NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041210100

Registered date:15/11/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNueropathic pain
Date of first enrollment15/11/2021
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)Take the test food 6 tablets daily (2 tablets each morning, noon, and night) with water or hot water for 3 months.

Outcome(s)

Primary OutcomePain intensity(Numerous Rating Scale)
Secondary OutcomePain Disability Scale(PDAS) Hospital Anxiety and Depression Scale(HADS) Pain Catastrophizing Scale(PCS) Pain Self Efficacy questionnaire(PSEQ) Athenes Insomnia Scale(AIS) Health Related Quality of Life (EQ-5D)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Yuki Terajima
Address 1-1, Yazakokarimata, Nagakute, Aichi Aichi Japan 480-1195
Telephone +81-561-62-5004
E-mail y.terajima@aichi-med-u.ac.jp
Affiliation Aichi Medical University
Scientific contact
Name Takahiro Ushida
Address 1-1, Yazakokarimata, Nagakute, Aichi Aichi Japan 480-1195
Telephone +81-561-62-5004
E-mail ushidat@aichi-med-u.ac.jp
Affiliation Aichi Medical University Hospital