Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain

Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain - Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035870

Enrollment

Registered

2019-10-01

Start date

2019-10-01

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

Oketsu with lower abdominal pain

Interventions

No additional medicine TJ-25 TJ-61

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Patients who have lower abdominal pain in chief complaint and who are recommended for medication by general examination (internal examination, ultrasonic examination) 2) Patients with ECOG-PS 0 or 1 3) Patients whose main organ function is adequately maintained (A) White blood cell count > 3,500 / mm 3, < 12 000 / mm 3 (B) Number of neutrophils > 1,500 / mm 3 (C) Platelet count > 100,000 / mm 3 (D) Hb > 9.0 g / dL (E) AST , ALT < 100 IU / L (F) Creatinine < 1.2 mg / dL

Exclusion criteria

Exclusion criteria: 1) Patients with allergies to traditional Chinese medicine 2) Patients with severe complications (such as heart failure, renal failure, liver failure, hypoactive nutrition) and severe mental illness 3) Patients whose oral ingestion is impossible 4) Patients already receiving prescription of traditional Chinese medicine for the current pain episode 5) In addition, patients judged unsuitable for doctors to safely carry out this study

Design outcomes

Primary

Measure	Time frame
Abdominal pain (VAS scale, dysmenorrhea score) Oketsu seriousness (Oketsu score) For the above, compare scores before treatment and after 28 days	—

Secondary

Measure	Time frame
Cold (cold score) Stiff shoulder (VAS scale) For the above, compare scores before treatment and after 28 days	—

Countries

Japan

Contacts

Public ContactNobuhisa Yoshikawa

Nagoya University School of Medicine Department of obstetrics and gynecology

n-yoshikawa@med.nagoya-u.ac.jp052-744-2261

Outcome results

None listed

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