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Devale, Milind
- Effect of a Novel Phytopharmaceutical Formulation with an Innovative Potential in Patients with Treated Uncontrolled Type 2 Diabetes Mellitus
Authors
1 Proprietor, Shreepad Shree Vallabh, SSV Phytopharmaceuticals, Mumbai, Maharashtra, India., IN
2 Consulting Physician, Kokan Hospital, Mumbai, Maharashtra, India., IN
Source
The Indian Practitioner, Vol 75, No 4 (2022), Pagination: 21-27Abstract
Background and Aims: Diabetes mellitus is a major health problem in India. The development of a new drug of natural origin that assures safety with moderate but definite efficacy is the need of the time. Authors have developed formulation containing phytoactives from Pterocarpus marsupium Roxb and Andrographis paniculata Nees in specific proportion for the first time, as an anti-diabetic supplement which improves the glycemic control. We aim to study the effect of PtyroneTM in patients with treated uncontrolled T2DM and its safety and tolerability.
Study Design: In an open labelled trial, 115 patients with T2DM were divided in three groups: Metformin, Metformin + Gliptins and Metformin + Sulphonylurea. PtyroneTM capsules were given to all the patients along with their OHA’s, orally twice a day for 12 weeks. Laboratory investigations were studied at the baseline and at fixed intervals till the end of the study.
Results: There was a statistically significant decrease (p value< 0.0001) in fasting and post prandial blood sugar along with triglycerides in all groups. There was reduction in levels of glycosylated haemoglobin also in all the groups. All other biochemical investigations were within normal limits. PtyroneTM capsules were well tolerated clinically and no serious adverse events were reported during the period of therapy.
Conclusion: The authors have shown, for the first time, the therapeutic potential of PtyroneTM at a dose of 450 mg twice a day supplemented along with anti-diabetic medications. This therapeutic efficacy needs to be evaluated further in a larger sample size, with a placebo/active controlled randomized double blind multicentric trial
Keywords
Treated uncontrolled type 2 diabetes mellitus, andrographolide, Pterostilbene, blood sugar, lipids.Full Text
References
- International Diabetes Federation. IDF Diabetes Atlas, 10th edn. Brussels, Belgium: International Diabetes Federatio; 2021.
- Pradeepa R, Deepa R, Mohan V.Epidemiology of diabetes in India- current perspective and future projections. J Indian Med Assoc. 2002 Mar;100(3):144-8.
- Vaidya ADB, Devasagayam TPA. Current status of herbal drugs in India: An overview. J Clin Biochem Nutr. 2007;41:111.
- Vaidya AB, Vaidya R A, Shah SJ, Nabar N S, Subrato Sarkar. Current Status of Indigenous Drugs and Alternative Medicine in Management of Diabetes mellitus. In: RSSDI Text book of Diabetes Mellitus. Hyderabad; 2008.
- Vaidya AB, Antarkar DS, Joshi BS. Traditional Remedies for diabetes Mellitus: Trails, Trials and Trilateral Quest. Diabetes Bulletin 1989;186-191.
- Ertek S, Cetinkalp S. Is There U Turn From Insulin Back to Pills in Diabetes? Curr Vasc Pharmacol. 2014;12(4):617-626
- Panicker GK, Karnad DR, Salvi V, Kothari S. Cardiovascular risk of oral antidiabetic drugs: current evidence and regulatory requirements for new drugs. J Assoc Physicians India. 2012;60:56-61.
- Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S, et al. Systematic Review: Comparative Effectiveness and Safety of Oral Medications for Type 2 Diabetes Mellitus.
- Annals of Internal Medicine. 2007;147:386.
- Muraglitazar Briefing Document, Safety Endocrine and Metabolic Drugs Advisory Committee Meeting. In FDA report of September 9, 2005.
- Raghavan V, Lahiri A, SK A, Goswami U, Gupta CN, Sen S.Effect of teneligliptin vs metformin on glycemic control in Indian patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus: a 12-week randomized comparative clinical study. Int J Adv Med. 2019 Apr;6(2):481-488.
- Nishanth T,Maheswari CU, Lakshmi RS, Sri D, Goud P, Tabassum K. A Study to compare efficacy of metforminglimepiride versus metformin-teneligliptin in type ii diabetic patients. IJPSR, 2018;9(12):5258-5264.
- Devarajan TV, Venkataraman S, Kandasamy N, Oomman A, Boorugu HK, Karuppiah S, et al. Comparative evaluation of safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus: Indian multicentric randomized trial - START Study. Indian J Endocr Metab. 2017;21:745-50.
- Jung M, Park M, Lee HC, Kang YH, Kang ES, Kim SK. Antidiabetic agents from medicinal plants. Current Medicinal Chemistry. 2006;13(10):1203-1218.
- Joshi MC, Dorababu M, Prabha T, Kumar MM, Goel RK.Effects of Pterocarpus marsupium on NIDDM-induced rat gastric ulceration and mucosal offensive and defensive factors. Indian Journal of Pharmacology. 2004;36(5):296.
- Karto. Tingkat manfaat, keamanan, dan efektivitas tanaman obat dan obat tradisional. Karanganyar, Balai Besar Penelitian dan Pengembangan Tanaman Obat dan Obat Tradisional (B2P2TO-OT). Badan Penelitian dan Pengembangan Kesehatan Departemen Kesehatan RI; 2008.pp. 5-13.
- Ahmad I, Aqil F, Owais M. Modern phytomedicine: Turning medicinal plants into drugs. Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA; 2006p.273.
- Komalasari T, Harimurti S. A Review on the Anti-diabetic Activity of Andrographis paniculata (Burm. f.) Nees based in-vivo study. IJPHS 2015;4(4):256-263.
- Perera HKI. Antidiabetic Effects of Pterocarpus marsupium (Gammalu). EJMP.2016;13(4):1-14.
- ModakM, DixitP, LondheJ, GhaskadbiS, Thomas Paul A.Devasagayam. Indian Herbs and Herbal Drugs Used for the Treatment of Diabetes. J. Clin. Biochem. Nutr.2007; 40:163– 173.
- Jin L, Fang W, Li B, Shi G, Li X, Yang Y et al. Inhibitory effect of andrographolide in 3T3-L1 adipocytes differentiation through the PPARγ pathway. Mol Cell Endocrinol.2012;358:81-7.
- Chen CC, Chuang WT, Lin AH, Tsai CW, Huang CS, Chen YT, et al. Andrographolide inhibits adipogenesis of 3T3-L1 cells by suppressing C/EBPβ expression and activation. Toxicol Appl Pharmacol 2016;307:115-22.
- Yang Y, Yan H, Jing M, Zhang Z, Zhang G, Sun Y, et al.Andrographolide derivative AL-1 ameliorates TNBSinduced colitis in mice: involvement of NF-кB and PPAR-γ signaling pathways. Sci Rep. 2016;6:29716.
- Yu BC, Hung CR, Chen WC, Cheng JT. Antihyperglycemic effect of andrographolide in streptozotocin-induced diabetic rats. Planta Med. 2003;69(12): 1075-9.
- Zhang Z1, Jiang J, Yu P, Zeng X, Larrick JW, Wang Y. Hypoglycemic and beta cell protective effects of andrographolide analogue for diabetes treatment. J Transl Med.2009;7:62.
- Aguirre L, Milton-Laskibar I, Hijona E, Bujanda L, Rimando AM, Portillo MP. Effects of pterostilbene in brown adipose tissue from obese rats. J Physiol Biochem. 2016; 73:457-64.
- Gomez-Zorita S, Fernández-Quintela A, Aguirre L, Macarulla MT, Rimando AM, Portillo MP. Pterostilbene improves glycaemic control in rats fed an obesogenic diet: involvement of skeletal muscle and liver. Food Funct.2015;6:1968-76.
- Rimando AM, Nagmani R, Feller DR, Yokoyama W. Pterostilbene, a new agonist for the peroxisome proliferator-activated receptor alpha-isoform, lowers plasma lipoproteins and cholesterol in hypercholesterolemic hamsters. J Agric Food Chem. 2005;53:3403-7.
- Dound YA, Chaudhary S, Rawat S, Alqarni MG, Ahmad MM, Geesi MH and Alam P. Novel Mechanistic Understanding of PtyroneTM: A Plant based Natural Anti-Diabetic Product. Journal of King Saud University - Science 2021;33(5):101454.