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Evaluation of anti-aphthous activity of mouthwash of tobacco leaves in patients with oral aphthous

Clinical trial comparison of anti-aphthous effect of mouthwash of tobacco leaves and placebo in patients with oral aphthous

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014112420071N1
Enrollment
60
Registered
2015-11-06
Start date
2015-05-05
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minor aphthous. Aphthous stomatitis (major)(minor)

Interventions

Intervention 1: Administration of a mouthwash from decoction of leaves of tabacco which must be gargled as 10 ml of mouthwash 3 times a day. Intervention 2: Placebo is prepared in similar container in
Treatment - Drugs
Placebo
Administration of a mouthwash from decoction of leaves of tabacco which must be gargled as 10 ml of mouthwash 3 times a day.
Placebo is prepared in similar container including distilled water with approved color additives which looked the same as the tobacco mouthwash and must be gargled as 10 ml of mouthwash 3 times a day.

Sponsors

Siavash Vaziri
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are as follows: men and women aged 15–65 years old; willingness to participate and sign the informed agreement forms; patients with 1 to 5 aphthous ulcers (less than 48 hours’ duration); an anticipation that their ulcers normally take 5 or more days to resolve without treatment; ulcers must be in positions simply accessible for evaluation and treatment; patients with normal sense of pain and exclusion criteria are the following: a known history of severe drug hypersensitivities; pregnancy or lactation; ulcers as a manifestation of a systemic disease process, including Behçet disease, serious anemia Crohn’s disease, ulcerative colitis, or acquired immune deficiency syndrome; simultaneous clinical conditions which represent a health risk to the subjects, such as severe heart, liver, or kidney disorder; treatment with NSAIDs drugs, systemic steroids or other immunomodulatory agents.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Ulcer size. Timepoint: 5 days. Method of measurement: Millimeter.;Pain level. Timepoint: 5 days. Method of measurement: Visual analog scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSiavash Vaziri

Department of Infectious Disease, Imam Reza Hospital

vaziri15@yahoo.com+98 83 3835 0271

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026