Gallic acid Clinical Trials

Size	Price	Qty
100mg	USD 147
500mg	USD 297

Clinical Trials

Several clinical trials evaluate gallic acid or related dietary polyphenolic compounds across conditions including metabolic endotoxemia and inflammation in obesity, anti-doping steroid profile monitoring, and multiple system atrophy. Spanning Phase 1, Phase 3, and non-applicable phase classifications, these studies are sponsored by academic institutions, anti-doping authorities, and specialized research centers. Recruitment statuses among these trials range from completed to unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03413735	Unknown status	Obesity\|Endotoxemia\|Inflammation	Ohio State University	2018-08-29	Not Applicable
NCT02779361	Completed	Healthy Volunteers\|Doping in Sports	Parc de Salut Mar\|World Anti-Doping Agency	2016-01	Phase 1
NCT02008721	Completed	Multiple System Atrophy	Dr. Johannes Levin\|German Center for Neurodegenerative Diseases (DZNE)\|Deutsche Parkinson Vereinigung\|German Foundation for Neurology\|ParkinsonFonds Deutschland gGmbH\|Ludwig-Maximilians - University of Munich	2014-01	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gallic acid functions as a potent antioxidant and free radical scavenger that suppresses reactive oxygen species generation and inhibits pro-inflammatory signaling pathways, thereby dampening cellular oxidative stress and downregulating inflammatory cytokine production. This attenuation of oxidative damage and systemic inflammatory cascades provides the biological rationale for evaluating gallic acid formulations in clinical trials targeting metabolic endotoxemia, systemic inflammation, and neurodegenerative disorders such as multiple system atrophy.

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>).