Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

Recurrent Aphthous Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122147
• Other study ID #: 87034
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2010
• Last updated: August 1, 2011
• Start date: April 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2010
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrent Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

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 mouthwash
The patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University of Madical Science,Research Center of Mashhad Dental School	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes