Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 1

Conditions: Recurrent Aphthous Stomatitis

Treatments: Drug: chamomilla tincture mouthwash; Drug: placebo mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT01122147

87034

Details and patient eligibility

About

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 .

Enrollment: 30 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

chamomilla tincture mouthwash

Active Comparator group

Description:

Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action

Treatment:

Drug: chamomilla tincture mouthwash

placebo mouth wash

Placebo Comparator group

Description:

placebo mouthwash is produced with the same taste and smell for using in placebo/ control group.

Treatment:

Drug: placebo mouthwash