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Adverse Drug Reaction Frequency Investigation of TJ-43

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080223212
Enrollment
3300
Registered
2016-05-23
Start date
2016-05-23
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

Following symptoms of those patients with weak stomach, loss of appetite and full stomach pit, and those who are easily fatigued, anemic and likely to have cold limbs: Gastritis, gastric atony, gastroptosis, maldigestion, anorexia, gastric pain, vomiting.

Interventions

investigational material(s) Generic name etc : Rikkunshito INN of investigational material : - Therapeutic category code : 52- Chinese medicines Dosage and Administration for Investigational material

Sponsors

Tsumura & Co.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: TJ-43 is indicated for the relief of the following symptoms of those patients with weak stomach, loss of appetite and full stomach pit, and those who are easily fatigued, anemic and likely to have cold limbs: Gastritis, gastric atony, gastroptosis, maldigestion, anorexia, gastric pain, vomiting. 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-43 in the past, or have been 6 months or more since the last dose.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

MeasureTime frame
safety Presence or absence of adverse event, adverse event name, onset date, severity, treatment of TJ-43, outcome and outcome date, causal relationship with TJ-43, treatment details for adverse event.

Secondary

MeasureTime frame
efficacy other Effectiveness; improvement, no change, worse, undecidable Treatment satisfaction: fully satisfactory treatment, almost satisfactory treatment, unsatisfied treatment only, treatment not being carried out, undecidable

Countries

Japan

Outcome results

None listed

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