In the current scenario, people have often adopted a sedentary lifestyle with a large amount of fast-food consumption, a lack of a balanced and nutritious diet, etc., which is drastically hampering their gut health. So there is an emerging need for a promising and safe medication for gastrointestinal illnesses that promotes improvement of overall gut health. The present clinical trial aims at generating evidence around the safety and effectiveness of incorporating a phytoconstituents-based product in the management of digestive ailments. This clinical trial was a randomized, double-blind, placebo-controlled trial involving 60 patients with selfdescribed gastrointestinal symptoms, divided equally into two parallel groups. Herbal formulation and placebo treatment were given as 1 tablet twice a day after meals for 3 months. Response to treatment was evaluated from the baseline to the end of the study on the basis of changes in symptom scores for various clinical symptoms like epigastric pain, heartburn, nausea, constipation, etc. Also, the safety and tolerability of the drug were evaluated by monitoring adverse events and hematological, lipid, liver, and renal function tests at baseline and the end of the study. 100% of patients got relief from symptoms like epigastric discomfort, belching, flatulence, fullness of the stomach, abdominal distension, hyperacidity, bloating, and postprandial fullness in 14 days of treatment with herbal formulation. 100% of patients got relief from heartburn, nausea, and vomiting in 7 days of treatment with herbal formulation. Also, 100% of patients got relief from constipation after 90 days of treatment of herbal formulation. There was reduction in rescue medication for 90% of subjects after 90 days of treatment of herbal formulation. While there was no evidence of fluctuation in liver function test, renal function test and lipid profile indicating systemic safety. Therefore, indicating improvement in overall health and quality of life of patients with gastrointestinal discomfort as compared to the placebo treatment.
Introduction: Ayurvedic medications are extensively used across the world for illness prevention and treatment. The components found in the Coroprotect tablet are Ashwagandha ext., Suddhashilajit ext., Giloyext., Dadim ext., Haridra ext., Saragavo ext., Brahmi ext., Papaya ext., Methiext., Punarnava ext., Kalmegh ext.etc. all are found to be safe and used in Ayurvedic system since many years. Objective: In Rodents, acute and subacute toxicity of coroprotect tablet was studied after a single and repeated 28-day oral dosage administration. Method: In acute toxicity testing, 2000 mg/kg single dose of coroprotect tablet have been employed, whereas doses of 100, 200, 400mg/kg have been utilized in subacute toxicity testing over a 28-day period in rodents. Result: With coroprotect tablet administration, no treatment-related fatalities or toxic signshave been identified in an acute toxicity investigation. There have been no significant variations in body weight changes, water/food intake, haematology, or clinical biochemistry content among the control and coroprotect tablet groups in the repeated dosage research. Between the control and coroprotect pill groups, no gross pathological abnormalities or differences in relative organ weights were found. With coroprotect tablet therapy, histopathological investigation indicated no abnormalities. Conclusion: In a repeated dosage toxicity study in rodents, the coroprotect tablet was determined to be safe at all dose levels.
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