Clinical Trials

Multiple clinical trials across Early Phase 1 through Phase 4 and unassigned phase designs are evaluating sesame oil for catheter-induced phlebitis, gingivitis, dental plaque, oral microbial colonization, and perimenopausal sleep disturbances. Sponsored primarily by academic institutions and major healthcare centers, these studies range in recruitment status from completed and active, not recruiting to recruiting and not yet recruiting. Specific investigations evaluate topical administration to prevent catheter-associated vascular inflammation as well as oral pulling therapies for plaque reduction.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07665398 ACTIVE_NOT_RECRUITING
Bruxism; Bruxism, Sleep; Bruxism, Sleep-Related
Necmettin Erbakan University
 2024-09-02
NCT06592144 ACTIVE_NOT_RECRUITING
Weaning Failure; Muscle Weakness; Mechanical Ventilation Complication; ICU Acquired Weakness; Mobility Limitation
Leticia Maria Defendi Barboza Marson
 2024-09-09 PHASE4
NCT07346677 NOT_YET_RECRUITING
Cancer; Chemotherapy
University of Basrah
 2026-05-11 PHASE2
NCT07274371 ACTIVE_NOT_RECRUITING
Sleep Disturbances in Perimenopause
Saipriya Gowrishankar
 2025-11-06
NCT03877991 UNKNOWN
Pain
Hadassah Medical Organization
 2024-02-19 EARLY_PHASE1
NCT06375850 UNKNOWN
Phlebitis
Hospital Universitario Marqués de Valdecilla
 2022-06-05
NCT06030141 COMPLETED
Phlebitis; Peripheral Venous Catheterization
Kutahya Health Sciences University
 2023-11-15
NCT06151769 UNKNOWN
Pressure Ulcer
TC Erciyes University
 2024-02-18
NCT06156930 COMPLETED
Hemodialysis
TC Erciyes University
 2023-12-06
NCT06972134 COMPLETED
Cholesterol Gallstone Dissolution
University of Duhok
 2023-12-15
NCT04962152 UNKNOWN
Analgesia; Nausea and Vomiting, Postoperative; Itching; Injection Site Reaction; Satisfaction, Patient
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2021-07-07 PHASE4
NCT06437717 COMPLETED
Chronic Rhinosinusitis (Diagnosis)
Mansoura University
 2022-12-01
NCT07060053 COMPLETED
Oral Health Related Quality of Life
Christine Zürcher
 2022-05-04
NCT05326568 COMPLETED
Phlebitis After Infusion
Cukurova University
 2023-06-15
NCT05658367 COMPLETED
Acute Pain; Anxiety; Mastectomy; Massage Therapy; Aromatherapy
Istanbul Medipol University Hospital
 2022-05-17
NCT04620369 COMPLETED
Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Nasal Vestibulitis
Mayo Clinic
 2020-11-13 PHASE3
NCT06216522 COMPLETED
Phlebitis; Thrombophlebitis
National Heart Centre Singapore
 2022-04-12
NCT06327841 COMPLETED
Dental Plaque; Gingivitis; Oral Microbial Colonization
Medical University Innsbruck
 2022-06-21
NCT06375850 Recruiting
Phlebitis
Hospital Universitario Marqués de Valdecilla
 2022-06-05 Not Applicable
NCT04120363 COMPLETED
Caloric Restriction; Exercise; Sleep
Pennington Biomedical Research Center
 2019-09-23 PHASE4
NCT03738176 UNKNOWN
Oral Lichen Planus
Mona Taha Mohammed MD
 2019-12-16 EARLY_PHASE1
NCT04737798 COMPLETED
Gingivitis
Baskent University
 2020-01-02
NCT03826121 COMPLETED
Cognitive Function
Chonbuk National University Hospital
 2017-09-15
NCT02734238 COMPLETED
Caloric Restriction; Exercise
Pennington Biomedical Research Center
 2016-04 PHASE4
NCT01688479 COMPLETED
Postoperative Radiotherapy Breast Cancer
Karolinska University Hospital
 2011-02 PHASE3
NCT00399165 COMPLETED
Contraception
University of Washington
 2006-11 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sesame oil bioactive compounds downregulate pro-inflammatory signaling pathways and scavenge reactive oxygen species, thereby suppressing nuclear factor-kappa B activation and inhibiting inflammatory cytokine secretion. This cellular attenuation of oxidative stress and inflammatory signaling reduces vascular and mucosal tissue injury, directly contributing to its therapeutic efficacy in clinical conditions such as catheter-related phlebitis and gingivitis.

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>).

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Note: Technical data last updated: Sep 1, 2026.