (Neem) Leaves and Twigs on Glycemic Control, Endothelial Dysfunction and Systemic Inflammation in Subjects with Type 2 Diabetes Mellitus - A Randomized, Double-Blind, Placebo-Controlled Clinical Study.

Purpose: Neem tree () offers different bioactives ranging from pesticides to therapeutic molecules, depending on which part of the plant is used and the extraction methodology and the solvent used. This study was aimed at evaluating the safety and efficacy of a standardized aqueous extract of leaves and twigs (NEEM) on glycemic control, endothelial dysfunction, and systemic inflammation in patients with type 2 diabetes mellitus (T2DM).

Methods: In this randomized, double-blind, placebo-controlled clinical study (RCT), 80 T2DM subjects, who have already been on standard metformin therapy, received either 125 mg, 250 mg, 500 mg of NEEM or placebo twice daily for 12 weeks.

A randomized, double-blind, positive-controlled, prospective, dose-response clinical study to evaluate the efficacy and tolerability of an aqueous extract of Terminalia bellerica in lowering uric acid and creatinine levels in chronic kidney disease subjects with hyperuricemia.

Background: Hyperuricemia is an independent risk factor in chronic kidney disease (CKD). Allopurinol and febuxostat are prescription medicines used to treat hyperuricemia but suffer side-effects. Earlier clinical study has shown that an aqueous extract of Terminalia bellerica (TBE), significantly reduced uric acid levels with no serious adverse effects in hyperuricemic subjects.

Effect of an aqueous extract of Terminalia chebula on endothelial dysfunction, systemic inflammation, and lipid profile in type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical study.

Endothelial dysfunction is a crucial complication in type 2 diabetic patients, related to cardiovascular risk. Terminalia chebula (TC), a traditional ayurvedic herb, is known for its antioxidant and antihyperlipidemic activity. A prospective, randomized, double-blind, placebo-controlled clinical study was undertaken to evaluate the effects of an aqueous extract of T.

Evaluation of the Effect of Fish Oil Alone and in Combination with a Proprietary Chromium Complex on Endothelial Dysfunction, Systemic Inflammation and Lipid Profile in Type 2 Diabetes Mellitus - A Randomized, Double-Blind, Placebo-Controlled Clinical Study.

Purpose: This study was conducted to evaluate the effectiveness of fish oil alone and with an adjunct, a proprietary chromium complex (PCC), on cardiovascular parameters - endothelial dysfunction, lipid profile, systemic inflammation and glycosylated hemoglobin - in a 12-week randomized, double-blind, placebo-controlled clinical study in type 2 diabetes mellitus subjects.

Patients And Methods: In this randomized, double-blind, parallel group study, 59 subjects in three groups completed the study: Group A, fish oil 2000 mg; Group B, fish oil 2000 mg + PCC 10 mg (200 µg of Cr); and Group C, fish oil 2000 mg + PCC 20 mg (400 µg of Cr) daily for 12 weeks (2000 mg of fish oil contained 600 mg of eicosapentaenoic acid [EPA] and 400 mg of docosahexaenoic acid [DHA], the omega-3 fatty acids). Endothelial function, by estimating reflection index (RI), biomarkers of oxidative stress (nitric oxide [NO], malondialdehyde [MDA], glutathione [GSH]) and inflammatory biomarkers (high-sensitivity C-reactive protein [hsCRP], intercellular adhesion molecule-1 [ICAM-1], vascular cell adhesion molecule-1 [VCAM-1], endothelin-1) were evaluated at baseline, and 4 and 12 weeks.

Evaluation of the effects of a standardized aqueous extract of Phyllanthus emblica fruits on endothelial dysfunction, oxidative stress, systemic inflammation and lipid profile in subjects with metabolic syndrome: a randomised, double blind, placebo controlled clinical study.

Background: Endothelial dysfunction (ED) has been observed in individuals with metabolic syndrome (MetS) and contributes to the initiation and progression of atherosclerosis. The primary management of MetS involves lifestyle modifications and treatment of its individual components with drugs all of which have side effects. Thus, it would be of advantageous if natural products would be used as adjuncts or substitutes for conventional drugs.

A randomized, double-blind, placebo-controlled, cross-over study to evaluate analgesic activity of Terminalia chebula in healthy human volunteers using a mechanical pain model.

Background And Aims: To evaluate analgesic activity and safety of single oral dose (1000 mg) of Terminalia chebula using a mechanical pain model in healthy human volunteers.

Material And Methods: Twelve healthy volunteers were randomized to receive either single oral dose of 2 capsules of T. chebula 500 mg each or identical placebo capsules in a double-blinded manner.

A randomized, double-blind, placebo-, and positive-controlled clinical pilot study to evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica in subjects with hyperuricemia.

Objectives: To evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica versus febuxostat and placebo on reduction in serum uric acid levels in subjects with hyperuricemia.

Materials And Methods: A total of 110 eligible subjects with hyperuricemia were enrolled and randomized to either of the five treatment groups - T. chebula 500 mg twice a day (BID), T.

Evaluation of the Analgesic Activity of Standardized Aqueous Extract of Terminalia chebula in Healthy Human Participants Using Hot Air Pain Model.

Background: Pain affects millions of people worldwide, opioid analgesics have been used for chronic painful conditions. Due to their adverse effects, safer alternatives would be beneficial. Terminalia chebula, with proven analgesic action has been evaluated in the hot air pain model for its analgesic activity.

Epidermal growth factor receptor (EGFR) mutations as biomarker for head and neck squamous cell carcinomas (HNSCC).

Context: Mutations in tyrosine kinase domain (TK) of epidermal growth factor receptor (EGFR) lead to signalling interruptions in several cancers.

Objective: To understand EGFR mutations in head and neck squamous cell carcinomas (HNSCC), and their role as biomarkers.

Methods: Screened 129 HNSCC patients and 150 controls for mutations in the TK domain using polymerase chain reaction (PCR), single strand confirmatory polymorphism (SSCP) and sequencing.

Evaluation of Phyllanthus emblica extract on cold pressor induced cardiovascular changes in healthy human subjects.

Background: Acute and chronic stress is a risk factor for the development and progression of coronary artery disease. Increased arterial stiffness is an independent marker for cardiovascular disease. Cold pressor test (CPT) is known to be associated with substantial activation of the autonomic nervous system.

Effect of standardized aqueous extract of Withania somnifera on tests of cognitive and psychomotor performance in healthy human participants.

Background: Withania somnifera is an herbal medicine that has been known to possess memory-enhancing properties. The current study involved an assessment of cognitive and psychomotor effects of Withania somnifera extract in healthy human participants.

Materials And Methods: In this prospective, double-blind, multi-dose, placebo-controlled, crossover study, 20 healthy male participants were randomized to receive 250 mg two capsules twice daily of an encapsulated dried aqueous extract of roots and leaves of Withania somnifera or a matching placebo for a period of 14 days.

Study of pharmacodynamic interaction of Phyllanthus emblica extract with clopidogrel and ecosprin in patients with type II diabetes mellitus.

Background: Diabetes mellitus is associated with oxidative stress which impairs the platelet function. Phyllanthus emblica extract a rich source of vitamin C plays an important role in scavenging free radicals. The effect of vitamin C on platelet aggregation in healthy and coronary artery disease patients has been demonstrated.

Evaluation of a new computerized psychometric test battery: Effects of zolpidem and caffeine.

Objective: To evaluate the effects of centrally active drugs using a new indigenously developed automated psychometric test system and compare the results with that obtained using pencil- and paper-based techniques.

Materials And Methods: The tests were standardized in 24 healthy participants. Reproducibility of the test procedure was evaluated by performing the tests by a single experimenter on two occasions (interday reproducibility).

Effects of Phyllanthus emblica extract on endothelial dysfunction and biomarkers of oxidative stress in patients with type 2 diabetes mellitus: a randomized, double-blind, controlled study.

Background: It has been reported that hyperglycemia can induce endothelial dysfunction via increased oxidative stress and that it plays a central role in the development of atherosclerosis and coronary heart disease. Phyllanthus emblica (Emblica officinalis, amla) is known for its antioxidant and antihyperlipidemic activity. The present study compared the effects of an aqueous extract of P.

Randomized, single-blind, crossover comparison of two rupatadine tablet formulations on histamine-induced cutaneous response in healthy adult volunteers.

Background: Rupatadine is a histamine receptor type 1 antagonist that has been used to treat allergic rhinitis and urticaria.

Objective: The aim of this study was to compare the effect of 2 rupatadine tablet formulations on the inhibition of histamine-induced wheal-and-flare cutaneous responses.

Methods: In this single-blind, single oral dose, crossover study, healthy male volunteers were randomized to receive 10 mg of either a rupatadine reference or test formulation after an overnight fast.