NCT04476420 is a Phase 3 clinical trial of Nigella sativa oil in Oral Submucous Fibrosis, sponsored by Ziauddin University.

Who is sponsoring NCT04476420?

NCT04476420 is sponsored by Ziauddin University.

What drugs are being tested in NCT04476420?

Interventions in NCT04476420: Nigella sativa oil, Betamethasone Valerate.

What condition does NCT04476420 study?

NCT04476420 studies Oral Submucous Fibrosis.

Is NCT04476420 still recruiting?

NCT04476420 is currently completed. Last updated 15 March 2022.

Last reviewed 2022-03-15 · How we verify

NCT04476420

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Completed Phase 3 Last updated 15 March 2022

What this trial tests

Phase 3 trial testing Nigella sativa oil in Oral Submucous Fibrosis in 39 participants. Completed in 30 September 2021.

Timeline

11 February 2021

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	Ziauddin University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	11 February 2021
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	1 location across Pakistan

Drugs / interventions tested

Nigella sativa oil — full drug profile →
Betamethasone Valerate (BETAMETHASONE VALERATE) — full drug profile →

Conditions studied

Oral Submucous Fibrosis — all drugs for Oral Submucous Fibrosis →

Sponsor

Ziauddin University

Who can join

18 and older, any sex, with Oral Submucous Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Oral submucous fibrosis (OSMF) is a potentially malignant condition mainly characterized by inflammation and fibrosis of the submucosal tissues leading to marked rigidity and reduced opening of the jaws. OSMF has a multifactorial etiology but areca nut consumption is considered to be the most consistent factor in its pathogenesis. There is no definitive treatment available for treating OSMF. Conventional management involves physiotherapy exercises and treating the disease with certain medications such as steroids and homeopathic medications.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Recent Findings on Thymoquinone and Its Applications as a Nanocarrier for the Treatment of Cancer and Rheumatoid Arthritis.
Pal RR, Rajpal V, Rajpal V, Singh P, et al · · 2021 · cited 21× · PMID 34067322 · DOI 10.3390/pharmaceutics13060775

Verify or expand the search:

Other trials of Nigella sativa oil

Trials testing the same drug.

NCT05541185 — Effects of Nigella Sativa Oil on Pain Intensity and Physical Functions in Patients With Knee Osteoarthritis · NA · completed
NCT04401202 — Nigella Sativa in COVID-19 · Phase 2 · completed

Other recruiting trials for Oral Submucous Fibrosis

Currently open trials in the same condition.

NCT06639009 — Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis · NA · recruiting

Other Ziauddin University trials

Trials by the same sponsor.

NCT07325981 — Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adheren · NA · not yet recruiting
NCT06871904 — Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis · Phase 1, PHASE2 · completed
NCT07097441 — To Observe Haemodynamic Parameters Including, Heart Rate, Blood Pressure, Respiratory Rate , and Oxygen Saturation, With · Phase 1, PHASE2 · completed
NCT07232316 — Effect of Integrated Neuromuscular Inhibition Technique on Scapular Dyskinesia Type 2 · NA · completed
NCT07079514 — Effect of Magnesium Sulfate on Hemodynamics on Laparoscopic Cholecystectomy Patients · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04476420 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ziauddin University
Last refreshed: 15 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04476420.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing