Multiple clinical trials evaluate the therapeutic potential of thymoquinone across early phase 1 through phase 4 studies, sponsored primarily by academic institutions such as Assiut University, Cairo University, and King Abdulaziz University. These investigations target diverse medical conditions, including gingivitis, oral premalignant lesions, chronic sinusitis with nasal polyposis, diabetes mellitus, diabetic peripheral neuropathy, psoriasis vulgaris, and post-extraction socket preservation. Currently, the recruitment statuses of these trials span completed, actively recruiting, not yet recruiting, and unknown stages.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07765745 | RECRUITING | Radiographic Evaluation; Bone Density; Bone Width; Socket Preservation; Tooth Extraction; Thymoquinone |
Kafrelsheikh University |
2026-02-01 | |
| NCT07391384 | NOT_YET_RECRUITING | Immediate Dental Implant Placement; Jumping Gap; Primary Stability of the Implants |
shaimaa hamdy |
2026-01-21 | |
| NCT07013058 | COMPLETED | Metabolic Syndrome; Elevated Blood Pressure |
Liaquat University of Medical & Health Sciences |
2025-06-15 | |
| NCT07313111 | COMPLETED | Diabetic Peripheral Neuropathy (DPN) |
Hawler Medical University |
2024-07-01 | PHASE4 |
| NCT06070311 | UNKNOWN | Nasal Polyps; Chronic Sinusitis |
Assiut University |
2023-10 | |
| NCT07450807 | COMPLETED | Changes in Human Gut Microbiome in Healthy Adults |
Aysun Tekbaş |
2024-04-02 | |
| NCT06508372 | UNKNOWN | Psoriasis Vulgaris |
Assiut University |
2024-08-01 | |
| NCT05497895 | UNKNOWN | Gingivitis |
King Abdulaziz University |
2022-09 | EARLY_PHASE1 |
| NCT04686461 | UNKNOWN | Keratotic Nodular Size |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2019-10-20 | |
| NCT04852510 | COMPLETED | Polycystic Ovary Syndrome (PCOS) |
Saudi German Hospital - Madinah |
2019-02-01 | PHASE2; PHASE3 |
| NCT03208790 | COMPLETED | Premalignant Lesion |
Cairo University |
2017-09-30 | PHASE2 |
| NCT03776448 | UNKNOWN | Diabetes Mellitus |
Sulaiman AlRajhi Colleges |
2019-01 |
(data from https://clinicaltrials.gov, updated on 2026-08-14)
Mechanism and Biochemical Profile
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>).