Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold

Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold - Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022822

Enrollment

Registered

2016-06-22

Start date

2016-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Healthy volunteers

Interventions

Subjects receive 4 capsules (1200 mg)/day containing ume paste and ginger powder for 8 weeks. Subjects receive 4 placebo capsules (1200 mg)/day for 8 weeks.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Healthy with subjective complaint of intolerance to cold

Exclusion criteria

Exclusion criteria: 1) Taking medicines or functional food that may affect the trial 2) Participation in any clinical trial within 90 days of the commencement of the trial 3) In pregnancy or nursing a child 4) History of severe disease and/or major surgery 5) Judged as ineligible by clinical investigators

Design outcomes

Primary

Measure	Time frame
Change from baseline of mean body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks) - Fingertip (the first joints of 5 fingers) - Toe	—

Secondary

Measure	Time frame
1) Change from baseline of maximum and minimum body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks) - Fingertip (the first joints of 5 fingers) - Toe 2) Change from baseline of mean, maximum, and minimum body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks) - Forearm - Hand - Lower thigh - Foot 3) Change of subjective symptoms of intolerance to cold by a modified VAS (Time frame: 0, 8, 12, and 20 weeks) 4) Change of basal body temperature (Time frame: Everyday throughout the trial) 5) Recovery of body surface temperature after cold water loading test (Subjects immerse their hands in 10 degrees C water for 1 min, and then the body surface temperature of fingers and backs of their hands are measured at 0, 5, and 10 min later by infrared thermography.)(Time frame: Every 4 weeks between 0 and 20 weeks)	—

Measure

Time frame

1) Change from baseline of maximum and minimum body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks) - Fingertip (the first joints of 5 fingers) - Toe 2) Change from baseline of mean, maximum, and minimum body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks) - Forearm - Hand - Lower thigh - Foot 3) Change of subjective symptoms of intolerance to cold by a modified VAS (Time frame: 0, 8, 12, and 20 weeks) 4) Change of basal body temperature (Time frame: Everyday throughout the trial) 5) Recovery of body surface temperature after cold water loading test (Subjects immerse their hands in 10 degrees C water for 1 min, and then the body surface temperature of fingers and backs of their hands are measured at 0, 5, and 10 min later by infrared thermography.)(Time frame: Every 4 weeks between 0 and 20 weeks)

—

Countries

Japan

Contacts

Public ContactFumiko Higashikawa

Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine

fumiko@hiroshima-u.ac.jp082-257-1533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026