Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

NCT ID: NCT01122147

Last Updated: 2011-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-02-28

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 .

Detailed Description

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Conditions

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Recurrent Aphthous Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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chamomilla tincture mouthwash

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

Group Type ACTIVE_COMPARATOR

chamomilla tincture mouthwash

Intervention Type 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 mouth wash

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

Group Type PLACEBO_COMPARATOR

placebo mouthwash

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

placebo mouthwash

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mashhad University of Medical Science

Principal Investigators

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seyyed amir seyyedi, DDS-MSc

Role: PRINCIPAL_INVESTIGATOR

mashhad UMS

Locations

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

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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87034

Identifier Type: -

Identifier Source: org_study_id

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