Investigation into the molecular mechanism of action of Triticum aestivum for its activity in Thalassemia

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1 Investigation into the molecular mechanism of action of Triticum aestivum for its activity in Thalassemia Clinical study: The clinical study Investigation into the molecular mechanism of action of Triticum aestivum for its activity in Thalassemia was conducted at Sir. Takhtasinhji Hospital, Bhavnagar. The necessary permission of institutional review board Government medical college Bhavnagar was obtained by letter no. IRB (HEC) no.19/2008 dated 07/09/2009 prior to the commencement of clinical study. The permission letter is attached on the last page of the thesis. The Clinical study was prospective, open labelled, non-randomised, parallel design and no controlled neutraceuticals clinical trial on thalassemia major patients. The clinical trial was carried out from April to March The informed consent form in Gujarati language was taken from all the patients/parents or their relatives. Inclusion criteria: The study included a total of 28 thalassemia major patient s age range from 2 to 25 years registered indoor patients for the blood transfusion at Sir.T hospital, Bhavnagar and they were divided into 2 groups. Out of 22 patients 16 patients were with spleen and 6 patients were without spleen. Thalesemia major patients were selected and they were administered Green Era Wheat Grass capsules each containing 320 mg. of wheatgrass (Triticum aestivum) dry powder received from Green Era foods and Nutraceutics, Bhavnagar.

2 Summary and Conclusions : 1. Administration of wheatgrass capsules or juice for 9 months in patients with thalassemia major produced increase in mean cell volume (MCV) and elevated in value of mean cell haemoglobin concentration (MCHC). However, no significant changes were observed in red blood cells (RBCs), packed cell volume (PCV), mean cell haemoglobin (MCH) and red cell distribution width (RDW) in thalassemia major patients. 2. Treatment with wheatgrass capsules for 9 months produced increase in level of haemoglobin (Hb) however, increase in haemoglobin (Hb) was not found with wheatgrass juice. 3. Both wheatgrass capsules as well as juice produced significant increase in mean blood transfusion interval in thalassemia major patients. 4. Wheatgrass juice and not the capsules induce foetal haemoglobin (HbF) level in thalassemia major patients and hence the effect of wheatgrass on HbF requires further investigations however, both wheatgrass capsules and juice after 9 months treatment produced decrease in HbA 2 level in thalassemia major patients. 5. Administration of wheatgrass capsules produced anti allergic properties by virtue of decrease in eosinophil count in thalassemia major patients however, decrease in eosinophil counts was not found with wheatgrass juice. 6. Treatment with wheatgrass capsules and juice for 9 months, we did not observed major changes in total WBC count, neutrophil count, lymphocyte count, monocyte count and hence, wheatgrass does not produce any adverse effect on defense mechanisms of body in patients with thalassemia.

3 7. Wheatgrass capsules produced decrease in SGPT and SGOT level by virtue of various antioxidants and hence, it appears to possess hepato-protective property. produced contradictory results after 6 and 9 months treatment period so it requires further investigations. 8. Serum creatinine and blood urea nitrogen (BUN) level remains unaffected either before treatment or after treatment with wheatgrass capsules or juice. 9. Administration of wheatgrass capsules or juice for 9 months period produced reduction in serum ferritin, serum iron, and total iron binding capacity (TIBC) indicates that wheatgrass reduces iron over load in thalassemia major patients. 10. The urine analysis produced excretion of urobilinogen in normal level and absence of bilirubin, bile salts, leukocytes, nitrites, protein, and glucose in pre and post treated thalassemia major patients. These results indicated that iron is not excreted in abnormal proportion through kidney in thalassemia major patients. 11.Both wheatgrass capsules and juice produced positive chromo azurol S (CAS) assay for the presence of phytosiderophore (mugienic acid). 12. In vitro assay of Iodometric titration supported the presence of phytosiderophore by showing iron complexation in ferric ammonium sulphate treated with wheatgrass capsules or juice as compared to that of un-treated ferric ammonium sulphate. 13. The colorimeter assay of ferric ammonium sulphate plus potassium thiocynate treated with wheatgrass capsules or juice produced decrease in absorbance as compared to untreated ferric ammonium sulphate.

4 14. Treatment with wheatgrass capsules or juice, thalassemia major patients were not getting frequent infections, cold and cough. Treatment with wheatgrass in patients was not found to produce any adverse effects or enlargement of abdomen during entire period of study. Conclusions: We conclude that wheatgrass capsules produced increase in mean cell volume (MCV) and mean cell haemoglobin concentration (MCHC) level, significant elevation in mean blood transfusion interval, reduction in HbA 2 level in thalassemia major patients. Treatment with Green Era Wheat Grass capsules produced increase in haemoglobin level and anti-allergic properties in thalassemia major patients, however, increase in haemoglobin level and an anti-allergic property was not found with wheatgrass juice. Both wheatgrass capsules and juice does not produce any adverse effect on defense mechanisms of body in thalassemia major patients. We also conclude that treatment with wheatgrass capsules possess hepato-protective action by virtue of exogenous antioxidants however; hepato-protective action was not found with wheatgrass juice in thalassemia major patients. Both wheatgrass capsules and juice produced decrease in iron over load in patients with thalassemia and hence, improves the quality of life in thalassemics. In conclusion, our studies suggest the potential benefit of Green Era Wheat Grass capsules as well as juice by virtue of its multiple beneficial therapeutic actions in thalassemia and its associated complications we recommend wheatgrass as a good option in the treatment of thalassemia major.

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