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)
Mechanism and Biochemical Profile
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>).