Berberine chloride hydrate Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate the biological and pharmacological profile of berberine chloride hydrate, focusing on pharmacokinetics in healthy volunteers and therapeutic efficacy in polycystic ovary syndrome (PCOS). Sponsored by academic and medical centers such as University Medicine Greifswald and Ayub Teaching Hospital, these Phase Not Applicable protocols range in recruitment status from completed to currently recruiting and not yet recruiting. Across these studies, key parameters under investigation include genetic polymorphisms, dietary impact, sex differences, and endocrine outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06273241	Not yet recruiting	Pharmacokinetic Study in Healthy Volunteers	University Medicine Greifswald	2024-03-04	Not Applicable
NCT05845931	Recruiting	Pharmacokinetic Study in Healthy Volunteers	University Medicine Greifswald	2023-05-05	Not Applicable
NCT05480670	Completed	Polycystic Ovary Syndrome	Ayub Teaching Hospital	2022-11-01	Not Applicable
NCT05463003	Completed	Pharmacokinetic Study in Healthy Volunteers	University Medicine Greifswald	2022-07-19	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Berberine chloride hydrate acts as a dual topoisomerase I and II inhibitor that suppresses anti-apoptotic proteins Bcl-2 and Bcl-XL, generates reactive oxygen species, and activates caspase-3 and caspase-8 pathways. This molecular inhibition drives apoptotic cell death and autophagic modulation, establishing the mechanistic rationale for clinical studies assessing its metabolic effects in polycystic ovary syndrome and characterization in human pharmacokinetic trials.

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>).