| Sumario: | Background: Cancer is the leading cause of death worldwide. Chemotherapy is an important clinical treatment for cancer. However, the limitation of chemotherapy is its adverse effects on normal cells. Currently, the research focus is on the development of drugs and chemical compounds that have fewer side effects on normal cells. Extracts of Clausena harmandiana (C. harmandiana; Song Fa) root-bark have anticancer effects and is non-toxic to normal cells. Moreover, 7-methoxyheptaphylline, found in the root-bark of Song Fa, has been shown to inhibit the metastasis of breast cancer to the lungs in BALB/c mice. In this Phase I clinical trial, we aimed to investigate the safety of Song Fa in healthy volunteers. Objectives: To evaluate the safety and determine the adverse effects of C. harmandiana root-bark powder (Song Fa) capsules in healthy volunteers. Methods: An open-label, single-arm trial was conducted at the Ubon Ratchathani University Hospital, Thailand, between December 2022 and February 2023. The study enrolled 10 healthy male and 10 healthy female volunteers. Each volunteer orally ingested capsules of C. harmandiana root-bark extract (450 mg per capsule) once daily before breakfast for 14 days, and attended follow-up appointments after 1, 7, and 14 days. Physical examinations, signs and symptoms, hematology, and blood chemistry (e.g., liver function test, lipid profile, renal function test, and electrolytes) were assessed for screening (Day 0), at the beginning of the trial (Day 1), and on Days 7 and 14. After finishing the trial on Day 14, all volunteers were invited to participate in a follow-up session. To evaluate the safety of the C. harmandiana root-bark powder (Song Fa) capsules, each volunteer engaged in a phone interview on Day 30. The results were assessed against the normal range and baseline using repeated-measures ANOVA statistics. Results: At an oral dose of 450 mg/day, C. harmandiana root-bark powder (Song Fa) capsules did not result in serious adverse effects among the healthy volunteers. Participant physical examination results were all within normal ranges. All laboratory tests including hematology, liver and renal functions, lipid profiles, blood sugar levels, and serum electrolytes remained within normal limits. Measurements were taken the day before drug administration and at 1, 7, and 14 days post-dosing. Using repeated measures ANOVA to compare pre-treatment values at a 95% confidence interval, no significant differences were noted, except in fasting blood sugar levels, which showed a deviation from baseline (p < 0.001). However, these levels were within the normal ranges. Conclusion: The study results confirmed that C. harmandiana root-bark powder (Song Fa) capsules are safe in healthy volunteers. Physical health assessment and laboratory results did not differ from normal values.
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