Castor oil Clinical Trials

Clinical Trials

Several clinical trials evaluate castor oil across obstetric and ophthalmologic indications, specifically investigating cervical ripening and labor induction—in nulliparous, multiparous, and prior cesarean patients—as well as dry eye syndrome and ametropia. Conducted by academic and healthcare entities such as Cairo University, Holy Family Hospital Nazareth, and the Federal University of São Paulo, recruitment statuses range from recruiting to completed. All registered protocols carry a phase designation of Not Applicable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06325007	Recruiting	Induction of Labor Affected Fetus / Newborn	Holy Family Hospital Nazareth Israel	2024-04-11	Not Applicable
NCT06335017	Recruiting	Induction of Labor	Holy Family Hospital Nazareth Israel	2024-04-10	Not Applicable
NCT03958981	Completed	Induction of Labor	Cairo University\|Mohamed El Sharkawy\|Yomna Bayoumi\|mohamed hisham gouda\|Dina latif	2019-07-15	Not Applicable
NCT01741987	Completed	Dry Eye\|Ametropia	Federal University of São Paulo	2008-10	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Following metabolic breakdown, castor oil yields ricinoleic acid, which selectively activates prostanoid EP3 receptors to trigger intracellular calcium mobilization and smooth muscle contraction. This receptor-mediated stimulation of uterine contractility, alongside its lipid-replenishing properties on ocular surface epithelia, directly underpins its clinical evaluation for the induction of labor and the management of dry eye syndrome.

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>).