Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic and diagnostic utility of dextrose across diverse medical indications. These investigations encompass conditions such as type 1 and type 2 diabetes, acute brain injury, volume overload in heart failure, lateral epicondylitis, and carpal tunnel syndrome, evaluating interventions ranging from metabolic management to dextrose prolotherapy and nerve hydrodissection. Sponsored by academic medical centers and health institutions—including Yale University, Turku University Hospital, and Cairo University—these studies reflect varied recruitment statuses ranging from active and recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07798258 ACTIVE_NOT_RECRUITING
TMD
Cairo University
2025-10-10 PHASE2
NCT07552298 RECRUITING
Coccydynia
Istanbul University
2025-06-15
NCT07008456 RECRUITING
Obese With Comorbidities; Obese Patients (BMI ≥ 30 kg/m²)
Aphaia Pharma US LLC
2025-09-12 PHASE2
NCT06522204 COMPLETED
Preoperative Fasting
Karaman Training and Research Hospital
2024-07-30
NCT07620678 COMPLETED
Lateral Epicondylitis (Tennis Elbow); Lateral Epicondylitis
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
2023-10-01
NCT04918719 COMPLETED
Acute Ischemic Stroke
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
2023-11-02 PHASE2
NCT06343974 Not yet recruiting
Pregnancy in Diabetic|Diabetes Mellitus Type 1
Turku University Hospital
2024-06-01 --
NCT06393049 Not yet recruiting
Acute Brain Injury
Rigshospitalet Denmark
2024-05-08 Not Applicable
NCT06148649 Recruiting
Type 2 Diabetes
Dongguan HEC Biopharmaceutical R&D Co. Ltd.
2023-12-10 Phase 2
NCT06140108 Completed
Polycystic Ovary Syndrome|Weight Gain|HbA1c
SINA Health Education and Welfare Trust
2023-12-15 Phase 2|Phase 3
NCT06909305 COMPLETED
Intraarticular; Ozone; Prolotherapy; Dexmedetomidine; Pain; Knee Osteoarthritis
Tanta University
2022-10-01
NCT07015450 COMPLETED
Neonatal Hypoglycemia
Indonesia University
2023-05-01 PHASE4
NCT05725460 COMPLETED
Carpal Tunnel Syndrome
Iraqi Board of medical specialties
2023-02-01
NCT03306316 COMPLETED
Preterm Infant; Development, Infant; Nutrition
Nationwide Children's Hospital
2018-07-04
NCT06189651 COMPLETED
Carpal Tunnel Syndrome
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
2021-11-01
NCT03829683 COMPLETED
Alcoholic Hepatitis; Sepsis
Virginia Commonwealth University
2019-04-16 PHASE2
NCT04796103 COMPLETED
Chondromalacia Patellae
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
2020-09-19
NCT04802785 UNKNOWN
Air Travel
Dinara Zhumanbayeva
2021-06 PHASE2; PHASE3
NCT04294966 COMPLETED
Tolerance; Adolescent Behavior; THC
University of Chicago
2020-03-10 EARLY_PHASE1
NCT03447158 COMPLETED
Subacromial Bursitis
Mackay Memorial Hospital
2018-07-18
NCT03801226 COMPLETED
Potential Applications for Heart Failure; Volume Overload
Yale University
2018-12-01 EARLY_PHASE1
NCT02989675 TERMINATED
Hypoglycemia Non Diabetics; Emergencies; Pediatric ALL; Critical Illness
Helena Hildenwall
2016-12
NCT02710266 TERMINATED
Liver Disease
Yonsei University
2012-02-24 PHASE3
NCT02590081 UNKNOWN
End-Stage Kidney Disease; Hemodialysis
Penang Hospital, Malaysia
2015-10 PHASE4
NCT02492945 COMPLETED
Lateral Epicondylitis
Seoul National University Bundang Hospital
2015-06 PHASE4
NCT02655783 COMPLETED
Delivery Uterine
Université de Sherbrooke
2013-01
NCT02376218 COMPLETED
Pulmonary Surgical Procedures
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
2015-04
NCT01210183 COMPLETED
Knee Osteoarthritis
Universidad Nacional de Rosario
2010-07 PHASE2; PHASE3
NCT01167569 COMPLETED
Reperfusion Injury
Rutgers, The State University of New Jersey
2007-10 PHASE4
NCT01075984 COMPLETED
Fungal Infection
Merck Sharp & Dohme LLC
2010-02-23 PHASE1
NCT01296620 COMPLETED
Gastrointestinal Dysmotility
Tranzyme, Inc.
2011-02 PHASE3
NCT02185729 COMPLETED
Diseases, Metabolic; Insulin Sensitivity
Emory University
2008-06 PHASE2; PHASE3
NCT01285713 COMPLETED
Dehydration
Children's Hospital of Philadelphia
2010-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-01)

Check the Dextrose product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dextrose, an essential D-monosaccharide, undergoes cellular uptake via specialized glucose transporters and enters glycolysis and oxidative phosphorylation to generate adenosine triphosphate and maintain cellular metabolic homeostasis. This fundamental role in bioenergetics and osmolar modulation provides the clinical basis for its therapeutic utilization in correcting hypoglycemia and glycemic dysfunction in diabetes, as well as serving as an injectable tissue-modulating agent in musculoskeletal clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.