Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy
NCT ID: NCT06131918
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2023-01-09
2024-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Resveratrol+ Alpha lipoic acid +Superoxide dismutase
This group will receive Resveratrol 1500 mg BD Tab Alpha lipoic acid 600 mg BD Tab Superoxide dismutase 250 mg BD
Resveratrol, Alpha lipoic acid, Super oxide dismutase
Tab Resveratrol 1500 mg BD Tab Alpha lipoic Acid 600 mg BD Tab Superoxide dismutase 250 mg BD
Resveratrol
This group will receive Tab Resveratrol 1500 mg BD
Resveratrol
Tab Resveratrol 1500 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
Alpha lipoic Acid
This group will receive Tab Alpha lipoic acid 600mg BD
Alpha lipoic acid
Tab Alpha lipoic acid 600 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
Superoxide dismutase
This group will receive Tab Superoxide dismutase 250mg BD
Super Oxide Dismutase
Tab Super oxide dismutase 250 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
Interventions
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Resveratrol, Alpha lipoic acid, Super oxide dismutase
Tab Resveratrol 1500 mg BD Tab Alpha lipoic Acid 600 mg BD Tab Superoxide dismutase 250 mg BD
Resveratrol
Tab Resveratrol 1500 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
Alpha lipoic acid
Tab Alpha lipoic acid 600 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
Super Oxide Dismutase
Tab Super oxide dismutase 250 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 40-60 years
Exclusion Criteria
* Vitamin B12 deficiency
* History of drug or alcohol abuse
* Taking antioxidant treatment
* History and baseline investigations for renal hepatic and haematological diseases
* Pregnant or lactating women.
40 Years
60 Years
ALL
No
Sponsors
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Khyber Medical University Peshawar
OTHER
Responsible Party
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Principal Investigators
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Syed Hamid Habib, PhD
Role: STUDY_DIRECTOR
Khyber Medical University
Locations
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Syed Hamid Habib
Peshawar, KPK, Pakistan
Countries
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References
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Jiang B, Guo L, Li BY, Zhen JH, Song J, Peng T, Yang XD, Hu Z, Gao HQ. Resveratrol attenuates early diabetic nephropathy by down-regulating glutathione s-transferases Mu in diabetic rats. J Med Food. 2013 Jun;16(6):481-6. doi: 10.1089/jmf.2012.2686.
Bhatt JK, Thomas S, Nanjan MJ. Resveratrol supplementation improves glycemic control in type 2 diabetes mellitus. Nutr Res. 2012 Jul;32(7):537-41. doi: 10.1016/j.nutres.2012.06.003. Epub 2012 Jul 27.
Kennedy DO, Wightman EL, Reay JL, Lietz G, Okello EJ, Wilde A, Haskell CF. Effects of resveratrol on cerebral blood flow variables and cognitive performance in humans: a double-blind, placebo-controlled, crossover investigation. Am J Clin Nutr. 2010 Jun;91(6):1590-7. doi: 10.3945/ajcn.2009.28641. Epub 2010 Mar 31.
Szkudelski T, Szkudelska K. Resveratrol and diabetes: from animal to human studies. Biochim Biophys Acta. 2015 Jun;1852(6):1145-54. doi: 10.1016/j.bbadis.2014.10.013. Epub 2014 Oct 27.
Bjornholm M, Zierath JR. Insulin signal transduction in human skeletal muscle: identifying the defects in Type II diabetes. Biochem Soc Trans. 2005 Apr;33(Pt 2):354-7. doi: 10.1042/BST0330354.
Villegas-Rivera G, Roman-Pintos LM, Cardona-Munoz EG, Arias-Carvajal O, Rodriguez-Carrizalez AD, Troyo-Sanroman R, Pacheco-Moises FP, Moreno-Ulloa A, Miranda-Diaz AG. Effects of Ezetimibe/Simvastatin and Rosuvastatin on Oxidative Stress in Diabetic Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Oxid Med Cell Longev. 2015;2015:756294. doi: 10.1155/2015/756294. Epub 2015 Jul 28.
Oyenihi AB, Ayeleso AO, Mukwevho E, Masola B. Antioxidant strategies in the management of diabetic neuropathy. Biomed Res Int. 2015;2015:515042. doi: 10.1155/2015/515042. Epub 2015 Mar 2.
Kumar A, Kaundal RK, Iyer S, Sharma SS. Effects of resveratrol on nerve functions, oxidative stress and DNA fragmentation in experimental diabetic neuropathy. Life Sci. 2007 Mar 6;80(13):1236-44. doi: 10.1016/j.lfs.2006.12.036. Epub 2007 Jan 20.
Xiao WH, Bennett GJ. Effects of mitochondrial poisons on the neuropathic pain produced by the chemotherapeutic agents, paclitaxel and oxaliplatin. Pain. 2012 Mar;153(3):704-709. doi: 10.1016/j.pain.2011.12.011. Epub 2012 Jan 13.
Pham-Huy LA, He H, Pham-Huy C. Free radicals, antioxidants in disease and health. Int J Biomed Sci. 2008 Jun;4(2):89-96.
Valko M, Leibfritz D, Moncol J, Cronin MT, Mazur M, Telser J. Free radicals and antioxidants in normal physiological functions and human disease. Int J Biochem Cell Biol. 2007;39(1):44-84. doi: 10.1016/j.biocel.2006.07.001. Epub 2006 Aug 4.
Rahimi-Madiseh M, Malekpour-Tehrani A, Bahmani M, Rafieian-Kopaei M. The research and development on the antioxidants in prevention of diabetic complications. Asian Pac J Trop Med. 2016 Sep;9(9):825-831. doi: 10.1016/j.apjtm.2016.07.001. Epub 2016 Aug 5.
Other Identifiers
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HAMIDHABIB
Identifier Type: -
Identifier Source: org_study_id
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