A Phase II, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients Newly Diagnosed with Type 2 Diabetes Mellitus.

Autor: Assaad-Khalil S; Department of Internal Medicine, Unit of Diabetology, Lipidology & Metabolism Faculty of Medicine, Alexandria University, Alexandria, Egypt., Elkafrawy N; Department of Internal Medicine, Unit of Endocrinology & Diabetes, Faculty of Medicine, Menoufia University, Shebin El Kom, Menoufia, Egypt., Khaled M; Egyptian National Institute of Diabetes and Endocrinology, Cairo, Egypt., Mogeib O; Department of Endocrinology, National Research Center, Giza, Egypt., Badr H; Department of Internal Medicine, Unit of Endocrinology & Diabetes, Faculty of Medicine, Menoufia University, Shebin El Kom, Menoufia, Egypt., Rashwan A; Unit of Critical Care Medicine, Fayoum General Hospital, Fayoum, Egypt., Youssef M; Department of Cardiovascular Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt., Eltamawy K; Unit of Cardiology, Assiut General Hospital, Assiut, Egypt., Mohamed S; School of Pharmaceutical Sciences, University Sains Malaysia, George, Malaysia.
Jazyk: angličtina
Zdroj: Evidence-based complementary and alternative medicine : eCAM [Evid Based Complement Alternat Med] 2022 Sep 27; Vol. 2022, pp. 9176026. Date of Electronic Publication: 2022 Sep 27 (Print Publication: 2022).
DOI: 10.1155/2022/9176026
Abstrakt: Background: Medicinal plants have long been used for the treatment of type 2 diabetes mellitus (T2DM). This study aimed to investigate the hypoglycemic efficacy and safety of NW Low-Glu® (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L . + 250 mg Nigella sativa L. powdered extracts) in treatment-naïve, newly diagnosed T2DM patients.
Methods: This was a 12-week, double-blind, double-dummy, randomized, phase 2 clinical trial. A total of 232 male and female patients aged ≥18 and ≤65 years who were newly diagnosed with T2DM and have not received any antidiabetic drugs before and were equally randomized to receive metformin (2000 mg per day), low-dose NW Low-Glu® (content of four capsules per day), or high-dose NW Low-Glu® (content of five capsules per day). Our primary objective was to measure the mean change in HbA1c between each of the experimental arms and the metformin arm.
Results: There was a significant reduction in mean HbA1c at 12 weeks compared to baseline in the low-dose (0.6 (1.4)%; p =0.002) and high-dose arms (0.8 (1.7)%; p =0.004). There was also a significant reduction in 2 hr PPG at 12 weeks in the low-dose (35.4 (74.9) mg/dL, p =0.001) and high-dose arms (24.7 (100.8) mg/dL, p =0.04). Weight reduction was significantly higher with both high-dose (1.1 (-1.7) Kg; p =0.005) and low-dose arms (0.9 (-1.5) Kg; p =0.023) compared to metformin (0.8 (-1.8) Kg). No serious AEs or deaths were reported.
Conclusions: After 3 months of treatment, NW Low-Glu® was noninferior to metformin in reducing HbA1c and 2 hr PPG, while leading to significantly higher weight reduction in newly diagnosed T2DM patients. It was also safe and well tolerated.
Competing Interests: Shahnaz Mohamed is an employee of Natural Wellness. The rest of the authors declare no conflicts of interest.
(Copyright © 2022 Samir Assaad-Khalil et al.)
Databáze: MEDLINE
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