Examination of pain relief effect of Goreisan for glossodynia

Not Applicable

Recruiting

• Conditions: glossodynia

• Registration Number: JPRN-jRCTs071200017
• Lead Sponsor: Ayuse Takao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-filled pain scale (VAS)<br>(Evaluation 12 weeks after administration is the main evaluation point.)

Secondary Outcome Measures

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