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An Exploratory Clinical Trial of Low-Frequency Therapy for Sarcoidosis

An Exploratory Clinical Trial of Low-Frequency Therapy for Sarcoidosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1011250049
Enrollment
50
Registered
2025-12-03
Start date
2025-12-03
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

salcoidosis salcoidosis

Interventions

Sponsors

Konno Satoshi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with sarcoidosis who are receiving outpatient care or hospitalized at Hokkaido University Hospital or JR Sapporo Hospital between the date of implementation approval and January 31, 2028

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria shall be excluded from the study. Individuals with a history of progressive brain lesions Individuals concurrently receiving vagus nerve stimulation therapy Individuals with a history of severe cardiovascular disease Individuals with a history of glycerin hypersensitivity Pregnant or lactating individuals Individuals with a history of skin hypersensitivity or skin symptoms triggered by metals, etc. Individuals with difficulty ingesting orally Individuals using cardiac pacemakers or implantable cardioverter defibrillators (ICDs) Other individuals deemed unsuitable as research subjects by the principal investigator or co investigator

Design outcomes

Primary

MeasureTime frame
The presence or absence of lesion shrinkage at the treatment site, as evaluated by imaging studies, up to week 52 following low-frequency therapy administration

Secondary

MeasureTime frame
Changes in forced vital capacity and forced expiratory volume in one second measured by pulmonary function tests (pulmonary sarcoidosis) Changes in daily seizure frequency assessed by Holter electrocardiography Changes in biomarkers such as KL6, BNP, ACE, and lysozyme Presence or absence of worsening pulmonary lesions during low-frequency therapy Presence or absence of new lesions in different organs at each evaluation point Correlation between the state of inflammation and the expression status of clinically pathological factors and other analyzed molecules, as well as the presence or absence of disease-related gene variants and their association with the disease state. Correlation between the state of inflammation and the expression status of clinically pathological factors and other analyzed molecules.

Contacts

Public ContactYuichi Kojima

Hokkaido University Hospital

yu1.kojima@pop.med.hokudai.ac.jp+81-117161161

Outcome results

None listed

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