Adverse Drug Reaction Frequency Investigation of TJ-17

Adverse Drug Reaction Frequency Investigation of TSUMURA Goreisan Extract Granules for Ethical Use

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031250586

Enrollment

1100

Registered

2025-12-19

Start date

2026-02-02

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

Gastrointestinal and systemic symptoms caused by abnormalities in fluid metabolism

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For patients with thirst and decreased urine output: edema, nephrosis, hangover, acute gastroenteritis, diarrhea, nausea, vomiting, dizziness, gastric fluid retention, headache, uremia, heat exhaustion, and diabetes. The usual adult dose is 7.5 g/day orally in 2 or 3 divided doses before or between meals. Patients who have never taken TJ-17 in the past, or have been 6 months or more since the last dose.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Safety Presence or absence of adverse event, adverse event name, onset date, severity, treatment of TJ-17, outcome and outcome date, causal relationship with TJ-17, treatment details for adverse event.	—

Secondary

Measure	Time frame
Others Efficacy: Improved, Unchanged, Worsened, Not assessable Treatment satisfaction:Treatment was fully satisfactory,Treatment was mostly satisfactory, Only unsatisfactory treatment could be provided,Treatment cannot be considered as having been provided,Not assessable	—

Contacts

Public ContactWataru Wakabayashi

Tsumura & Co.

wakabayashi_wataru@mail.tsumura.co.jp+81-80-4938-3938

Outcome results