Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

Study Overview
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Brief Summary
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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 .

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

Conditions
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Recurrent Aphthous Stomatitis

Intervention / Treatment
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* Drug: chamomilla tincture mouthwash
* Drug: placebo mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla