Curcumol Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

A clinical trial evaluated the compound for managing chemotherapy-induced oral mucositis in pediatric patients receiving doxorubicin-based regimens. Sponsored by a medical organization, the Hadassah Medical Organization, this randomized phase III study has completed recruitment. Overall, these trial data reflect clinical interest in evaluating the protective efficacy of the agent against treatment-related oral toxicities in pediatric cancer patients.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00475683	COMPLETED	Chemotherapy Induced Mucositis	Hadassah Medical Organization	2009-01	PHASE3

(data from https://clinicaltrials.gov, updated on 2015-08-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Curcumol promotes the rapid translocation of pro-apoptotic Bax from the cytosol into mitochondria, which dissipates mitochondrial membrane potential and triggers caspase-independent cell death in target cells. This mitochondrial-mediated apoptotic response and pathway modulation provide the biological rationale for evaluating its therapeutic potential in mitigating chemotherapy-induced mucositis.

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>).