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      The hypoglycemic effects of Juglans regia L. internal septum in type 2 diabetic patients: A double-blind, randomized, placebo-controlled clinical trial

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          Abstract

          Introduction:

          The internal septum of J.regia is traditionally used to control diabetes, and its effectiveness has been shown in animal studies. Accordingly, human clinical trials are needed to confirm its effectiveness on hemoglobin A1c (HbA1c), fasting blood sugar (FBS), blood insulin level, and insulin resistance as a complementary for better control of type 2 diabetes.

          Methods:

          This study was a randomized, double-blinded, controlled trial. The lyophilized powder of extract of the internal septum of J.regia was used to fill the capsules. Sixty type 2 diabetic patients were randomly divided into two groups. 500 mg capsules three times daily before meal was added to their routine drug regimen, and HbA1c, FBS, and blood insulin level were checked at the baseline and after three months.

          Results:

          Sixty patients completed the study. The mean(±SD) age of patients was 49.1(10.2) and 50.9(12.7) years in the placebo and J.regia groups, respectively. We observed that J.regia internal septum increases the level of HbA1c by about 0.02 units, but this effect was not significant (MD=0.02,95%CI=-0.36 to 0.40, P=0.93). Regarding the impact of capsules on insulin level, it seems that J.regia-containing capsules can raise insulin level by one unit. However, it was not significant (MD=1.01,95%CI=-0.86 to 2.88, P=0.28). As for FBS, it can cause a decrease of four units, but this effect is also not significant (MD=-3.98,95%CI=-18.33 to 10.37, P=0.58).

          Conclusion:

          Based on our study, the internal septum of J.regia has no significant effect on HbA1c, FBS, and insulin resistance. Moreover, no specific adverse reaction was observed in any of the patients.

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          Most cited references34

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          2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk

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            A simple practice guide for dose conversion between animals and human

            Understanding the concept of extrapolation of dose between species is important for pharmaceutical researchers when initiating new animal or human experiments. Interspecies allometric scaling for dose conversion from animal to human studies is one of the most controversial areas in clinical pharmacology. Allometric approach considers the differences in body surface area, which is associated with animal weight while extrapolating the doses of therapeutic agents among the species. This review provides basic information about translation of doses between species and estimation of starting dose for clinical trials using allometric scaling. The method of calculation of injection volume for parenteral formulation based on human equivalent dose is also briefed.
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              A method for estimating the probability of adverse drug reactions.

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                Author and article information

                Contributors
                Role: InvestigationRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Resources
                Role: ResourcesRole: Writing – review & editing
                Role: Resources
                Role: Conceptualization
                Role: Methodology
                Role: InvestigationRole: Validation
                Role: ConceptualizationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Journal
                J Cardiovasc Thorac Res
                J Cardiovasc Thorac Res
                J Cardiovasc Thorac Res
                TBZMED
                Journal of Cardiovascular and Thoracic Research
                Tabriz University of Medical Sciences
                2008-5117
                2008-6830
                2023
                23 September 2023
                : 15
                : 3
                : 145-153
                Affiliations
                1Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences (TUMS), Tehran, Iran
                2Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran
                3Endocrinology and Metabolism Research Center (EMRC), Tehran University of Medical Sciences, Vali-Asr Hospital, Imam Khomeini Complex Hospital, Tehran, Iran
                4Endocrinology and Metabolism Clinical Sciences Institute, Endocrinology and Metabolism Research Center, Tehran University of Medical Sciences, Tehran, Iran
                5Elderly Health Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
                6Pharmacognosy Department, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
                7Research Center for Rational Use of Drugs, Tehran University of Medical Sciences (TUMS), Tehran, Iran
                Author notes
                [* ] Corresponding Author: Soha Namazi, Email: namazisoha@ 123456yahoo.com
                Author information
                https://orcid.org/0000-0003-2938-2025
                https://orcid.org/0000-0003-4351-3861
                https://orcid.org/0000-0002-6150-1648
                Article
                10.34172/jcvtr.2023.31835
                10590466
                38028721
                8799d6fb-0cc3-4760-8fa5-9fa13db6a98d
                © 2023 The Author(s)

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 06 April 2023
                : 19 August 2023
                Categories
                Original Article

                diabetes mellitus,juglans regia,herbal medicine,insulin resistance,trial

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