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Adverse Drug Reaction Frequency Investigation of TJ-41

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080225055
Enrollment
3300
Registered
2020-02-07
Start date
2021-10-01
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

TJ-41 is indicated for the following symptoms/conditions of patients having delicate constitution, reduced digestive func-tions, and severe fatigability of limbs: Summer emaciation, reinforcement of physical strength after illness, tuberculosis, anorexia, gastroptosis, cold, hemorrhoid, anal prolapse, uterine prolapse, impotence, hemiplegia, and hyperhidrosis

Interventions

investigational material(s) Generic name etc : Hochuekkito 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-41 is indicated for the following symptoms/conditions of patients having delicate constitution, reduced digestive func-tions, and severe fatigability of limbs: Summer emaciation, reinforcement of physical strength after illness, tuberculosis, anorexia, gastroptosis, cold, hemorrhoid, anal prolapse, uterine prolapse, impotence, hemiplegia, and hyperhidrosis. 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-41 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-41, outcome and outcome date, causal relationship with TJ-41, treatment details for adverse event.

Secondary

MeasureTime frame
other efficacy 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