Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

Phase 1 Evaluation of Therapeutic Effect of Chamomilla Tincture Mouthwash on Oral Aphthae

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 .

Study Overview

• Status: Completed
• Conditions: Recurrent Aphthous Stomatitis
• Intervention / Treatment: Drug: chamomilla tincture mouthwash; Drug: placebo mouthwash

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khorasan Razavi
    • Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
      • Mashhad University of Madical Science,Research Center of Mashhad Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: chamomilla tincture mouthwash; Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action	Drug: chamomilla tincture mouthwash; The patient is directed to mouth wash chamomilla tincture lightly three times a day,ten drops for each time,until ulcers completely heal
PLACEBO_COMPARATOR: placebo mouth wash; placebo mouthwash is produced with the same taste and smell for using in placebo/ control group.	Drug: placebo mouthwash; The patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Principal Investigator: seyyed amir seyyedi, DDS-MSc, mashhad UMS

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (ESTIMATE): May 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 2, 2011
• Last Update Submitted That Met QC Criteria: August 1, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Aphthous
• Other Study ID Numbers: 87034