Multi-Herb Granule Treatment for Medicinal Use

TSUMURA Ninjin’yoeito Extract Granules for Ethical Use (TJ-108; Tsumura & Co., Tokyo, Japan) is composed of twelve crude drugs (Rehmannia Root, Japanese Angelica Root, Atractylodes Rhizome, Poria Sclerotium, Ginseng, Cinnamon Bark, Polygala Root, Peony Root, Citrus Unshiu Peel, Astragalus Root, Glycyrrhiza, and Schisandra Fruit), and was administered three times daily (3 g each time, 9 g/day) during the 24-week treatment period. The dose of NYT could be reduced to 6 g/day administered twice daily, depending on the subject’s age, body weight, and response to the treatment (e.g., adverse events). For the assessment of adverse events, we used the package insert of NYT and medical opinion to judge whether there was a causal relationship between the treatment and the adverse reaction. Approval was received from the CRB.