Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

Phase 1

Completed

• Conditions: Recurrent Aphthous Stomatitis
• Interventions: Drug: chamomilla tincture mouthwash; Drug: placebo mouthwash

• Registration Number: NCT01122147
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's safety and effectiveness in treatment of aphthous stomatitis .

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-04
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-13
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Confirmation of clinical diagnosis of aphthae

• Having the experience of oral aphthae at least once in a month
• Two weeks wash out periods after the last treatment

Exclusion Criteria

• History of any systemic disease
• Using drugs which affect immune system
• Pregnancy and breast feeding
• Aphthous related syndromes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chamomilla tincture mouthwash	chamomilla tincture mouthwash	Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action
placebo mouth wash	placebo mouthwash	placebo mouthwash is produced with the same taste and smell for using in placebo/ control group.

Primary Outcome Measures

Name	Time	Method
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis	3 months	This study evaluates the fluid extract from Chamomilla recutita's effectiveness on healing rate of aphthous stomatitis, and reducing ulcer size

Secondary Outcome Measures

Name	Time	Method
This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer	3 months	In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the frequency of ulcers monthly

Trial Locations

Locations (1)

Mashhad University of Madical Science,Research Center of Mashhad Dental School; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of