Preparation an oral gel-made from thymoquinone (TQ), and clinical study investigating the efficacy of it on patients with aphtha

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016100914106N5

Enrollment

Registered

2017-09-12

Start date

2017-08-21

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. Recurrent oral aphthae

Interventions

Intervention 1: Experimental group: In this group,28 patients will be received 10% Pomegranate gel. The period for use of the product will be twice a day for a period of one month. Intervention 2: Con

they actually receive the placebo.

Treatment - Drugs

Experimental group: In this group,28 patients will be received 10% Pomegranate gel. The period for use of the product will be twice a day for a period of one month.

Control group: 28 patients will be received placebo. The placebo gels contain all the components of the intervention group gel except for the pomegranate extract

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient inclusion criteria include: possessing aphtatous ulcer; patients without systemic diseases, hypersensitivity history; smoking habits or alcoholism; pregnancy and lactation; orthodontic instruments. Patient exclusion criteria include: Drug usage or any treatment occurring before dental treatment.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of healing. Timepoint: healing measurement will be done twice per month. Method of measurement: quantitative and qualitative assays.;Size of lesion. Timepoint: size of lesion measurement will be done twice per month. Method of measurement: quantitative and qualitative assays.;Pain in lesion. Timepoint: pain measurement in lesion will be done twice per month. Method of measurement: quantitative and qualitative assays.;Erythema. Timepoint: erythema evaluation will be done twice per month. Method of measurement: quantitative and qualitative assays.	—

Measure

Time frame

Duration of healing. Timepoint: healing measurement will be done twice per month. Method of measurement: quantitative and qualitative assays.;Size of lesion. Timepoint: size of lesion measurement will be done twice per month. Method of measurement: quantitative and qualitative assays.;Pain in lesion. Timepoint: pain measurement in lesion will be done twice per month. Method of measurement: quantitative and qualitative assays.;Erythema. Timepoint: erythema evaluation will be done twice per month. Method of measurement: quantitative and qualitative assays.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Tahvilian

School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran

rtahvilian@kums.ac.ir+98 83 3427 6489

Outcome results

None listed

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