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Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

M

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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