A Phase 3 interventional study of NW Low-Glu® and Metformin in Diabetes Mellitus, Type 2, sponsored by Natural Wellness Egypt. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Natural Wellness Egypt · Phase 3, Interventional, and Treatment
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:
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.
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.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 400 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Natural Wellness Egypt is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Patients must meet all of the following criteria to be eligible for enrolment into the study.
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible for enrolment into the study.
Patients in this arm will receive one placebo tablet plus two NW Low-Glu® capsules administered PO on empty stomach with plenty of water 2 hours after meals twice daily. A total dose of four NW Low-Glu® capsules will be administered per day.
Dietary Supplement: NW Low-Glu®
Patients in this arm will receive one metformin 1000 mg tablet plus two placebo capsules administered PO on an empty stomach with plenty of water 2 hours after meals twice daily. A total dose of Metformin 2000 mg will be administered per day.
Drug: Metformin
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).
Patients in the active comparator arm will receive a total of 2000 mg of metformin per day.
Comparing the mean change in HbA1c levels between the experimental arm and the active-control arm
To compare the hypoglycemic effect of a herbal medicinal product (NW Low-Glu) to that of metformin as measured by the mean change in HbA1c levels in patients with type II diabetes mellitus.
Time frame: 6 months
Comparing the mean change in HbA1c levels between the experimental arm and the active-control arm Comparing the mean change in fasting blood glucose levels
To compare the hypoglycemic effect of a herbal medicinal product (NW Low-Glu) to that of metformin as measured by the mean change in fasting blood glucose levels in patients with type II diabetes mellitus.
Time frame: 6 months
Measuring the incidence of AEs, SAEs, TEAEs, hypoglycemic events, and abnormal laboratory test findings in both the experimental arm and the active comparator arm
To measure the incidence of adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), hypoglycemic events, and abnormal laboratory test findings in both the experimental arm and active comparator arm
Time frame: 6 months
Assessing cardiovascular AEs in both the experimental arm and the active comparator arm
To measure the number, nature, and severity of cardiovascular AEs and their causal relationship to the received intervention in both the experimental arm and active comparator arm
Time frame: 6 months
Comparing the mean change in weight between the experimental arm and the active-control arm
To compare the mean change in body weight between the experimental arm and the active comparator arm
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Sep 2025, 18 months later.
Of 430 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's planned 18 months is close to that.
Counting every sponsor, half of 510 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Natural Wellness Egypt