NCT06140485

A Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients With Type II Diabetes Mellitus

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Natural Wellness Egypt · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate efficacy and safety of an herbal medicinal product of (NW Low-Glu®) in patients with Type 2 Diabetes Mellitus (T2DM). The main question\[s\] it aims to answer are: • What will be the mean change in HbA1c levels in the experimental arm (NW Low-Glu®) compared to the active-control arm (metformin) after 6 months of treatment? Participants will randomized in a 1:1 allocation ratio, into one of the two treatment groups, to receive either Metformin or NW Low-Glu®. Researchers will compare the mean change in HbA1C, fasting blood glucose, and weight between the experimental arm and the active-control arm.

Detailed description

Despite the advancements in drug discovery and the increase in the total budget spent on pharmaceutical research and development, the number of new drug approvals has decreased in the recent years. Not only do plants serve as foods, but they have also been an integral part of therapeutic interventions in traditional and alternative medicine throughout human history. Because plants comprise a large number of monomeric compounds, herbal medicine continues to play a multi-targeted approach role in treating diseases. It is estimated that 25% of modern drugs are derived from natural products. In addition, the World Health Organization (WHO) estimates that between 65% and 80% of developing countries use medicinal plants as remedies. In a study conducted in Alexandria, Egypt, the rate of using complementary and alternative medicine (CAM) at least once among type 2 diabetes mellitus (T2DM) patients was 41.7%, with 26.3% being regular CAM users. The main reason for resorting to CAM was the belief in its benefits. The powdered extracts of Ficus deltoidea leaves, Cinnamomum cassia bark, and Nigella Sativa seeds (Black Seeds) have been used for the treatment of diabetes and other medical conditions for over 2000 years. Studies on the individual effect of each of these medicinal plants have demonstrated antihyperglycemic efficacy in individuals with T2DM. For example, Kalman et al. reported significant reduction in glucose and lipid levels upon testing the antidiabetic effects of F. deltoidea in adults with prediabetes. There is also strong evidence to support the efficacy of Cinnamomum cassia in lowering fasting plasma glucose (FPG). In a randomized controlled trial, poorly controlled T2DM patients receiving an aqueous extract equivalent to 3 grams of Cinnamomum cassia for 4 months had significantly higher reduction in FPG compared to placebo (10.3% vs 3.4%). Furthermore, Nigella Sativa seeds' extract (in combination with oral hypoglycemic drugs) led to significant reductions in FPG, 2-hour post-prandial glucose (2 hr PPG), HbA1c, and insulin resistance at 12 weeks, which makes it a possible beneficial adjuvant therapy to oral hypoglycemics in patients with uncontrolled T2DM. A combination of the mentioned medicinal herbs is registered as NW Low-Glu® (a dietary supplement; one capsule constitutes 300 mg Mas Cotek powdered extract \[from leaves of Ficus deltoidea Jack by aqueous solvent extraction\] + 100 mg Cinnamomum cassia L. powdered extract +250 mg Black Seed powdered extract \[from seeds of Nigella sativa L. by 70% hydro-alcoholic extraction\]) in the Malaysian market under the registration number MAL15070037 T. The efficacy and safety NW Low-Glu® was investigated in a phase II study in 2022, in which the hypoglycemic effect of two doses of the herbal medicinal product was compared in patients newly diagnosed with T2DM. Correspondingly, the results of the phase II study warranted further assessment of NW Low-Glu® activity in patients inclined to benefit from it.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NW Low-Glu®	One NW Low-Glu® capsule contains Mas Cotek powdered Extract 300 mg (from leaves of Ficus deltoidea Jack by aqueous solvent extraction) + Cinnamomum cassia L. powdered Extract 100 mg + Black seed powdered extract 250 mg (from seeds of Nigella sativa L. by 70% hydro-alcoholic extraction).
DRUG	Metformin	Patients in the active comparator arm will receive a total of 2000 mg of metformin per day.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2023-11-20
• Last updated: 2023-11-22