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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
Phase 3 trial testing NW Low-Glu® in Diabetes Mellitus, Type 2 in 400 participants. Status unknown.
1 September 2025
Quick facts
| Lead sponsor | Natural Wellness Egypt |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 1 March 2024 |
| Primary completion | 1 September 2025 |
| Estimated completion | 1 October 2025 |
Drugs / interventions tested
- NW Low-Glu®
- Metformin (metformin) — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
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.
-
Comparing the mean change in HbA1c levels between the experimental arm and the active-control arm
Time frame: 6 months
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.
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):
-
<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
Verify or expand the search:
- PubMed search for NCT06140485
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
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- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Natural Wellness Egypt trials
Trials by the same sponsor.
- NCT05347329 — A Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus · NA · completed
- NCT05343780 — Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of NASH · Phase 2 · completed
- NCT05343767 — Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06140485 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Natural Wellness Egypt
- Last refreshed: 20 November 2023
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