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NCT Number: NCT01122147

Clinical Evaluation of Fluid Extract of Chamomilla Tincture for 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 .

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Key information

Conditions

Recurrent Aphthous Stomatitis Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mashhad University of Madical Science,Research Center of Mashhad Dental School

Mashhad, Razavi Khorasan Province, 91735, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chamomilla tincture mouthwash

Drug

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

Drug

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

Primary outcomes

  1. protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis

    Time frame: 3 months

    This study evaluates the fluid extract from Chamomilla recutita's effectiveness on healing rate of aphthous stomatitis, and reducing ulcer size

Secondary outcomes

  1. This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer

    Time frame: 3 months

    In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the frequency of ulcers monthly

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 13, 2010
Registry last updated
Aug 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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