A prospective, single centre, open label, single arm pilot study to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with endoscopic gastritis.

BACKGROUND: Endoscopic gastritis is associated with symptoms of gastritis, along with endoscopic findings. Amlapitta Mishran has multiple active components that act via various mechanisms in patients with gastritis symptoms. We planned to conduct this study to find out the efficacy and safety of Amlapitta Mishran in patients with endoscopic gastritis. OBJECTIVES: To find out efficacy of Amlapitta Mishran in patient with endoscopic gastritis. MATERIALS AND METHODS: This study was an open-label, prospective, single-center study. Thirty participants were recruited, and Amlapitta Mishran Suspension was given for 30 days. Blood investigations for safety were performed at baseline (Visit 1), on Visit 3 and Visit 4. Endoscopy was performed at baseline and Visit 4, and stomach erosion score was recorded. Amlapitta Symptom Rating Scale score, Postprandial Distress Syndrome (PPDS) score, and Epigastric Pain Syndrome (EPS) score were efficacy endpoints. RESULTS: Out of the 30 participants recruited, 28 participants completed the study. The median age of participants in the study was 26.50 years. A statistically significant (P<0.05) reduction was seen in endoscopy score at Visit 4 as compared to baseline (Visit 1) by Wilcoxon Signed Rank test. Amlapitta Symptom Rating Scale score, PPDS score, EPS score also exhibited significant reduction (P < 0.05) at Visit 3 and Visit 4 as compared to baseline by Friedman's test with post hoc analysis. No statistically significant reduction was seen in these scores from Visit 3 to Visit 4, except for the EPS score. At the end of Visit 4, 18 (64%) participants had an endoscopy score of 1 (no erosions). At the end of Visit 4, ≥ 50% improvement was seen in Amlapitta Symptom Rating Scale score in 27 (96%) participants, PPDS score improved by ≥ 50% in 25 (89%) participants, and EPS score improved by ≥ 50% in 26 (93%) participants. All safety variables including laboratory investigation were within the normal range in all visits. CONCLUSION: Amlapitta Mishran Suspension effectively reduced endoscopic gastritis scores in the participants and reduced the symptoms of gastritis measured by the Amlapitta Symptom Rating Scale, PPDS, and EPS scores with no adverse events.

An open-label, prospective, multicenter, clinical study to evaluate efficacy of Ayuartis capsules in patients suffering from osteoarthritis of the knee(s).

BACKGROUND: The management of chronic degenerative joint disorders such as osteoarthritis (OA) with ayurvedic medicines provides a safe and effective alternative. Ayurvedic medicines possess analgesic, anti-inflammatory, anti-oxidant and immunomodulator activities. AIMS: The main aim of the study was to assess the efficacy of Ayuartis capsule in patients suffering from OA of the knee(s). MATERIALS AND METHODS: Thirty-one patients suffering from OA knee(s) were recruited after evaluating them as per inclusion/exclusion criteria. Patients were advised to take two Ayuartis capsules twice daily orally for 90 days. Knee joint(s) pain was assessed on the Visual Analog Scale. Patients' joint pain, stiffness, and physical functions were assessed on the Western Ontario McMaster University Osteoarthritis (WOMAC) index. Quality of life (QOL) and the time required to walk 50 feet was evaluated. Patients were called for follow-up visits on every 15th day till 90 days. Adverse events and vitals were recorded at every visit. Safety laboratory investigations were done before and after the completion of trial. STATISTICAL ANALYSIS: Data describing quantitative measures are expressed as mean ± standard deviation. The comparison of variables representing categorical data was performed using pair t-test. RESULTS: The mean joint pain reduced significantly by 53.82% on day 90. The mean WOMAC combined score, pain score, stiffness score and difficulty score reduced significantly by 50.88%, 54.96%, 58.76% and 49.02%, respectively on day 90. A significant improvement was observed in mean QOL of patients. A significant reduction in mean time required to walk 50 feet was observed. Majority of the patients had shown good overall improvement and excellent tolerability to the trial drug. CONCLUSION: Ayuartis capsule is a safe and effective medicine for the treatment of OA of the knee(s).

Polysaccharide rich extract (PRE) from Tinospora cordifolia inhibits the intracellular survival of drug resistant strains of Mycobacterium tuberculosis in macrophages by nitric oxide induction.

Plethora of clinical and scientific information obtained in recent past has strengthened the idea that targeting critical constituents of host immune system may have beneficial outcomes for the treatment of tuberculosis. Macrophages being the primary host for Mycobacterium tuberculosis, offer an attractive target for modulation. Owing to their negligible toxicity, plant derived polysaccharides with the ability to activate macrophages; are suitable candidates for immunomodulation. In the present study, effects of polysaccharide rich extract (PRE) isolated from Tinospora cordifolia, on the survival of intracellular MTB strains and activation of macrophages were investigated. PRE treatment up regulated the expression of pro-inflammatory cytokines such as IL-ß, TNF-α, IL-6, IL-12, and IFN-γ in RAW 264.7 cell line. Up regulation in the expression of NOS2 was observed along with concomitant enhanced nitric oxide production post PRE treatment. Surface expression of MHC-II and CD-86 was up regulated after PRE treatment. Above results suggested the classical activation of macrophages by PRE treatment. Furthermore, PRE treatment led to the activation of all the three classes of MAPK i.e p38, ERK and JNK MAPKs. Further, PRE up regulated the expression of cytokines, NOS-2, MHC-II and CD-86 in MTB infected macrophages. PRE treatment inhibited the intracellular survival of drug resistant MTB in macrophages which was partially attributed to PRE mediated NO induction. Thus our data demonstrate classical activation of macrophages by PRE treatment and killing of intracellular MTB by NO induction.

G1-4A, a Polysaccharide from Tinospora cordifolia Inhibits the Survival of Mycobacterium tuberculosis by Modulating Host Immune Responses in TLR4 Dependent Manner.

Rapid emergence of drug resistance in Mycobacterium tuberculosis (MTB) is a major health concern and demands the development of novel adjunct immunotherapeutic agents capable of modulating the host immune responses in order to control the pathogen. In the present study, we sought to investigate the immunomodulatory effects of G1-4A, a polysaccharide derived from the Indian medicinal plant Tinospora cordifolia, in in-vitro and aerosol mouse models of MTB infection. G1-4A treatment of MTB infected RAW264.7 macrophages significantly induced the surface expression of MHC-II and CD-86 molecules, secretion of proinflammatory cytokines (TNF-α, IL-ß, IL-6, IL-12, IFN-γ) and nitric oxide leading to reduced intracellular survival of both drug sensitive (H37Rv) as well as multi drug resistant strains (Beijing and LAM) of MTB, which was partially attributed to G1-4A induced NO production in TLR4-MyD88 dependent manner. Similarly, bacillary burden was significantly reduced in the lungs of MTB infected BALB/c mice treated with G1-4A, with simultaneous up-regulation of the expression of TNF-α, INF-γ and NOS2 in the mouse lung along with increased levels of Th1 cytokines like IFN-γ, IL-12 and decreased levels of Th2 cytokine like IL-4 in the serum. Furthermore, combination of G1-4A with Isoniazid (INH) exhibited better protection against MTB compared to that due to INH or G1-4A alone, suggesting its potential as adjunct therapy. Our results demonstrate that modulation of host immune responses by G1-4A might improve the therapeutic efficacy of existing anti-tubercular drugs and provide an attractive strategy for the development of alternative therapies to control tuberculosis.

Validated high-performance thin-layer chromatographic method for the quantification of thymoquinone in Nigella Sativa extracts and formulations.

INTRODUCTION: The surge of interest in naturally occurring phytochemicals with anticancer potential has led to the discovery of many molecules, one of them being thymoquinone (TQ) the bioactive constituent of the volatile oil of black seed, Nigella sativa L. (NS). OBJECTIVE: The aim of the present work was to develop and validate an HPTLC method for determination of TQ in NS extracts, commercially available marketed oils, polyherbal formulations and in lipid-based oral and parenteral formulations prepared in-house. METHODOLOGY: Analysis of TQ was performed on TLC aluminium plates pre-coated with silica gel 60F-254. Linear ascending development was carried out in twin trough glass chamber, saturated with mobile phase consisting of toluene-cyclohexane (8 : 2, v/v) at ambient temperature. Camag TLC scanner III was used for the spectrodensitometric scanning and analysis in absorbance mode at 254 nm. RESULTS: The method was found to give compact spots for TQ (R(f) value of 0.28 ± 0.05) and was linear over the range 100-1400 ng/spot (r(2) = 0.9921 ± 0.0020). Accuracy, precision and repeatability were all within the required limits. The mean recoveries measured at three concentrations were higher than 95% with RSD ≤ 3%. CONCLUSION: The HPTLC method developed was found to be relatively simple, rapid and accurate for the routine analysis of TQ in extracts, marketed oils, polyherbal and in-house formulations.