Preclinical Studies on GutGard™
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| In vivo studies on GutGard™ |
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| Anti-ulcer effect of GutGard™ (12.5, 25, and 50 mg/kg, p.o.) was studied in various gastric ulcer models like pylorus ligation-, cold-restraint stress- and indomethacin induced gastric mucosal injury in 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. |
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 Anti-ulcer potential of GutGard™ in pylorus ligation induced ulcer model |
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| Animals |
Albino Wistar rats (either sex). |
| Test material |
GutGard™ |
| Standard |
Omeprazole |
| Dose |
Omeprazole (10 mg/kg), GutGard™ (12.5, 25 & 50 mg/kg). |
| Results |
GutGard™ showed a significant anti-ulcer activity in pylorus ligation induced ulcer model in a dose dependent manner. |
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| Anti-ulcer potential of GutGard™ in indomethacin induced ulcer model |
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| Animals |
Albino Wistar rats (either sex). |
| Test material |
GutGard™ |
| Standard |
Omeprazole |
| Dose |
Omeprazole (10 mg/kg), GutGard™ (12.5, 25 and 50 mg/kg). |
| Results |
GutGard™ showed a significant reduction in ulcer index in indomethacin induced ulcer model. |
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| Anti-ulcer potential of GutGard™ in cold stress induced ulcer model |
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| Animals |
Albino Wistar rats (either sex). |
| Test material |
GutGard™ |
| Standard |
Omeprazole |
| Dose |
Omeprazole (10 mg/kg), GutGard™ (12.5, 25 & 50 mg/kg). |
| Results |
There was a significant decrease in ulcer index scores of GutGard™ in all the tested doses. |
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| In-vitro studies on GutGard™ |
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| Anti-H. pylori activity |
Gastric acid is still considered as a significant factor in ulcer formation, but the leading cause of ulcer disease is by infection of the stomach by a bacterium called "Helicobacter pylori". H. pylori is a spiral-shaped, gram-negative bacterium that colonizes in the human stomach and it is the only known microorganism that can thrive in the high acidic environment of the stomach. H. pylori infects the mucus lining of the stomach and duodenum. Many cases of peptic ulcer, gastritis and duodenitis are caused by H. pylori infection.
Two independent Indian laboratories i.e., Indian Institute of Chemical Biology, Kolkata and Amity University, New Delhi have confirmed anti-H. pylori potential of GutGard™ |
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| Antioxidant assays |
Increased oxidative stress represents an important mechanism leading to epithelial injury in H. pylori infection. Both bacterial and host factors contribute to the oxidative stress induced by infection.
Various factors responsible for induction of oxidative stress in H. pylori infected human gastric epithelial cells are:
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 Generation of reactive oxygen species (ROS) by H. pylori.
Recruitment of phagocytes and pro-inflammatory cytokines.
Decreased levels of ascorbic acid.
Increased production of hydrogen peroxide by increasing the expression and activity of spermine oxidase |
Studies have shown antioxidants to prevent the generation of ROS and inhibit the H. pylori induced programmed cell death and thus helps in protecting stomach and intestinal lining. In biochemical assays GutGard™ has shown high Oxygen Radical Absorbance Capacity (ORAC) value in addition to potent antioxidant activity in DPPH (2,2-Diphenyl-1-Picrylhydrazyl) and ABTS [2,2’-azinobis-(3-ethylbenzothiazoline-6-sulfonic acid)] assays. |
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| Trypsin inhibition assay |
Trypsin is a Serine proteinase enzyme found in the digestive system, where it breaks down proteins. There is considerable evidence to suggest that ulcer is mediated by excessive protease activity and there is a US patent on proteinase inhibitors for treatment of GI ulcer. In a biochemical assay GutGard™ has shown potent trypsin inhibition activity. |
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| Nitric oxide (NO) scavenging activity |
NO represents a very attractive therapeutic target with respect to several gastrointestinal disorders. There is considerable evidence that inducible nitric oxide synthase (iNOS) is strongly expressed in several inflammatory conditions in the digestive system and that NO derived from this isoform contributes to tissue injury. Scavengers of NO are a very promising tool in various digestive disorders, and there is a strong possibility that NO scavengers will be used clinically. GutGard™ has shown promising results as NO scavenger. |
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Why GutGard™? 
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