Tetanus-diphtheria(Td) vaccine effect on recurrent minor oral aphthous.

Tetanus diphtheria(Td) booster vaccine effect on recovery and relapse of recurrent minor oral aphthous.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201501213989N1

Enrollment

Registered

2016-01-03

Start date

2015-02-20

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

Recurrent Aphthous stomatitis( minor). Recurrent oral aphthae

Interventions

Intervention 1: In the intervention group, one mg of oral colchicine daily for 5 days plus a booster dose of ,Tetanus diphtheria(Td) vaccine is injected right deltoid region. In case of recurrent aph

Treatment - Drugs

In the intervention group, one mg of oral colchicine daily for 5 days plus a booster dose of ,Tetanus diphtheria(Td) vaccine is injected right deltoid region. In case of recurrent aphthous, oral col

In the control group one milligram oral colchicine daily for five days plus a half cc of vitamin B6 as a placebo in right deltoid area injected. In case of recurrent aphthous, oral colchicine one mg d

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 20 to 60 years old patients; who have 1 to 3 minor(1-8 millimeters) oral aphthous; with at least one relapse per month, Exclusion criteria :establishment of anemia; HIV or Behcet's syndrome ; recipients of tetanus-diphtheria(Td) vaccine in the last five years

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Aphthous remission after treatment. Timepoint: At the beginning and end of the study. Method of measurement: Based on the judgment of those who have studied .Complete remission, partial remission, non-recovery.;The interval between the occurrence of aphthous. Timepoint: 180 days. Method of measurement: One day(24 hours).;The number of aphthous in each recurrence. Timepoint: 180 days. Method of measurement: The number of aphthous.;Measuring pain intensity. Timepoint: 180 days. Method of measurement: A score of 0 to ten according to one's own judgment.;Size of aphthous. Timepoint: 180 days. Method of measurement: milimeter.	—

Measure

Time frame

Aphthous remission after treatment. Timepoint: At the beginning and end of the study. Method of measurement: Based on the judgment of those who have studied .Complete remission, partial remission, non-recovery.;The interval between the occurrence of aphthous. Timepoint: 180 days. Method of measurement: One day(24 hours).;The number of aphthous in each recurrence. Timepoint: 180 days. Method of measurement: The number of aphthous.;Measuring pain intensity. Timepoint: 180 days. Method of measurement: A score of 0 to ten according to one's own judgment.;Size of aphthous. Timepoint: 180 days. Method of measurement: milimeter.

—

Secondary

Measure	Time frame
Injection site reactions. Timepoint: Fifteen days after injection. Method of measurement: Physical examination in case of complications.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSharam Habibzadeh

Ardabil University of Medical science(ARUMS)

s.habibzadeh@arums.ac.ir ,shahramhabibzadeh@yahoo.com+98 45 3351 4390

Outcome results

None listed

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