Herbal medicine for relief of oral mucositis.

Formulation and clinical trial randomized double-blind herbal medicines with prophylactic and curative purposes of oral mucositis (Phase I)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-8rqy3z

Enrollment

Unknown

Registered

2017-04-04

Start date

2017-02-09

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Oral mucositis. Health patients.

Interventions

Twenty healthy subjects are randomly divided into two groups: I (n = 10) patients who receive medicine in oral mouthwash solution at a concentration A, which corresponds to 20mg/ml of curcuminoids (sa

Drug

E02.190.755

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Healthy volunteer, both genders; nonsmokers; over 18 years.

Exclusion criteria

Exclusion criteria: Patients with severe systemic disease; historic allergy; smokers; historic aphthous ulcers.

Design outcomes

Primary

Measure	Time frame
The proposed phytotherapy, in the two concentrations used, will not cause changes in the oral mucosa (erythema, ulcerations, pain, desquamation, cellular cytotoxicity and laboratory tests of the hepatic and renal function) in all the healthy volunteers, being verified through the physical examination of the mouth , Inspection, palpation, photographic record, cytological evaluation of buccal scraping and laboratory tests to evaluate renal and hepatic function. The evaluations will be performed twenty-four hours before the beginning of the mouthwash with the herbal remedy, on the fifth and tenth days, and five days after the end of the medication use.;The proposed phytotherapic, in the two concentrations tested, did not cause clinical alterations and adverse effects in the patients, nor cytological and / or cytotoxic changes in the epithelial lining of the buccal mucosa in any of the clinical moments evaluated. The phytotherapic also did not provide inflammation or tissue aggression in the oral mucosa. In addition, the herbal medicine did not alter the hematological, hepatic, renal and glycemic parameters of the patients.	—

Measure

Time frame

The proposed phytotherapy, in the two concentrations used, will not cause changes in the oral mucosa (erythema, ulcerations, pain, desquamation, cellular cytotoxicity and laboratory tests of the hepatic and renal function) in all the healthy volunteers, being verified through the physical examination of the mouth , Inspection, palpation, photographic record, cytological evaluation of buccal scraping and laboratory tests to evaluate renal and hepatic function. The evaluations will be performed twenty-four hours before the beginning of the mouthwash with the herbal remedy, on the fifth and tenth days, and five days after the end of the medication use.;The proposed phytotherapic, in the two concentrations tested, did not cause clinical alterations and adverse effects in the patients, nor cytological and / or cytotoxic changes in the epithelial lining of the buccal mucosa in any of the clinical moments evaluated. The phytotherapic also did not provide inflammation or tissue aggression in the oral mucosa. In addition, the herbal medicine did not alter the hematological, hepatic, renal and glycemic parameters of the patients.

—

Secondary

Measure	Time frame
Not applicable for this study phase I.	—

Countries

Brazil

Contacts

Public ContactElismauro Mendonça

Hospital Araujo Jorge da Associação de Combate ao Câncer em Goiás

elismaur@ufg.br+55 (62) 3243 7237

Outcome results

None listed

Source: REBEC (via WHO ICTRP)