Several clinical trials evaluate conditions relevant to Cycloastragenol research, including Alzheimer's disease, acute ST-elevation myocardial infarction, Chopra-Amiel-Gordon syndrome, and periodontal diseases. Encompassing Phase 2 and non-applicable phase classifications, these actively recruiting and completed studies investigate cognitive function, retinal amyloid markers, rapid myocardial infarction identification, and periodontal tissue preservation. These initiatives are primarily sponsored by academic and medical institutions.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05777083 | Recruiting | ST Elevation Myocardial Infarction|Electrocardiogram |
Ewha Womans University Mokdong Hospital |
2023-01-01 | Not Applicable |
| NCT05578443 | Recruiting | Alzheimer''s Disease |
Fujian Medical University Union Hospital |
2022-10-01 | Phase 2 |
| NCT05528744 | Recruiting | Genetic Disease|Chopra-Amiel-Gordon Syndrome|CAGS|ANKRD17 |
Boston Children''s Hospital |
2022-08-27 | -- |
| NCT05533528 | Recruiting | Periodontal Pocket|Periodontal Diseases|Periodontal Bone Loss |
Universidad de Murcia |
2022-05-03 | Not Applicable |
| NCT05118009 | Completed | Myocardial Infarction Acute |
National Defense Medical Center Taiwan |
2022-05-01 | Not Applicable |
| NCT02530255 | COMPLETED | Alzheimer Disease |
Chippewa Valley Eye Clinic |
2016-12-01 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).