Spirulina Powder Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 377

Clinical Trials

Multiple completed clinical trials have evaluated this material across diverse cohorts, including healthy volunteers, individuals with endometriosis, and lactating women contributing to regional milk banks. These studies encompass early-phase Phase 1 safety and dose-escalation evaluations alongside observational studies lacking formal phase designations. Sponsorship spans major pharmaceutical entities such as Pfizer as well as public healthcare and academic institutions, including Nantes University Hospital and Assistance Publique - Hôpitaux de Paris.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02070939	Completed	Healthy	Pfizer	2014-02	Phase 1
NCT02651077	Completed	Endometriosis	Nantes University Hospital\|ONIRIS	2013-11	--
NCT01848444	Completed	Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study	Assistance Publique - Hôpitaux de Paris	2013-10	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Spirulina powder contains bioactive components such as C-phycocyanin and superoxide dismutase that directly neutralize reactive oxygen species and inhibit downstream pro-inflammatory biochemical cascades. This cellular reduction in oxidative stress attenuates cell damage and restores metabolic function, supporting cardiovascular health and mitigating tissue inflammation in clinical settings such as endometriosis and metabolic evaluations.

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>).