Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus
NCT ID: NCT05343767
Last Updated: 2022-05-03
Study Results
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Basic Information
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COMPLETED
NA
198 participants
INTERVENTIONAL
2018-09-12
2021-05-30
Brief Summary
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Detailed Description
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According to the International Diabetes Federation (IDF), the three main types of Diabetes are Type 1 Diabetes, Type 2 Diabetes and Gestational Diabetes. Type 1 DM, formerly described as "Insulin Dependent Diabetes Mellitus" (IDDM) results from β-cells destruction, usually leading to absolute deficiency of insulin. Type 2 DM formerly described as "Non-Insulin-Dependent Diabetes Mellitus" (NIDDM) results from a progressive insulin secretory defect on the background of insulin resistance. Gestational Diabetes, which appears during pregnancy, is associated with increasing the risk of developing type 2 Diabetes in both mother and child later in life.
Diabetes is a rapidly growing health concern in both developed and developing nations and its prevalence is continuously increasing worldwide. Globally, in 2014, approximately 422 million adults were having diabetes, with type 2 making up about 91%of the cases. In 2015, according to IDF, an estimated 415 million adults were having diabetes along with an estimated 318 million adults with impaired glucose tolerance. Both WHO and IDF predict that by 2030, this number will be doubled. In 2016 the WHO global report on Diabetes stated that the prevalence of Diabetes has increased faster in low- and middle-income countries than in high-income countries.
Type 2 Diabetes is characterized by insulin resistance and/or abnormal insulin secretion, either of which may predominate. It is associated with several metabolic defects such as obesity, hypertension, and dyslipidemia, which contribute to the very high rate of cardiovascular morbidity and mortality.
Medicinal herbs were used to treat a wide range of diseases long time before the birth of conventional medicine systems. The World Health Organization (WHO) has listed 21,000 plant names, which are used for medicinal purposes around the world, so despite the fact that medicinal herbs are at times misconceived as being unscientific, their continual existence proves they are able to be alternatives or complementary to conventional drugs at some point.
Specifically, Ficus deltoidea leaves, Cinnamomum cassia L. powdered Extract and Black seed powdered extract have been used for the treatment of Diabetes Mellitus and other medical conditions for over 2000 years. Ficus deltoidea is an evergreen shrub reaching to 2 meters of height, with whitish grey bark, broadly spoon-shaped to obovate leaves and spherical or round figs. Over the years, it has been used to treat many diseases such as; Diabetes Mellitus, Hypertension, Hyperlipidemia and Gout. Numerous studies were conducted over the past years to assess the safety of Ficus deltoidea, Cinnamomum cassia L. powdered extract and Black seed powdered extract and their efficacy in treating type 2 Diabetes Mellitus.
As the available data on NW Low-Glu efficacy, safety and dosing regimen is not enough, this study will be conducted to compare the hypoglycemic effect of two doses of a herbal medicinal product of ficus and Cinnamomum cassia L. powdered Extract + Black seed powdered extract (NW Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients newly diagnosed with type II diabetes mellitus.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Study duration: 3 months of recruitment and 3 months of treatment. Sample Size: It was planned to enroll 68 patients per arm, 204 in total. Participants were patients between 18 and 65 years of age, newly diagnosed with type II diabetes mellitus and consenting to participate in this study.
Eligible patients were randomized in a 1:1:1 allocation ratio, into one of the three treatment groups, to receive either Metformin or one of the two doses of NW Low-Glu.
TREATMENT
QUADRUPLE
Study Groups
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Control Arm 1 Metformin ( 64 patients)
Metformin 1000 mg tablets were used.
* First Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Second Dose: Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Third Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
A total dose of 2000 mg was administered per day.
Metformin
A total dose of 2000 mg was administered per day.
Experimental Arm 2: Low Dose NW Low-Glu ( 65 patients)
The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows:
* First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
Natural Wellness Low-Glu low dose
The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses
Experimental Arm 3: High Dose NW Low-Glu ( 69 patients)
The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows:
* First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
Natural Wellness Low-Glu high dose
The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses
Interventions
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Natural Wellness Low-Glu low dose
The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses
Natural Wellness Low-Glu high dose
The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses
Metformin
A total dose of 2000 mg was administered per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males and females aged between 18 and 65 years of age.
3. Newly diagnosed with type II diabetes mellitus patients as per the following criteria (FBG ≥ 126 mg/dl) or, 2h- post prandial ≥ 200 mg/dl during OGTT or, HbA1c ≥ 6.5%
4. Anti-diabetic treatment naïve patients.
5. Able and willing to perform SMBG and to complete subject diaries.
Exclusion Criteria
2. Patients with BMI \> 40 Kg/m2 or BMI \< 18.5 Kg/m2.
3. eGFR \<60 mL/min/1.73 m2 (measured by the CKD-EPI equation) 3.
4. History of Positive human immunodeficiency virus, hepatitis B surface antigen (HBsAG), or hepatitis C antibody test.
5. History of type I diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's syndrome or acromegaly.
6. History of diabetic complications such as diabetic ketoacidosis, lactic acidosis or state of hyperosmolar hyperglycemia, diabetic proliferative retinopathy, or severe diabetic neuropathy (requiring treatment with antidepressants or opioids) and history of decompensated diabetes (polyuria, polydipsia, nocturia, fatigue).
7. History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data.
8. History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding.
9. History of an eating disorder (e.g., bulimia, anorexia).
10. History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to screening.
11. History of significant cardiovascular disease (such as congestive heart failure, myocardial infarction, coronary disease) or uncontrolled hypertension.
12. History of clinically significant renal or liver disease.
13. Receipt of an investigational drug within 30 days prior to screening, or active enrollment in another investigational medication or device trial.
14. Known or suspected allergy to the trial products.
15. Any condition, in the judgment of the investigator, that would interfere with the patient's ability to comply with all study requirements or that would place the patient at unacceptable risk by his/her participation in the study.
18 Years
65 Years
ALL
No
Sponsors
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Natural Wellness Egypt
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr Samir Helmy Assaad, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alexandria
Locations
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Natural Welness Egypt
Cairo, Nasr City, Egypt
Countries
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References
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Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008 Nov;88(11):1322-35. doi: 10.2522/ptj.20080008. Epub 2008 Sep 18.
Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
IDF. IDF Diabetes Atlas · Seventh Edition. 2015.
WHO. Global report on diabetes. 2016.
Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
Edelman SV. Type II diabetes mellitus. Adv Intern Med. 1998;43:449-500.
Pan SY, Pan S, Yu ZL, Ma DL, Chen SB, Fong WF, Han YF, Ko KM. New perspectives on innovative drug discovery: an overview. J Pharm Pharm Sci. 2010;13(3):450-71. doi: 10.18433/j39w2g.
Bamosa A, Kaatabi H, Badar A, Al-Khadra A, Al Elq A, Abou-Hozaifa B, Lebda F, Al-Almaie S. Nigella sativa: A potential natural protective agent against cardiac dysfunction in patients with type 2 diabetes mellitus. J Family Community Med. 2015 May-Aug;22(2):88-95. doi: 10.4103/2230-8229.155380.
Jia Q, Liu X, Wu X, Wang R, Hu X, Li Y, Huang C. Hypoglycemic activity of a polyphenolic oligomer-rich extract of Cinnamomum parthenoxylon bark in normal and streptozotocin-induced diabetic rats. Phytomedicine. 2009 Aug;16(8):744-50. doi: 10.1016/j.phymed.2008.12.012. Epub 2009 May 22.
Corner E. The complex of Fixcus Deltoidea ; A recent invasion of the sunda shelf. Philos Trans R Soc London B, Biol Sci. 1969 Nov;256(808):281-317.
Hakiman M, Maziah M. Non enzymatic and enzymatic antioxidant activities in aqueous extract of different Ficus deltoidea accessions. J Med Plants Res. 2009;3(3):120-31.
Sulaiman MR, Hussain MK, Zakaria ZA, Somchit MN, Moin S, Mohamad AS, Israf DA. Evaluation of the antinociceptive activity of Ficus deltoidea aqueous extract. Fitoterapia. 2008 Dec;79(7-8):557-61. doi: 10.1016/j.fitote.2008.06.005. Epub 2008 Jul 10.
Prakash B, Singh P, Yadav S, Singh SC, Dubey NK. Safety profile assessment and efficacy of chemically characterized Cinnamomum glaucescens essential oil against storage fungi, insect, aflatoxin secretion and as antioxidant. Food Chem Toxicol. 2013 Mar;53:160-7. doi: 10.1016/j.fct.2012.11.044. Epub 2012 Dec 5.
Tauseef Sultan M, Butt MS, Anjum FM. Safety assessment of black cumin fixed and essential oil in normal Sprague Dawley rats: Serological and hematological indices. Food Chem Toxicol. 2009 Nov;47(11):2768-75. doi: 10.1016/j.fct.2009.08.011. Epub 2009 Aug 21.
Draman S, Aris M, Razman, SFU A, H A, AR NA, et al. Mas Cotek (Ficus deltoidea): A Possible Supplement for Type II Diabetes: (A Pilot Study). Pertanika J Trop Agric Sci. 2012;35(1):93-102.
Monnier L, Colette C. Target for glycemic control: concentrating on glucose. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S199-204. doi: 10.2337/dc09-S310. No abstract available.
American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S111-S124. doi: 10.2337/dc21-S009.
Handelsman Y, Bloomgarden ZT, Grunberger G, Umpierrez G, Zimmerman RS, Bailey TS, Blonde L, Bray GA, Cohen AJ, Dagogo-Jack S, Davidson JA, Einhorn D, Ganda OP, Garber AJ, Garvey WT, Henry RR, Hirsch IB, Horton ES, Hurley DL, Jellinger PS, Jovanovic L, Lebovitz HE, LeRoith D, Levy P, McGill JB, Mechanick JI, Mestman JH, Moghissi ES, Orzeck EA, Pessah-Pollack R, Rosenblit PD, Vinik AI, Wyne K, Zangeneh F. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY--CLINICAL PRACTICE GUIDELINES FOR DEVELOPING A DIABETES MELLITUS COMPREHENSIVE CARE PLAN--2015--EXECUTIVE SUMMARY. Endocr Pract. 2015 Apr;21(4):413-37. No abstract available.
Bunawan H, Amin NM, Bunawan SN, Baharum SN, Mohd Noor N. Ficus deltoidea Jack: A Review on Its Phytochemical and Pharmacological Importance. Evid Based Complement Alternat Med. 2014;2014:902734. doi: 10.1155/2014/902734. Epub 2014 Mar 18.
Choo CY, Sulong NY, Man F, Wong TW. Vitexin and isovitexin from the Leaves of Ficus deltoidea with in-vivo alpha-glucosidase inhibition. J Ethnopharmacol. 2012 Aug 1;142(3):776-81. doi: 10.1016/j.jep.2012.05.062. Epub 2012 Jun 7.
Adam Z, Khamis S, Ismail A, Hamid M. Ficus deltoidea: A Potential Alternative Medicine for Diabetes Mellitus. Evid Based Complement Alternat Med. 2012;2012:632763. doi: 10.1155/2012/632763. Epub 2012 Jun 3.
Dugoua JJ, Seely D, Perri D, Cooley K, Forelli T, Mills E, Koren G. From type 2 diabetes to antioxidant activity: a systematic review of the safety and efficacy of common and cassia cinnamon bark. Can J Physiol Pharmacol. 2007 Sep;85(9):837-47. doi: 10.1139/Y07-080.
Crawford P. Effectiveness of cinnamon for lowering hemoglobin A1C in patients with type 2 diabetes: a randomized, controlled trial. J Am Board Fam Med. 2009 Sep-Oct;22(5):507-12. doi: 10.3122/jabfm.2009.05.080093.
Akilen R, Tsiami A, Devendra D, Robinson N. Cinnamon in glycaemic control: Systematic review and meta analysis. Clin Nutr. 2012 Oct;31(5):609-15. doi: 10.1016/j.clnu.2012.04.003. Epub 2012 May 12.
Askari G, Rouhani MH, Ghaedi E, Ghavami A, Nouri M, Mohammadi H. Effect of Nigella sativa (black seed) supplementation on glycemic control: A systematic review and meta-analysis of clinical trials. Phytother Res. 2019 May;33(5):1341-1352. doi: 10.1002/ptr.6337. Epub 2019 Mar 14.
Daryabeygi-Khotbehsara R, Golzarand M, Ghaffari MP, Djafarian K. Nigella sativa improves glucose homeostasis and serum lipids in type 2 diabetes: A systematic review and meta-analysis. Complement Ther Med. 2017 Dec;35:6-13. doi: 10.1016/j.ctim.2017.08.016. Epub 2017 Aug 30.
Other Identifiers
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NW_Low-Glu_14122016
Identifier Type: -
Identifier Source: org_study_id
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