Clinical and Pre Clinical

Clinical & Pre-Clinical

Clinical studies on GutGard^®

A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of GutGard^® in the patients with functional dyspepsia.

Subjects	:	54 patients
Dose	:	75 mg twice daily
Duration	:	30 days
Results	:	GutGard^® treatment showed a marked improvement of 45% over placebo in the global assessment of efficacy, and significantly decreased the Nepean dyspepsia index on day 15 and day 30.

Preclinical studies on GutGard^®

Preclinical In vivo study

Anti-ulcer effect of GutGard^®was studied in various gastric ulcer models like pylorus ligation, cold-restraint stress- and indomethacin induced gastric mucosal injury in Albino Wistar rats. Anti-ulcer activity was evaluated by measuring the ulcer index, gastric content, total acidity, and pH of gastric fluid. GutGard^® dose dependently decreased gastric content (p ≤0.05), total acidity, ulcer index (p ≤0.05) and increased pH of gastric fluid in pylorus ligation ulcer model. In cold-restraint stress- and indomethacin induced ulcer models all the doses of GutGard^® decreased the ulcer index (p≤0.05) and increased the pH of gastric fluid.

Preclinical In vitro study

Inhibition of LPS induced release of NO, IL-1 and IL-6.

Pro-inflammatory cytokines are the cytokines that promotes systemic inflammation. Inflammation is a beneficial host response to a foreign challenge or tissue injury that ultimately leads to the restoration of normal tissue structure and function. Prolonged inflammation contributes to the pathogenesis of many inflammatory diseases. The main pro-inflammatory mediators include cytokines, primarily TNF- α, IL-1, and IL-6. We have studied the effect of GutGard^® on the release of IL-1 β, IL-6 and NO in LPS-induced murine macrophages.