Chlorophyllin (sodium copper salt) Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A clinical trial evaluated chlorophyllin (sodium copper salt) supplementation for supporting balanced bowel function and managing gastrointestinal symptoms in healthy volunteers. Sponsored by the industry entity Nature's Sunshine Products Inc., this completed investigation carried a phase designation of Not Applicable. The findings provide key insights into the safety profile and physiological tolerance of chlorophyllin for human digestive wellness.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03685552	Completed	Gastrointestinal Symptoms	Nature''s Sunshine Products Inc.	2017-08-03	Not Applicable

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

Check the Chlorophyllin (sodium copper salt) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chlorophyllin acts as a potent antioxidant and antimutagenic agent that scavenges reactive oxygen species and forms tight molecular complexes with planar environmental mutagens, thereby preventing cellular oxidative damage and carcinogen-induced DNA adduct formation. This attenuation of cellular toxicity and oxidative stress within intestinal epithelial tissues mitigates mucosal irritation, providing a physiological basis for supporting bowel function and managing gastrointestinal symptoms.

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>).