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Examination of the effect of continuous intake of test food on improving weather pain symptoms during daily life and during exposure to artificial low pressure

Examination of the effect of continuous intake of OPC-KMP on improving weather pain symptoms during daily life and during exposure to artificial low pressure - A randomized, double-blind, placebo-controlled, crossover comparative study - Examination of the effect of continuous intake of OPC-KMP on improving weather pain symptoms.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041250153
Enrollment
32
Registered
2025-12-23
Start date
2025-12-23
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

migraine Weather-related pian

Interventions

Subjects will be assigned to two groups and undergo a crossover trial: (1) intake of a placebo food, and (2) intake of a food containing OPC-KMP. Each period will consist of an observation period (27
migraine

Sponsors

Ushida Takahiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Meet all of the following selection criteria 1) Those who have consented to participate in the research (adult men and women 20-64 years old) 2) Weather-related pain holders with moderate headaches 3) Those who can participate in one pre-interview and two exposure experiments on the schedule specified by the researcher 4) Those who can submit the results of the medical examination as needed

Exclusion criteria

Exclusion criteria: Those who violate any of the following exclusion criteria 1) Aichi Medical University student 2) Outpatients at Aichi Medical University Hospital Pain Relief Surgery / Pain Center 3) Persons with drug allergies and food allergies 4) Those who plan to take or may take any new treatment during the study period 5) Those who regularly use health foods and supplements such as foods for specified health use and foods with functional claims that are expected to improve pain 6) Pregnant, lactating and wishing to become pregnant during the study period 7) Those who cannot understand the contents of the questionnaire 8) Others (during medication, treatment, etc.) Persons who are judged by the investigator and the person in charge of research to be inappropriate as participants

Design outcomes

Primary

MeasureTime frame
Pain score during daily life (NRS)

Secondary

MeasureTime frame
Pain score (NRS), sleepiness score (NRS), fatigue score (NRS), discomfort score (NRS), mood score (POMS2), anxiety and depression score (HADS), heart rate, autonomic nervous function, blood pressure, dizziness induction threshold by electrical stimulation of the inner ear, salivary amylase, transcutaneous arterial oxygen saturation (SpO2)

Contacts

Public ContactHiroki Sakurai

Aichi Medical University

hsaku@hm.tokoha-u.ac.jp+81-561-62-3311

Outcome results

None listed

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