NCT04385979

Curcumin and Nanocurcumin in Oral Aphthous Ulcer

Completed NA Last updated 13 May 2020

What this trial tests

NA trial testing Gel in Recurrent Aphthous Ulcer in 48 participants. Completed in 1 March 2020.

Timeline

15 July 2018

Primary endpoint
1 January 2019

1 March 2020

Quick facts

Lead sponsor	Shahid Beheshti University of Medical Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	15 July 2018
Primary completion	1 January 2019
Estimated completion	1 March 2020
Sites	1 location across Iran

Drugs / interventions tested

• Gel

Conditions studied

• Recurrent Aphthous Ulcer — all drugs for Recurrent Aphthous Ulcer →
• Recurrent Aphthous Stomatitis — all drugs for Recurrent Aphthous Stomatitis →

Sponsor

Shahid Beheshti University of Medical Sciences

Who can join

Eligibility, any sex, with Recurrent Aphthous Ulcer or Recurrent Aphthous Stomatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recurrent aphthous ulcer is a painful inflammatory lesion with a high prevalence. Since the etiology is not clear, several strategies have been proposed to reduce pain and severity of its symptoms. Today, curcumin is considered as an herbal medicine with anti-inflammatory properties. Treatment or control of various inflammatory diseases has been proposed, but its low solubility in water has reduced bioavailability, while the use of nanoparticle pharmaceutical techniques has been able to solve these problems. Therefore, the aim of the present study was to evaluate the clinical efficacy of a new topical curcumin gel with nano-technology and compare it with 2% curcumin gel in patients with recurrent aphthous ulcers.

This randomized clinical trial was performed on 48 patients assigned to two groups (nano-curcumin gel) and (curcumin gel). Before treatment, the size of the wound and VAS were measured. After intervention, the two variables were measured again on the fourth and seventh days , then the amount of improvement was quantitatively and qualitatively compared in the two groups and a significant level of less than 0.05 was considered.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Foundations of gastrointestinal-based drug delivery and future developments.
   Chu JN, Traverso G. · · 2022 · cited 136× · PMID 34785786 · DOI 10.1038/s41575-021-00539-w
2. Advances in Nanocarrier Systems for Overcoming Formulation Challenges of Curcumin: Current Insights.
   Jacob S, Kather FS, Morsy MA, Boddu SHS, et al · · 2024 · cited 46× · PMID 38668166 · DOI 10.3390/nano14080672
3. Reconnoitering the Therapeutic Role of Curcumin in Disease Prevention and Treatment: Lessons Learnt and Future Directions.
   Sivani BM, Azzeh M, Patnaik R, Pantea Stoian A, et al · · 2022 · cited 26× · PMID 35888763 · DOI 10.3390/metabo12070639
4. Harnessing Nature's Toolbox: Naturally Derived Bioactive Compounds in Nanotechnology Enhanced Formulations.
   Sanjai C, Gaonkar SL, Hakkimane SS. · · 2024 · cited 10× · PMID 39494011 · DOI 10.1021/acsomega.4c07756
5. Advanced Pharmaceutical Nanotechnologies Applied for Chinese Herbal Medicines.
   Li J, Zhang YL, Jin T, Jin Z, et al · · 2025 · cited 7× · PMID 40538293 · DOI 10.1002/advs.202500167