Adverse Drug Reaction Frequency Investigation of TJ-43
- 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.
- Registration Number
- JPRN-jRCT1080223212
- Lead Sponsor
- Tsumura & Co.
- Brief Summary
Safety analysis was performed for 3,117 cases; among these, 38 reported the occurrence of ADRs, including abnormal laboratory values, after TJ-43 administration. The ADR frequency rate was 1.2%, and the major ADRs were hypokalemia and nausea, which were 0.2% each, and upper abdominal pain, diarrhea, alanine aminotransferase increase, aspartate aminotransferase increase, blood pressure increase, pruritus, and hypertension, which were 0.1% each.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 3300
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.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>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 Outcome Measures
Name Time Method efficacy<br>other<br>Effectiveness; improvement, no change, worse, undecidable<br>Treatment satisfaction: fully satisfactory treatment, almost satisfactory treatment, unsatisfied treatment only, treatment not being carried out, undecidable