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NCT06140485

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 3 Last updated 20 November 2023
What this trial tests

Phase 3 trial testing NW Low-Glu® in Diabetes Mellitus, Type 2 in 400 participants. Status unknown.

Timeline
1 March 2024
Primary endpoint
1 September 2025
1 October 2025

Quick facts

Lead sponsorNatural Wellness Egypt
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment400
Start date1 March 2024
Primary completion1 September 2025
Estimated completion1 October 2025

Drugs / interventions tested

Conditions studied

Sponsor

Natural Wellness Egypt — full company profile →

Who can join

Adults 18 to 65, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. <i>Nigella sativa</i>: A Comprehensive Review of Its Therapeutic Potential, Pharmacological Properties, and Clinical Applications.
    Alberts A, Moldoveanu ET, Niculescu AG, Grumezescu AM. · · 2024 · cited 12× · PMID 39769174 · DOI 10.3390/ijms252413410

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Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other Natural Wellness Egypt trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06140485.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing