preliminary
clinical study has been successfully completed in the U.S. for TJ-114 (Tsumura's
version of the traditional formula Sairei-to). In 1991 Tsumura was granted the first ever Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA) for an herbal medicine. Subsequently, between June 1992 and December 1993, an open-label trial was conducted with the University of Utah and the University of California at Los Angeles (UCLA) to determine the efficacy, tolerability and safety of TJ-114, a slow-acting antirheumatic drug.
Thirty ambulatory patients age 18 or over suffering from active RA were selected for inclusion in the study and were treated with increasing dosages of TJ-114 to a maximum of 130 mg/kg/day for 24 weeks. Urinalysis and blood tests were then conducted every three weeks, as well as general disease assessments and evaluations of joint tenderness, swelling and pain on motion. Patients were carefully monitored in case side effects or adverse reactions occurred. Additionally, patients carried out self-assessments to evaluate morning stiffness and overall disease activity, and were asked to describe any new symptoms.
To analyze a patient's response, the following six points were evaluated:
- Joint tenderness and pain
- Joint swelling
- Westergren erythrocyte sedimentation rate
(ESR)
- Morning stiffness
- Physician's general assessment