Preclinical Screening of Antidepressant Activity of Formulated Sertraline Hydrochloride-Loaded Solid Lipid Nanoparticles in Rats

Objective: The main goal of our study was to investigate the antidepressant activity of Formulated Sertraline hydrochloride-loaded Solid Lipid Nanoparticles (SLNPs) by using a rat forced swimming test (FST) and tail suspension test (TST). Materials and Methods: Animals were divided into three groups, consisting of six rats in each group. Out of these, one group served as control that received distilled water, second group was standard received Sertraline HCl (20 mg/kg intranasal) and third group was received test formulation (SLNPs 50 mg/kg intranasal). To assess the effect of SLNPs on immobility activity through FST and TST were used to take as a measure of antidepressant activity. Results: SLNPs reduced the immobility duration in TST as well as in FST. In both methods, there was a statistical significant decrease in immobility of SLNPs group when compared to the control group. Conclusion: The results suggested that SLNPs produced significant antidepressant effect in rats which was comparable with control group and standard Sertraline HCl group animals.

Virucidal activity of Nasaleze Cold® & Flu Blocker and Nasaleze® Travel in cell cultures infected with human pathogenic coronavirus 229-E

This in vitro study determined the anti-viral efficacy of a unique blend of powder cellulose supplemented with powdered garlic extract (PGE) and a signalling agent. The composition, presented as Nasaleze Cold & Flu Blocker/Nasaleze Travel, was assessed against Human Coronavirus 229E, CoV 229E {ATCC VR-740} in an in vitro experiment. The test substance was used at sub-optimal dosing levels to explore its prevention and treatment capabilities. The virucidal activity of this novel formulation was measured at 48, 72 and 112 hour periods after incubation. Results showed strong reductions in viral titre of Coronavirus 229E compared to a control, while no toxicity to human cells from the test formulation was noted. The extract Nasaleze Cold/Travel showed potential to be used as a therapeutic and preventive agent. The data reconfirms the established anti-viral activity of this formulation acting as a barrier preventing the virus from accessing the nasal mucosa and disrupting its replication.

Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers

Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120 mg tablet formulation. A dissolution study was conducted to optimize the formulation process before evaluating physical changes in the active pharmaceutical ingredient and the formulated product. Methods: This was a randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, two-way crossover, truncated bioequivalence study involving a washout period of ten days. A total of 26 healthy male volunteers were recruited. The pharmacokinetic profile of the test formulation was compared with the reference formulation. Results/Discussion: The pharmacokinetic parameters of ETO were calculated based on the plasma drug concentration-time profile using non-compartmental analysis to determine its safety profile and tolerability. The Test/Reference (T/R) ratio of ETO was 104.36% (90% confidence interval (CI): 98.30%–110.80%) for area under curve (AUC)0-72 while the T/R ratio of maximum concentration (Cmax) was 101.39% (92.15%–111.56%). The 90% CI of the Cmax and AUC0-72 of ETO were within acceptable bioequivalence limits of 80%–125%. All values were within the predetermined limits of the Association of Southeast Asian Nation (ASEAN) bioequivalence guidelines. Conclusion: The test formulation was found to be bioequivalent with respect to the reference drug, according to ASEAN bioequivalence guidelines.

Antioxidant and Anti-Inflammatory Activities of Biofield Energy Treated Proprietary Test Formulation in Brain Tissues in Cecal Slurry, LPS and E. Coli-Induced Systemic Inflammatory Response Syndrome (SIRS) in Sprague Dawley Rats

The study was aimed to evaluate the antioxidant and anti-inflammatory activity of the Biofield Energy Treated Proprietary Test Formulation and Biofield Energy Treatment per se to the animals on Cecal Slurry, LPS and E. coli-induced systemic inflammatory response syndrome (SIRS) model in Sprague Dawley rats. In this experiment, different antioxidants biomarkers such as myeloperoxidase (MPO), superoxide dismutase (SOD), lipid peroxidase (LPO) and cytokines like interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), macrophage inflammatory protein-2 (MIP-2) were analysed using ELISA assay in brain homogenate. A test formulation was formulated including minerals (magnesium, zinc, calcium, selenium, and iron), vitamin C, B6, E, B12, D3, β-carotene, cannabidiol isolate,and Panax ginseng extract. The component of the test formulation were divided into two parts; one section was defined as the untreated, while the other portion of each constituent and three group of animals received Biofield Energy Healing/Blessing Treatment remotely for about 3 minutes by Mr. Mahendra Kumar Trivedi, a renowned spiritual Energy Healer. The level of MPO was significantly (p≤0.001) reduced by 19.43%, 34.91%, 25.43%, 25.29% and 30.33% in the G5 (Cecal Slurry, LPS and E. coli + Biofield Energy Treated test formulation); G6 (Cecal Slurry, LPS and E. coli + Biofield Energy Treatment per se to animals from day -15); G7 (Cecal Slurry, LPS and E. coli + Biofield Energy Treated test formulation from day -15); G8 (Cecal Slurry, LPS and E. coli + Biofield Energy Treatment per se + Biofield Energy Treated/Blessed test formulation from day -15), and G9 (Cecal Slurry, LPS and E. coli + Biofield Energy Treatment per se animals + untreated test formulation) groups, respectively as compared to the untreated test formulation (G4) group. Moreover, the level of SOD was significantly increased by 45.02% (p≤0.001), 16.59%, and 35.99% (p≤0.001) in the G6, G7, and G9 groups, respectively as compared to G4 group. The level of TNF-α was significantly decreased by 12.66%, 46.92% (p≤0.001), 26.57% (p≤0.001), 23.22% (p≤0.001), and 54.28% (p≤0.001) in G5, G6, G7, G8, and G9 groups, correspondingly with reference to G4 group. Moreover, the level of IL-6 was significantly (p≤0.001) decreased by 37.51%, 20.28%, 21.55%, and 33.4% in the G6, G7, G8, and G9 groups, respectively as compared to the G4 group. Additionally, the level of MIP-2 was significantly (p≤0.001) reduced by 47.97%, 17.08%, 20.16% and 26.84% in the G6, G7, G8, and G9 groups, respectively as compared to the G4 group. Together, the data imply the antioxidant and anti-inflammatory potential of the Biofield Energy Treated test formulation and Biofield Energy Treatment per se along with preventive measure on the animal with respect to various inflammatory conditions that might be beneficial various types of systemic inflammatory disorders specially sepsis, trauma, septic shock or any types of injuries. Therefore, the results described a significant reduction of inflammation-related disease progression rate and its complications in the preventive maintenance groups (viz. G6, G7, G8, and G9).

Evaluation of Cardiac Performance after Treatment with the Biofield Energy Treated Proprietary Test Formulation on L-NAME and High Fat Diet-Induced Cardiovascular Disorders in Sprague Dawley Rats

Study was aimed to evaluate effect of Biofield Treated Proprietary Formulation and Biofield Treatment per se on cardiac performance on NG-nitro-L-arginine methyl ester hydrochloride (L-NAME) and high fat diet (HFD)-induced cardiovascular disorders in Sprague Dawley rats. Nine groups were assigned, in which four were preventive maintenance groups. The constituents of test formulation were divided into two parts; one section was defined as the untreated test formulation, while the other portion of the test formulation and three groups of animals received Biofield Energy Healing Treatment remotely for about 3 minutes by a renowned Biofield Energy Healer, Mr. Mahendra Kumar Trivedi. Systolic blood pressure (SBP) was significantly (p≤0.001) decreased by 13.39%, 14.65%, 17.74%, 14.36%, and 14.69% in the G5, G6, G7, G8, and G9 groups, respectively as compared to disease control (G2) group. Diastolic blood pressure (DBP)was significantly (p≤0.001) reduced by 25.95%, 24.41%, 30.79%, 24.67%, and 25.23% in G5, G6, G7, G8, and G9 groups, respectively than G2. Heart rate (HR) was significantly (p≤0.05) reduced by 6.58%, 8.06%, and 6.99% in G7, G8, and G9 groups, respectively than G2. Total leucocyte count (TLC) count was increased by 12.8% and 17.45% in G5 and G8 groups, respectively than G2 group. Neutrophils and lymphocytes were increased by 60.11% (G8) and 11.49% (G5), respectively than G2. Eosinophils were reduced by 11.11%, 20%, and 15% in G6, G7, and G9 groups, respectively than G2. Total cholesterol was significantly decreased by 22.64% (p≤0.05), 15.78%, 25.56% (p≤0.05), 22.56%, and 34.27% in G5, G6, G7, G8, and G9 groups, respectively than G2. Triglyceride was significantly (p≤0.001) reduced by 34.55%, 43.29%, 55.23%, 28.57%, and 37.28% in G5, G6, G7, G8, and G9 groups, respectively than G2. VLDL level was also significantly (p≤0.001) reduced by 80.81%, 83.61%, 86.82%, 79.19%, and 81.63% in G5, G6, G7, G8, and G9 group, respectively; while LDL was reduced by 20.32% (G9) group than G2. Atherogenic index (AI) was significantly (p≤0.001) decreased by 78.36%, 83.21%, 84.68%, 74.06%, and 72.98% in the G5, G6, G7, G8, and G9 groups, respectively than G2. The level of uric acid (UA) was significantly (p≤0.001) decreased by 57.51%, 52.36%, 45.49%, 43.78%, and 40.77% in the G5, G6, G7, G8, and G9 groups respectively, as compared with the G2 group. Serum glutamate pyruvate transaminases (SGPT) was significantly (p≤0.001) decreased by 45.96%, 48.01%, 37.19%, 37.69%, and 42.93% in the G5, G6, G7, G8, and G9 groups, respectively than G2. Creatine kinase myocardial band (CK-MB) level was significantly reduced by 10.19%, 21.97% (p≤0.01), 10.47%, and 16.94% in the G5, G6, G7, and G9 groups, than G2. Overall, the data suggested significance improvement of heart-related hematology, hepatic, and lipid parameters with respect to various pathological conditions that might be beneficial various types of cardiovascular disorders. Therefore, the results showed the significant slowdown the cardiovascular disease progression and its complications/symptoms in the preventive treatment groups viz. G6, G7, G8, and G9.

Evaluation of Antioxidative Potential of the Biofield Energy Treated Proprietary Test Formulation on L-NAME and High Fat Diet-Induced Cardiovascular Disorders in Sprague Dawley Rats

The aim of this experiment was to assess the antioxidative potential of the Biofield Energy Treated/Blessed Proprietary Test Formulation and Biofield Energy Treatment/Blessing per se to the animals on NG-nitro-L-arginine methyl ester hydrochloride (L-NAME) and high fat diet (HFD)-induced cardiovascular disorders in Sprague Dawley rats using various functional biomarkers. A test formulation was formulated including minerals (magnesium, zinc, copper, calcium, selenium, and iron), vitamins (ascorbic acid, pyridoxine HCl, vitamin B9, vitamin B12, and vitamin D3), cannabidiol (CBD) isolate, Panax ginseng extract, and β-carotene. The test formulation’s constituents were divided into two parts; one part was denoted as the untreated, while the other part and three group of animals received Biofield Energy Healing/Blessing Treatment remotely for about 3 minutes by a renowned spiritual leader, Mr. Mahendra Kumar Trivedi. The expression of superoxide dismutase (SOD) was elevated significantly by 198.46%, 208.73%, 191.73%, 211.75%, and 198.82% in the G5 (L-NAME + HFD + the Biofield Energy Treated test formulation), G6 (L-NAME + HFD + Biofield Energy Treatment per se to animals from day -15), G7 (L-NAME + HFD + the Biofield Energy Treated test formulation from day -15), G8 (L-NAME + HFD + Biofield Energy Treatment per se plus the Biofield Energy Treated test formulation from day -15), and G9 (L-NAME + HFD + Biofield Energy Treatment per se animals plus the untreated test formulation) groups, respectively than disease control group (G2). Moreover, the level of glutathione peroxidase (GPx) was significantly increased by 61.94%, 118.49%, 82.96%, 141.89%, and 262.02% in the G5, G6, G7, G8, and G9 groups, respectively as compared to the G2 group. Lipid peroxidase (LPO) was decreased by 14.21%, 30.98%, 38.66%, and 32.67% in the G6, G7, G8, and G9 groups, respectively than G2 group. Additionally, the level of myeloperoxidase (MPO) was decreased by 28.46%, 10.87%, 12.41%, and 13.35% in the G6, G7, G8, and G9 groups, respectively than G2. Further, the level of oxidized low density lipoprotein (LDL) was reduced by 65.38%, 65.11%, 71.53%, 79.26%, and 66.57% in the G5, G6, G7, G8, and G9 groups, respectively than G2. Besides, in heart tissues, the level of catalase (CAT) was significantly increased by 68.20%, 63.69%, 126.03%, 124.54%, and 112.23% in G5, G6, G7, G8, and G9 groups, respectively than G2 group. Moreover, in kidney tissues, the level of CAT was significantly increased by 22.48%, 23.43%, and 10.95% in the G6, G7, and G9 groups, respectively than G2. Overall, the data suggested a significant antioxidant activity by increasing the levels of SOD, CAT, GPx, and reducing the levels of LPO, MPO, and oxidized-LDL in various tissue fluids and that might be beneficial for cardiovascular disorders. Therefore, the study outcomes showed the significant slowdown the oxidative stress-related cardiovascular disease progression and its complications in the preventive treatment groups viz. G6, G7, G8, and G9.

Elasticity Profile of Skin, Neuronal, Cardiac, and Skeletal Muscle Cells after Treatment with the Biofield Energy Healing-Based Proprietary Test Formulation

The present study aimed to evaluate the effect of the Trivedi Effect®- Biofield Energy Treated/Blessed Test formulation/item (TI) composed of minerals (magnesium, zinc, copper, calcium, selenium, and iron), vitamins (ascorbic acid, pyridoxine HCl, alpha tocopherol, cyanocobalamin, and cholecalciferol), Panax ginseng extract, CBD isolates, and β-carotene on elasticity of skin, heart, muscle, and neuronal cells in the H9C2 (rat cardiomyocytes), C2C12 (mouse myoblast cells), HaCaT (human keratinocytes), and SH-SY5Y (human neuroblastoma cells) cell line in DMEM medium. The test formulation constituents were divided into two parts; one section was defined as untreated test formulation (UT), while the other portion of test formulation received Biofield Energy Healing/Blessing Treatment (BT) by a renowned Biofield Energy Healer, Mr. Mahendra Kumar Trivedi. The test items were treated with Biofield Energy Healing/Blessing Treatment and divided as Biofield Energy Treated/Blessed (BT) and untreated (UT) test items. MTT data showed that the test formulation in various concentrations was found as safe and nontoxic in the tested concentrations with viability range from 73% to 307%. Young’s modulus (YM) is a measure of cell stiffness, a decrease in YM value indicates increase elasticity of the cells and vice-versa. YM in H9C2 cells were decreased by 9.6% and 66.1% in the BT-DMEM + UT-TI group at 0.1 and 1 µg/mL respectively, as compared with untreated test group. However, C2C21 cells showed increased YM by 443.9% at 1 µg/mL in the UT-DMEM + BT-TI group, while 869.6% increased YM in the BT-DMEM + UT-TI group at 1 µg/mL as compared with untreated test group. However, 314% increased YM was reported in the BT-DMEM + BT-TI group at 1 µg/mL as compared with the untreated test group. However, the value of YM was significantly decreased in the HaCaT cell line by 247.7% (at 1 µg/mL), 225.8% (at 0.1 µg/mL), and 97.9% (at 1 µg/mL) in the UT-DMEM + BT-TI, BT-DMEM + UT-TI, and BT-DMEM + BT-TI group respectively, as compared with the untreated group. In addition, YM was significantly decreased in the SH-SY5Y cell line by 92.6%, 18.1%, and 26.6% at 1 µg/mL in the UT-DMEM + BT-TI, BT-DMEM + UT-TI, and BT-DMEM + BT-TI group respectively, as compared with the untreated group. Overall, the results showed the significant decreased YM among the SH-SY5Y, HaCaT, and H9C2 cells, while it was increased in the C2C21 cell line. Thus, the mechanical properties of cells such as cellular function, including shape, motility, differentiation, division, and adhesion to its surrounding extracellular matrix were improved. Overall, it can be useful in many disease progressions with improved cellular elasticity and its associated complications/symptoms.

Evaluation of Immunomodulatory Effect of a Novel Test Formulation in D-Galactose-Induced Aging Dysfunction in Sprague Dawley Rats

The aim of the study was to evaluate the immunomodulatory activity of the Biofield Treated/Blessed proprietary test formulation consisting of essential ingredients viz. minerals (zinc, magnesium, iron, and copper) and vitamins (B6, B12, and D3) in male Sprague Dawley rats. Each ingredient of the test formulation was divided into two parts. One part was denoted as the control without any Biofield Energy Healing Treatment/Blessing, while the other part was defined as the Biofield Energy Treated/Blessed sample, which received the Biofield Energy Healing Treatment/Blessing by a renowned Biofield Energy Healer, Mr. Mahendra Kumar Trivedi remotely. Additionally, three group of animals were also received Biofield Energy Treatment per se (at day -15) under similar conditions. The parameters were assessed such as immune biomarkers (IgM, IgG, IgA, IgE, CD4+, CD8+, and CD28+), biochemistry and hematology and histopathology. The experimental results showed IgG level was significantly increased by 10.70% and 8.03% in the G6 (Biofield Energy Treatment per se at day -15) and G8 (Biofield Treatment per se to animals plus Biofield Treated test formulation from day -15) groups, respectively as compared with untreated test formulation (G4). Additionally, CD8+ count was significantly increased by 20.67% in the G8 group, while CD28+ count was significantly increased by 11.70%, 8.32%, and 9.82% in the G7 (Biofield Energy Treated test formulation at day -15), G8, and G9 (Biofield Treatment per se (day -15) to animals plus untreated test formulation) groups, respectively after Biofield Energy Treatment to the animals as compared with the untreated test formulation. In hematological analysis, platelet count was increased in the G5, G6, G7, G8, and G9 groups by 40.69%, 27.95%, 26.67%, 38.58%, and 28.28%, respectively compared with the disease control (G2) group. Biochemical parameters showed significant decrease in the level of creatinine by 32.14% in the G9 group as compared with the G2 group. Further, animal body weight, feed intake, relative organ weight, and histopathological findings of all the tested groups did not show any abnormal findings with respect to the safe and non-toxic treatment strategies. Overall, the experimental data concluded that the Biofield Energy Treated/Blessed test formulation showed considerable improved cellular and humoral immune response as compared with the untreated test formulation. Thus, the Trivedi Effect®-Biofield Energy Healing Treatment per se and the test formulation has the significant capacity for immunomodulatory effect, stress management and anti-aging by improving overall health.

Evaluation of Renal and Cardioprotective Potential of the Biofield Energy Treated Proprietary Test Formulation on L-NAME and High Fat Diet-Induced Cardiovascular Disorders in Sprague Dawley Rats

The aim of this study was to evaluate the impact of Biofield Energy Treated/Blessed Proprietary Test Formulation and Biofield Energy Treatment/Blessing per se on kidney biomarkers on L-NAME and high fat diet (HFD)-induced cardiovascular disorders in Sprague Dawley rats. In this experiment, the functional kidney biomarkers such as epinephrine/adrenaline, inducible nitric oxide synthase (iNOS), angiotensin-II, C-reactive protein (CRP), and renin were measured using ELISA assay. A test formulation was formulated including minerals (magnesium, zinc, copper, calcium, selenium, and iron), vitamins (vitamin C, vitamin B6, vitamin B12, vitamin B9, and vitamin D3), cannabidiol (CBD) isolate, Panax ginseng extract, and β-carotene. The components of the test item were divided into two; one section was defined as the untreated test formulation, while the other part and three group of animals received Mr. Mahendra Kumar Trivedi’s Biofield Energy healing/Blessing remotely for about 3 minutes. The results showed that the level of adrenaline was reduced by 31.62%, 19.58%, 34.32%, 37.07%, and 29.87% in the G5 (L-NAME + HFD + the Biofield Energy Treated test formulation), G6 (L-NAME + HFD + Biofield Energy Treatment per se to animals from day -15), G7 (L-NAME + HFD + the Biofield Energy Treated test formulation from day-15), and G8 (L-NAME + HFD + Biofield Energy Treatment per se plus the Biofield Energy Treated test formulation from day-15), and G9 (L-NAME + HFD + Biofield Energy Treatment per se animals plus the untreated test formulation) groups, respectively as compared to the disease control group (G2). Moreover, the level of iNOS was reduced by 56.76%, 49.51%, 61.79%, 57.63%, and 62.44% in the G5, G6, G7, G8, and G9 groups, respectively, as compared to the disease control group (G2). Additionally, the level of angiotensin-II was decreased by 41.09%, 34.92%, 60.65%, 53.28%, and 60.09% in the G5, G6, G7, G8, and G9 groups, respectively, as compared to the G2 group. The level of CRP was decreased by 47.21%, 38.89%, 59.81%, 55.52%, and 64.02% in the G5, G6, G7, G8, and G9 groups, respectively as compared to the G2 group. Besides, the level of renin was decreased by 20.27%, 20.13%, 12.99%, and 25.73% in the G5, G7, G8, and G9 groups, respectively as compared to the G2 group. Overall, the data suggested significance improvement of vital functional kidney biomarkers of the Biofield Energy Treated/Blessed test formulation and Biofield Energy Treatment per se along with preventive measure on the animal with respect to various pathological conditions that might be beneficial various types of cardiovascular disorders. Therefore, the results showed the significant slowdown the inflammation-related cardiovascular disease progression and its complications/symptoms in the preventive Biofield Energy Treatment group per se and/or Biofield Energy Treated/Blessed Test formulation groups (viz. G6, G7, G8, and G9).