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

NCT06140485 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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.

Sponsors & Collaborators

  • Natural Wellness Egypt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-09-30
Completion
2025-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06140485 on ClinicalTrials.gov