Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01122147

Enrollment

Registered

2010-05-13

Start date

2010-04-30

Completion date

2011-02-28

Last updated

2011-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Aphthous Stomatitis

Keywords

Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla

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 .

Interventions

DRUGchamomilla 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

DRUGplacebo mouthwash

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis	3 months	This study evaluates the fluid extract from Chamomilla recutita's effectiveness on healing rate of aphthous stomatitis, and reducing ulcer size

Secondary

Measure	Time frame	Description
This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer	3 months	In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the frequency of ulcers monthly

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026