Examination of pain relief effect of Goreisan for glossodynia

JRCT ID: jRCTs071200017

Registered date:23/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: glossodynia
• Date of first enrollment: 30/10/2020
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Goreisan treatment

Outcome(s)

Primary Outcome

Self-filled pain scale (VAS)
(Evaluation 12 weeks after administration is the main evaluation point.)

Secondary Outcome

1. VAS
2.Salivary amylase activity
3 Tongue examination (whether the veins in the back of the tongue are inflated)
4. Relation to weather information (pressure)
(Evaluation 4 weeks and 8 weeks after administration is the main evaluation point.)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. For patients undergoing treatment for glossodynia
2. Age: Adult patients aged over 20 years of age at the time of consent acquisition
3. Gender: Any question
4. hospitalization / outpatient: outpatient only
5. Patients who received written consent by their own free will after thorough understanding before participating in this study

Exclude criteria

1.Patients taking Kampo medicines including Goreisan
2.Severe hypertension patients with diastolic blood pressure of 120mmHg or more
3.Patients with severe liver and renal dysfunction
4.Patients with drug hypersensitivity such as allergy
5.Pregnant women and patients who may be pregnant or lactating
6.Patients who participated in another clinical study within 4 months
7.Other patients that the investigator judged to be inappropriate as the study subject

Related Information

• Primary Sponsor: Ayuse Takao