EVAULATION OF CLINICAL STUDY ON POLY PHYTO HERBAL FORMULATION

CLINICAL EVALUATION OF A DRUG OF POLY HERBAL PHYTO FORMULATION IN GASTRO INTESTINAL DISORDER BY Dr. S.N Sharma & Mr. Niraj Kumar Akums Drugs & Pharmaceuticals Ltd, Haridwar Correspondence Author Dr Surendra Nath Sharma Head R&D (Ayush) Akums Drugs & Pharmaceuticals Ltd Key Words Hyper Acidity, Dudenal Ulcer, Peptic Ulcer, Gastro Intestinal Abstract : Hyper Acidity is mainly caused by excessive secretion of gastric acid in Stomach. This Condition is treated by the Application of Antacid. The mentioned Poly Herbal Formulation of ACICUT containing 6 & 7 ingredients. Which is in form of Tablet, EVT, & Syrup. But we are focusing upon Tablet. Here in the present study of Physicochemical & Phytochemical investigation carried out to insurethe use of only uniform & genuine herb materials. In preparation of this poly hobal formulationto standardize them & their in vitro acid neutralizing capacity was carrid out to check out the potency of poly herbal Formulation compared with other well known Antacid Formulation study showed that all the physicochemical parametres werecomplied the standard limit. Phytochemical investgation showed that presence of various constituency those might be responsible for the Acid neutralizing capacity of poly herbal Formulation comparable with other well know Antacid INTRODUCTION : The term Hyper acidity or Acidity is commonly applied to unsartisfactory condition of Stomach.In this conditionit is use to denote both a group of clinical & chemical symptoms anomaly, There is no further definite understanding as to the ammount of acid necessary to create a hyper acid state. The Stomach Normally secreat acid is essential for digestion of food but, When there is an excess production of Acid it result in the condition known as hyper Acidity, Heart burn, Dyspepsia, Eructation & Flatulency are the common symptoms of Acidity. Antacid provide a Smptomatic relief from these symptoms. Antacid are theagent which react with gastric acid to neutralize it & lower the acidity of gastric contents, Acid neutralizing capacity of an Antacid represented the ability of itsto absorb acid produced by stomachwhile holding pH above specific value. In spite of the presence of defferent known Antacid present in the Market. The drugs obtained from plant kingdom may provide use full source of new Antacid compounds for the development on newer Formulation. The present moto of this study was to invesigate the physicochemical & phytochemical parametre in order to standardize & Evaluate in vitro acidneutralizing capacity of polyherbal Formulation compared with other known Antacid present in the market which is all ready in use but least potent, ACICUT a Herbal Formulation of Akums Drugs & Pharmaceuticals Ltd consit one main content of Glycerrhiza glabra (Glycyrrhizin) which is all ready having provedactivity against Ulcer & as an Antioxidant .ACICUT also capable to heal the injuri to the gastroduodenal due to presence of the Vital herbal contents. ACICUT is very promising drug against Non ulcer Dyspepsia (NUD).The pathophysiology of this condition hasbeen poorly characterized and its opimum treatment is uncertain but in this ailment this drug is also proved The ACICUT Formulation is clinically trilled n the volunteer who had been suffering from chronic infection Tape worm & Round worm that consequentely lead him weaker & weaker. The intake of this drug made him free from these prior infection of chronic causes are infection with bacteria like Helecobacter pylori, Certen diseases such as pernicious anaemia, chronic bile reflux stress and Auto immune disordercan be cured by the application of ACICUT Content. The main content oif ACICUT of Glycerrhiza glabra whose main active ingredient is Glycyrrhizin in (Fig-1) Glycyrrhizin is a Triterpine glycoside, It is extracted from the Root of Glycerriza. The Glycyrrizin sweet in nature and is used to cure defferent GI Ailments.. Fig-1 ( Glycyrrhizin ) MATERIAL OF METHODS : The main contents of poly herbal medicine ACICUT is Glycerrhyza glabra which is use full in Detoxyfication of Liver and protect by Liver. It is beenUsed in Mouth Ulcer & Arthrities. The acicut is alreadt tested On the patient suffering from Peptic ulcer Arthrities, Swelling Of tomy and alaergic complaint.As Conclusion it is found that ACICUT is used to treat a variity Of ailment and is effective for the tratment of cough. PepticUlcer, arthrituies and inflamation of tomy A Clinical study was under taken in the R&D Deppt.of AkumsDrugs & Pharmaceuticals Ltd, Haridwar.12 patients were Recruited forthe defferent plant accordingto their respectiveailiment And consent. Out of them one is Female and rest are male. Or the patient Were of defferent age group and with different associated symptoms like Epigastritic dyscomfort ,Hert burn, Belching, Flatulance,& fullness of Abdomen and arthrities. During the trial period and on evaulation after 3 weeks the relief in Symptoms was quite significant, as reported by most patients. Epigastritis Discomfort and Heart burn were in recieved in 9 patients. Other associate symptoms were also significantly lowered . Especially one or two patients Abdominal fullness and diziness was significantly relieved.The details of The results are shown in the Following Table-1 Table1: Clinical Features Symptoms Male % Female % Heart Burn 9 99 2 97 Fullness stomach 5 76 1 75 Epigastric 9 87 1 80 Nausea 6 72 2 90 Vomit 4 68 2 86 Flatulance 3 55 1 72 Belching 2 90 1 75 Migrain 3 75 2 65 Table 2: Effect of ACICUT Symptoms Male % Female % Heart Burn 9 95 2 85 Fullness stomach 5 76 1 70 Epigastric 9 85 1 70 Nausea 6 72 2 90 Vomit 4 68 2 86 Flatulance 3 55 1 72 Belching 2 85 1 73 Migrain 3 68 2 60RESULTS & DISCUSSION One miraculus result of ACICUT was seenThat disease symptom not apeared at all after2-3 week discontinued the cource of ACICUT. The Syrup/Tablet both provided the patients Substantial relief for a longer duration. The ACICUT can be attributable to the Antacid as well as Anti Ulcer Effects. The principal content of ACICUT, glycerrhiza glabra its Anti Ulcer activity has been demostrated both experimently and clinically. Intraperitonial, Intra duodenal or oral administration of Aqueous or Alcoholic extracts of glycerrhiza glabra has been shown to reduce gastric secreation in a Rats, Inhabiting the formation of gastric ulcers induced by pyloric ligation. Glycerrhiza have anti phlogistic activity an increased the rate of mucus secreation by gastric mucosa. The mechanism of Anti Ulcer activity involves Acceleration of mucain excretion through increasing the synthesis of glyco protien in the gastric Mucosa, Prolonging the life of the epithelial cells and Anti pepsin activety .Acid-related diseases, such as gastroesophageal refluxdisease (GERD), have significant impact on healthcare. As a result, healthcare providers must deviseways to limit expenditure while providing high-quality patient care. Although the goals of therapy are the same in both traditional and managed care environments, optimal costcontaainmen strategies depend heavily on the specifics of payment and risk arrangements involved. Cost-saving strategies involving drug therapy are often based On the assumption that treatments with lower acquisition costs are the most cost effective. In case of gastritis treatment, the efficacy of acidsupprressio therapies should also be considered. In addition, efficacy should be a major consideration in therapy choice because recurrence and complications as a result of ineffective therapies can negatively affect the patients’ quality of life and increase the overall cost of healthcare. Studies have shown that people who had received at least one prescription of cimetidine, famotidine, nizatidine, ranitidine, lansoprazole or omeprazole acid-suppressing drugs, had a substantial increase in risk of developing pancreatitis. We took up the study of ACICUT as it is a safe herbomineral One miraculus result of ACICUT was seenThat disease symptom not apeared at all after2-3 week discontinued the cource of ACICUT. The Syrup/Tablet both provided the patients Substantial relief for a longer duration. The ACICUT can be attributable to the Antacid as well as Anti Ulcer Effects. The principal content of ACICUT, glycerrhiza glabra its Anti Ulcer activity has been demostrated both experimently and clinically. Intraperitonial, Intra duodenal or oral administration of Aqueous or Alcoholic extracts of glycerrhiza glabra has been shown to reduce gastric secreation in a Rats, Inhabiting the formation of gastric ulcers induced by pyl;oric ligation. Glycerrhiza have anti phlogistic activity an increased the rate of mucus secreation by gastric mucosa. The mechanism of Anti Ulcer activity involves Acceleration of mucain excretion through increasing the synthesis of glyco protien in the gastric Mucosa, Prolonging the life of the epithelial cells and Anti pepsin activety .preparation. ACICUT is a Syrup/Tablet comprising of Glycerrhizin a which is a active ingredients from glycerrhiza glabra ACICUT has proved to be an effective and well tolerated drugin the management of gastritis, heartburn and acid peptic disease. It has a high standard of efficacy and safety in both gastritis and in ulcer therapy and provides good symptomatic relief in all patients. Few patients were given H. pylori eradication treatment in whom H pylori infections were detected. In NSAIDs related gastritis and ulcers withdrawal of the drug and antacid suspension gave good result. CONCLUSION Thus, it can be concluded that ACICUT is effective in relieving symptoms of gastritis and acid peptic disease. Pain relief was considerate in the first two weeks itself. No patients complained of any adverse events. ACICUT could become the mainstay in the management of gastritis and acid peptic disease.