Generic placeholder image

Endocrine, Metabolic & Immune Disorders - Drug Targets

Editor-in-Chief

ISSN (Print): 1871-5303
ISSN (Online): 2212-3873

Clinical Trial

A Randomized Controlled Trial of a Herbal Compound for Improving Metabolic Parameters in Diabetic Patients with Uncontrolled Dyslipidemia

Author(s): Ahmad Ghorbani, Mahdi Zarvandi and Hassan Rakhshandeh*

Volume 19, Issue 7, 2019

Page: [1075 - 1082] Pages: 8

DOI: 10.2174/1871530319666190206213420

Price: $65

Abstract

Objective: The aim of this randomized controlled trial was to investigate the effects of a polyherbal compound consisting of Aloe vera, black seed, fenugreek, garlic, milk thistle, and psyllium on diabetic patients with uncontrolled dyslipidemia.

Methods: Fifty patients with type 2 diabetes who had dyslipidemia in spite of statin therapy were randomly allocated to two groups: control group (n = 25) receiving a conventional therapy with hypolipidemic and hypoglycemic drugs and intervention group (n = 25) receiving both the conventional therapy and the herbal compound (one sachet twice daily) for 12 weeks. Each sachet contained 300 mg of Aloe vera leaf gel, 1.8 g of black seed, 300 mg of garlic, 2.5 g of fenugreek seed, 1 g of psyllium seed, and 500 mg of milk thistle seed.

Results: The levels of serum triglyceride, total cholesterol, low-density lipoprotein, and HbA1c showed a significant in-group improvement in the intervention group. However, the effects of the herbal compound on fasting blood glucose remained insignificant. The compound had no unwanted effect on the kidney function parameters (urea, creatinine) and serum liver enzymes (alanine aminotransferase and aspartate transaminase).

Conclusion: The tested herbal compound, as an add-on to statin therapy, was effective in lowering the serum lipids in diabetic patients with uncontrolled dyslipidemia.

Keywords: Aloe vera, diabetes, dyslipidemia, garlic, milk thistle, triglyceride.

Graphical Abstract
[1]
Schofield, J.D.; Liu, Y.; Rao-Balakrishna, P.; Malik, R.A.; Soran, H. Diabetes Dyslipidemia. Diabetes Ther., 2016, 7(2), 203-219.
[http://dx.doi.org/10.1007/s13300-016-0167-x] [PMID: 27056202]
[2]
Mooradian, A.D. Dyslipidemia in type 2 diabetes mellitus. Nat. Clin. Pract. Endocrinol. Metab., 2009, 5(3), 150-159.
[PMID: 19229235]
[3]
Jacobs, M.J.; Kleisli, T.; Pio, J.R.; Malik, S.; L’Italien, G.J.; Chen, R.S.; Wong, N.D. Prevalence and control of dyslipidemia among persons with diabetes in the United States. Diabetes Res. Clin. Pract., 2005, 70(3), 263-269.
[http://dx.doi.org/10.1016/j.diabres.2005.03.032] [PMID: 15890427]
[4]
Filippatos, T.D.; Florentin, M.; Georgoula, M.; Elisaf, M.S. Pharmacological management of diabetic dyslipidemia. Expert Rev. Clin. Pharmacol., 2017, 10(2), 187-200.
[http://dx.doi.org/10.1080/17512433.2017.1263565] [PMID: 27868450]
[5]
Chehade, J.M.; Gladysz, M.; Mooradian, A.D. Dyslipidemia in type 2 diabetes: prevalence, pathophysiology, and management. Drugs, 2013, 73(4), 327-339.
[http://dx.doi.org/10.1007/s40265-013-0023-5] [PMID: 23479408]
[6]
Vijayaraghavan, K. Treatment of dyslipidemia in patients with type 2 diabetes. Lipids Health Dis., 2010, 9, 144.
[http://dx.doi.org/10.1186/1476-511X-9-144] [PMID: 21172030]
[7]
Al-Snafi, A.E. Therapeutic properties of medicinal plants: a review of plants with hypolipidemic, hemostatic, fibrinolytic and anticoagulant effects (part 1). Asian J. Pharm. Sci. Technol., 2015, 5, 271-284.
[8]
Hasani-Ranjbar, S.; Nayebi, N.; Moradi, L.; Mehri, A.; Larijani, B.; Abdollahi, M. The efficacy and safety of herbal medicines used in the treatment of hyperlipidemia; a systematic review. Curr. Pharm. Des., 2010, 16(26), 2935-2947.
[http://dx.doi.org/10.2174/138161210793176464] [PMID: 20858178]
[9]
Ghorbani, A. Phytotherapy for diabetic dyslipidemia: evidence from clinical trials, 2013. 8, pp. 336-345.
[http://dx.doi.org/10.2217/clp.13.26]
[10]
Ghorbani, A. Clinical and experimental studies on polyherbal formulations for diabetes: current status and future prospective. J. Integr. Med., 2014, 12(4), 336-345.
[http://dx.doi.org/10.1016/S2095-4964(14)60031-5] [PMID: 25074883]
[11]
Ghorbani, A.; Shafiee-Nick, R.; Rakhshandeh, H.; Borji, A. Antihyperlipidemic effect of a polyherbal mixture in streptozotocin-induced diabetic rats. J. Lipids, 2013.2013675759
[http://dx.doi.org/10.1155/2013/675759] [PMID: 24383002]
[12]
Shafiee-Nick, R.; Ghorbani, A.; Vafaee Bagheri, F.; Rakhshandeh, H. Chronic administration of a combination of six herbs inhibits the progression of hyperglycemia and decreases serum lipids and aspartate amino transferase activity in diabetic rats. Adv. Pharmacol. Sci., 2012.2012789796
[http://dx.doi.org/10.1155/2012/789796] [PMID: 23304131]
[13]
Zarvandi, M.; Rakhshandeh, H.; Abazari, M.; Shafiee-Nick, R.; Ghorbani, A. Safety and efficacy of a polyherbal formulation for the management of dyslipidemia and hyperglycemia in patients with advanced-stage of type-2 diabetes. Biomed. Pharmacother., 2017, 89, 69-75.
[http://dx.doi.org/10.1016/j.biopha.2017.02.016] [PMID: 28214690]
[14]
Bunyapraphatsara, N.; Yongchaiyudha, S.; Rungpitarangsi, V.; Chokechaijaroenporn, O. Antidiabetic activity of Aloe vera L. juice II. Clinical trial in diabetes mellitus patients in combination with glibenclamide. Phytomedicine, 1996, 3(3), 245-248.
[http://dx.doi.org/10.1016/S0944-7113(96)80061-4] [PMID: 23195078]
[15]
Yongchaiyudha, S.; Rungpitarangsi, V.; Bunyapraphatsara, N.; Chokechaijaroenporn, O. Antidiabetic activity of Aloe vera L. juice. I. Clinical trial in new cases of diabetes mellitus. Phytomedicine, 1996, 3(3), 241-243.
[http://dx.doi.org/10.1016/S0944-7113(96)80060-2] [PMID: 23195077]
[16]
Kaatabi, H.; Bamosa, A.O.; Lebda, F.M.; Al Elq, A.H.; Al-Sultan, A.I. Favorable impact of Nigella sativa seeds on lipid profile in type 2 diabetic patients. J. Family Community Med., 2012, 19(3), 155-161.
[http://dx.doi.org/10.4103/2230-8229.102311] [PMID: 23230380]
[17]
Najmi, A.; Haque, S.; Naseeruddin, M.; Khan, R. Effect of Nigella sativa oil on various clinical and biochemical parameters of metabolic syndrome. Int. J. Diabetes Dev. Ctries., 2008, 16, 85-87.
[18]
Mirunalini, S.; Krishnaveni, M.; Ambily, V. Effects of raw garlic (Allium sativum) on hyperglycemia in patients with type 2 diabetes mellitus. Pharmacologyonline, 2011, 2, 968-974.
[19]
Ashraf, R.; Aamir, K.; Shaikh, A.R.; Ahmed, T. Effects of garlic on dyslipidemia in patients with type 2 diabetes mellitus. J. Ayub Med. Coll. Abbottabad, 2005, 17(3), 60-64.
[PMID: 16320801]
[20]
Varma, M.; Sharma, D.K.; Paaneri, S.; Mishra, A.; Sinha, A.; Varma, V. Potential clinical benefits of garlic (Allium sativum). J. Environ. Res. Dev., 2011, 5, 652-655.
[21]
Ashraf, R.; Khan, R.A.; Ashraf, I. Garlic (Allium sativum) supplementation with standard antidiabetic agent provides better diabetic control in type 2 diabetes patients. Pak. J. Pharm. Sci., 2011, 24(4), 565-570.
[PMID: 21959822]
[22]
Bordia, A.; Verma, S.K.; Srivastava, K.C. Effect of ginger (Zingiber officinale Rosc.) and fenugreek (Trigonella foenumgraecum L.) on blood lipids, blood sugar and platelet aggregation in patients with coronary artery disease. Prostaglandins Leukot. Essent. Fatty Acids, 1997, 56(5), 379-384.
[http://dx.doi.org/10.1016/S0952-3278(97)90587-1] [PMID: 9175175]
[23]
Moosa, A.S.M.; Rashid, M.U.; Asadi, A.; Ara, N.; Uddin, M.M.; Ferdaus, A. Hypolipidemic effects of fenugreek seed powder. Bangladesh J. Pharmacol., 2006, 1, 64-67.
[24]
Kassaian, N.; Azadbakht, L.; Forghani, B.; Amini, M. Effect of fenugreek seeds on blood glucose and lipid profiles in type 2 diabetic patients. Int. J. Vitam. Nutr. Res., 2009, 79(1), 34-39.
[http://dx.doi.org/10.1024/0300-9831.79.1.34] [PMID: 19839001]
[25]
Gupta, A.; Gupta, R.; Lal, B. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. J. Assoc. Physicians India, 2001, 49, 1057-1061.
[PMID: 11868855]
[26]
Sharma, R.D.; Raghuram, T.C.; Rao, N.S. Effect of fenugreek seeds on blood glucose and serum lipids in type I diabetes. Eur. J. Clin. Nutr., 1990, 44(4), 301-306.
[PMID: 2194788]
[27]
Anderson, J.W.; Allgood, L.D.; Turner, J.; Oeltgen, P.R.; Daggy, B.P. Effects of psyllium on glucose and serum lipid responses in men with type 2 diabetes and hypercholesterolemia. Am. J. Clin. Nutr., 1999, 70(4), 466-473.
[http://dx.doi.org/10.1093/ajcn/70.4.466] [PMID: 10500014]
[28]
Sierra, M.; García, J.J.; Fernández, N.; Diez, M.J.; Calle, Á.P.; Álvarez, J.C.; Carriedo, D.; Castro, L.J.; Torre, M.; González, A. Therapeutic effects of psyllium in type 2 diabetic patients. Eur. J. Clin. Nutr., 2002, 56(9), 830-842.
[http://dx.doi.org/10.1038/sj.ejcn.1601398] [PMID: 12209371]
[29]
Cicero, A.F.; Derosa, G.; Bove, M.; Imola, F.; Borghi, C.; Gaddi, A.V. Psyllium improves dyslipidaemia, hyperglycaemia and hypertension, while guar gum reduces body weight more rapidly in patients affected by metabolic syndrome following an AHA Step 2 diet. Med. J. Nutrition Metab., 2010, 3, 47-54.
[http://dx.doi.org/10.1007/s12349-009-0056-1]
[30]
Huseini, H.F.; Larijani, B.; Heshmat, R.; Fakhrzadeh, H.; Radjabipour, B.; Toliat, T.; Raza, M. The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled, clinical trial. Phytother. Res., 2006, 20(12), 1036-1039.
[http://dx.doi.org/10.1002/ptr.1988] [PMID: 17072885]
[31]
Ramezani, M.; Azarabadi, M.; Abdi, H.; Baher, G.; Huseini, M. The effects of Silybum marianum (L.) Gaertn. seed extract on glycemic control in type II diabetic patient’s candidate for insulin therapy visiting endocrinology clinic in baqiyatallah hospital in the years of 2006. Faslnamah-i Giyahan-i Daruyi, 2008, 2, 79-84.
[32]
Madhav, N.S.; Upadhyaya, K.; Bisht, A. Phytochemical screening and standardization of polyherbal formulation for dyslipidemia. Int. J. Pharm. Pharm. Sci., 2011, 3, 235-238.
[33]
Hosseini, A.; Mollazadeh, H.; Amiri, M.S.; Sadeghnia, H.R.; Ghorbani, A. Effects of a standardized extract of Rheum turkestanicum Janischew root on diabetic changes in the kidney, liver and heart of streptozotocin-induced diabetic rats. Biomed. Pharmacother., 2017, 86, 605-611.
[http://dx.doi.org/10.1016/j.biopha.2016.12.059] [PMID: 28027536]
[34]
Choudhary, M.; Kochhar, A.; Sangha, J. Hypoglycemic and hypolipidemic effect of Aloe vera L. in non-insulin dependent diabetics. J. Food Sci. Technol., 2014, 51(1), 90-96.
[http://dx.doi.org/10.1007/s13197-011-0459-0] [PMID: 24426052]
[35]
Sobenin, I.A.; Nedosugova, L.V.; Filatova, L.V.; Balabolkin, M.I.; Gorchakova, T.V.; Orekhov, A.N. Metabolic effects of time-released garlic powder tablets in type 2 diabetes mellitus: the results of double-blinded placebo-controlled study. Acta Diabetol., 2008, 45(1), 1-6.
[http://dx.doi.org/10.1007/s00592-007-0011-x] [PMID: 17823766]
[36]
Sharma, R. Effect of fenugreek seeds and leaves on blood glucose and serum insulin responses in human subjects. Nutr. Res., 1986, 6, 1353-1364.
[http://dx.doi.org/10.1016/S0271-5317(86)80020-3]
[37]
Sharma, R.; Raghuram, T. Hypoglycaemic effect of fenugreek seeds in non-insulin dependent diabetic subjects. Nutr. Res., 1990, 10, 731-739.
[http://dx.doi.org/10.1016/S0271-5317(05)80822-X]
[38]
Csermely, P.; Agoston, V.; Pongor, S. The efficiency of multi-target drugs: the network approach might help drug design. Trends Pharmacol. Sci., 2005, 26(4), 178-182.
[http://dx.doi.org/10.1016/j.tips.2005.02.007] [PMID: 15808341]
[39]
Lu, J-J.; Pan, W.; Hu, Y-J.; Wang, Y-T. Multi-target drugs: the trend of drug research and development. PLoS One, 2012, 7(6)e40262
[http://dx.doi.org/10.1371/journal.pone.0040262] [PMID: 22768266]
[40]
Nathan, D.M.; Genuth, S.; Lachin, J.; Cleary, P.; Crofford, O.; Davis, M.; Rand, L.; Siebert, C. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N. Engl. J. Med., 1993, 329(14), 977-986.
[http://dx.doi.org/10.1056/NEJM199309303291401] [PMID: 8366922]
[41]
Group, U.P.D.S. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet, 1998, 352(9131), 837-853.
[http://dx.doi.org/10.1016/S0140-6736(98)07019-6] [PMID: 9742976]
[42]
Ohkubo, Y.; Kishikawa, H.; Araki, E.; Miyata, T.; Isami, S.; Motoyoshi, S.; Kojima, Y.; Furuyoshi, N.; Shichiri, M. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res. Clin. Pract., 1995, 28(2), 103-117.
[http://dx.doi.org/10.1016/0168-8227(95)01064-K] [PMID: 7587918]
[43]
Hannan, J.M.; Ali, L.; Rokeya, B.; Khaleque, J.; Akhter, M.; Flatt, P.R.; Abdel-Wahab, Y.H. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate digestion and absorption, and enhancing insulin action. Br. J. Nutr., 2007, 97(3), 514-521.
[http://dx.doi.org/10.1017/S0007114507657869] [PMID: 17313713]
[44]
Hannan, J.M.; Ali, L.; Khaleque, J.; Akhter, M.; Flatt, P.R.; Abdel-Wahab, Y.H. Aqueous extracts of husks of Plantago ovata reduce hyperglycaemia in type 1 and type 2 diabetes by inhibition of intestinal glucose absorption. Br. J. Nutr., 2006, 96(1), 131-137.
[http://dx.doi.org/10.1079/BJN20061819] [PMID: 16870001]
[45]
Ghorbani, A. Best herbs for managing diabetes: A review of clinical studies. Braz. J. Pharm. Sci., 2013, 49, 413-422.
[http://dx.doi.org/10.1590/S1984-82502013000300003]
[46]
Hosseini, A.; Shafiee-Nick, R.; Ghorbani, A. Pancreatic beta cell protection/regeneration with phytotherapy. Braz. J. Pharm. Sci., 2015, 51, 1-16.
[http://dx.doi.org/10.1590/S1984-82502015000100001]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy