Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

NCT01122147 | Completed Phase 1

• 1 other identifier: 87034
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Recurrent Aphthous Stomatitis

Keywords

Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  3 months

Study Arms (2)

chamomilla tincture mouthwash

ACTIVE COMPARATOR

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

Drug: chamomilla tincture mouthwash

placebo mouth wash

PLACEBO COMPARATOR

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

Drug: placebo mouthwash

Interventions

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

chamomilla tincture mouthwash

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

placebo mouth wash

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Having the experience of oral aphthae at least once in a month
• Two weeks wash out periods after the last treatment

You may not qualify if:

• History of any systemic disease
• Using drugs which affect immune system
• Pregnancy and breast feeding
• Aphthous related syndromes

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

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

Mashhad, Khorasan Razavi, 91735, Iran

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• seyyed amir seyyedi, DDS-MSc

  mashhad UMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 13, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 2, 2011

Record last verified: 2010-03

Locations

IR (1)