Abstract
Background and objectives: Diabetes is a common metabolic disorder.Type 2 diabetes accounts for the vast majority of around 92% of the population worldwide. Long term hyperglycemia leads to macro and microvascular complications. Oxy+ is a nutraceutical capsule which contains mainly Arthrospira (spirulina). Most of the diabetic people use it. Hence a clinical trial was conducted to evaluate the clinical efficacy and safety of Oxy + in Type 2 Diabetes.Material Methods: The study was designed as a single-blind pilot study; 10 eligible patients of type 2 diabetes were allocated. Oxy+ was given in capsule form; 2 capsules twice daily orally for 45 days after the meal. Test drug was evaluated on subjective parameters at 0th, 15th, 30th and 45th days whereas objective parameters were assessed before and after the treatment. The results of the intervention were analyzed using suitable statistical methods.Results and Observation:The study effects on subjective parameters like polyuria, tiredness, polyphagia, polydipsia, and Tingling Sensation were found significantly reduced. The objective parameters were assessed before and after as Mean ± SD for FBS (164.4±36.019 vs 111.1±25.075), PPBS (248.5±51.70 vs 170.1±45.148) and HbA1c (9.14±1.517 vs 6.95±1.224).The results were analyzed after using paired‘t’ test.Interpretation and Conclusion:The findings about both parameters (subjective and objective) that the ‘Oxy+’ is effective in type 2 diabetes and the cure was considerable. Safety parameters (SGOT, SGPT, Blood Urea, and Serum Creatinine) were remained unchanged. Therefore, it can be concluded that the ‘Oxy+’ would be safe and effective in the management of type 2 diabetes.International Journal of Human and Health Sciences Vol. 05 No. 01 January’21 Page: 96-100
Highlights
Oxy+ is a natural source of oxygen found in nature and used as a dietary supplement and manufactured in Aruba for lifefactors.18It is a richest source of Arthrospira[19,20] and which have been reported to be an antioxidant, immuno-modulator, hypoglycemic, anti-dyslipidemic, hepatoprotective, antiviral and anticancer activities.21,22Previous pre-clinical,[23] and clinical studies have shown that Arthrospira and its active ingredients can reveal anti-diabetes properties.[24,25,26,27]
This interpretation led us to substantiate the hypoglycemic activity of Research Drug among diagnosed cases of type 2 diabetes
Inclusion criteria included the diagnosed cases of type 2 DM with Fasting Blood Sugar>126 mg/dl; Postprandial Blood Sugar>200 mg/dl, HbA1c>6.5%, and aged between 30-60 years of both gender, patients willing to participate in the study and ready to follow the instructions.24,28Exclusion criteria included pregnant and lactating mother and other complications of diabetes. 2.2 Study Design: Eligible patients with type 2 diabetes were enrolled to participate in this study
Summary
Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action, or both.1Diabetes mellitus (DM) is probably one of the oldest diseases known to mankind and it was first reported in Egyptian manuscript about 3000 years ago.2Type 2 diabetes accounts for the vast majority around 92% of diabetes worldwide.3According to IDF (International Diabetes Federation) Atlas 9th edition 2019 worldwide prevalence of Diabetes is 463 million and it is expected to be 700 million in the year of 2045.4The estimated global direct health expenditure on diabetes in 2019 is USD 760 billion and is expected to grow to a projected USD 825 billion by 2030 and USD 845 billion by 2045.5The main cause is poor glycaemic control which leads to microvascular(Diabetic nephropathy, neuropathy, and retinopathy),[6] and macrovascular (Coronary artery disease, peripheral arterial disease, and stroke) complications.7Diabetes can be controlled effectively by reducing overweight and by taking a balanced lifestyle (diet and physical activity) in combination with medication when needed.8,9Biguanides,[11] sulfonylureas,[12] thiazolidinediones, α-glucosidase inhibitors, sodium-glucose co-transporter inhibitors,13meglitinides, incretins, DPP-4 inhibitors and hormone analoges are commonly used for the treatment of this debilitating disease.14,15Long term use of the above-mentioned medications leads to a multitude of complications; hypoglycemia, renal issues, heart problems and GIT disorders.[16,17]. Oxy+ is a natural source of oxygen found in nature and used as a dietary supplement and manufactured in Aruba for lifefactors.18It is a richest source of Arthrospira (spirulina) (contain phycocyanin, sulfated polysaccharides, γ-linoleic acid, carotene, iron etc.)[19,20] and which have been reported to be an antioxidant, immuno-modulator, hypoglycemic, anti-dyslipidemic, hepatoprotective, antiviral and anticancer activities.21,22Previous pre-clinical,[23] and clinical studies have shown that Arthrospira (spirulina) and its active ingredients can reveal anti-diabetes properties.[24,25,26,27] This interpretation led us to substantiate the hypoglycemic activity of Research Drug among diagnosed cases of type 2 diabetes. A study was contemplated to evaluate the clinical efficacy and safety of Research Drug (Oxy+) in type 2 Diabetes
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: International Journal of Human and Health Sciences (IJHHS)
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
