A study investigating the effect of Java ginger extract in patients with refractory leg neuropathic pai

Not Applicable

Recruiting

• Conditions: ueropathic pain; pain,; D009437

• Registration Number: JPRN-jRCTs041210100
• Lead Sponsor: shida Takahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Those who can provide written consent for participation in the study.
2) Age: 20 to 80 years old (at the time of obtaining consent)
3) Gender: Males and females who reside in Japan and can communicate in Japanese
4) Patients who have been diagnosed with intractable neuropathic pain

Exclusion Criteria

1) Patients with current or previous diabetes mellitus
2) Those who are currently being treated with some kind of anticancer drug
3) Those who are planning to take or may take some kind of new therapeutic drug during the study period
4) Those who have a current or history of drug allergy or food allergy
5) Those who are being treated for drug dependence or drug abuse or have a history of drug dependence or drug abuse
6) Persons who regularly use health foods and supplements such as food for specified health use and food with functional properties that are expected to improve pain
7) Those who are pregnant or lactating, or those who wish to become pregnant during the study period
8) Those who have difficulty in oral intake
9) Those who are participating in other clinical trials or within one month of the end of the study
10) Those who are judged inappropriate for participation in this study by the study investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity(Numerous Rating Scale)

Secondary Outcome Measures

Name	Time	Method
Pain Disability Scale(PDAS)<br>Hospital Anxiety and Depression Scale(HADS)<br>Pain Catastrophizing Scale(PCS)<br>Pain Self Efficacy questionnaire(PSEQ)<br>Athenes Insomnia Scale(AIS)<br>Health Related Quality of Life (EQ-5D)