A Phase I Safety Trial for a Chinese Medicine Herbal Formula.

INTERVENTION: Two capsules twice daily taken 4 hours apart containing Nelumbinis folium(3,000mg), Alismatis Rhizoma (25,000mg), Citri reticulatae Pericarpium (3000mg), Citri reticulatae viride Pericarpium (3,000mg), Atractylodis macrocephalae Rhizoma (10,000mg). The mode will be an oral capsule taken daily for 15 days and compliance will be monitored by capsule return and a diary. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Dizziness;Vertigo; ; Dizziness ; Vertigo PRIMARY OUTCOME: To evaluate the safety of a Chinese medicine (CM) Herbal Formula by liver and kidney function, HbA1c, blood glucose and vitamin D3 via blood pathology tests. The side effect profile and the number and severity of serious adverse events will also be monitored. Safety will be considered to not be confirmed if 1 in 10 participants experience serious adverse events from either dose that have a reasonable possible causal relationship to the investigational medical product (IMP).[From baseline to 15 days on the active treatment. Blood tests for liver, kidney, blood glucose, and vitamin D3 will be conducted and compared. The adverse events will be checked via a study‐specific questionnaire and participant self‐reported dairy. A further 15 days on no treatment will be monitored with the same blood tests conducted for safety and adverse events checked via study‐specific questionnaire. Therefore 30 days per participant. ] SECONDARY OUTCOME: To assess safety and tolerability of a TCM Herbal Formula in healthy adults via the quality‐of‐life measure SF‐36. [On day 15 after taking the investigational product and day 30 after not taking the investigational product for 15 days. ] To assess tolerability and safety of a CM Herbal Formula in healthy adults by the number and severity of non‐serious adverse events that have a reasonable possible causal relationship to the IMP. This will be monitored by a study specific questionnaire, clinical examination and diary records. [Day 15 after taking the active investigational product and day 30 after 15 days not taking the investigational product. ] INCLUSION CRITERIA: 1. Healthy adults aged between 18 and 60 years old 2. BMI is equal or greater than 18.5 and below 35