None listed
Conditions
Brief summary
The purpose of this phase I open-label safety trial is to assess the safety of a traditional Chinese medicine (TCM) herbal formula, containing Alisma orientale, Prunus armeniaca, Cyperus rotundus and Atractylodes macrocephala, in healthy adults aged 18-60 years old. Twenty participants will be recruited, 10 will receive 1 capsule per day, 10 will receive 2 capsules per day for a 15 day period. We hypothesize that the TCM herbal formula is safe and will not cause serious side effects.
Interventions
A specific Traditional Chinese Medicine (TCM) Herbal Formula consisting of: Alisma orientale rhizome ext. dry 20:1 (12,500 mg), Atractylodes macrocephala root ext. dry 20:1 (5,000 mg), Prunus armeniaca (Semen armeniacae amarum) seed ext. dry 10:1 (1,500 mg), and Cyperus rotundus rhizome ext. dry 10:1 (1,500 mg) per capsule. The dose will be either 1 capsule daily (n=10) or 2 capsules daily (n=10) administered orally in the morning, on an empty stomach 30 minutes before food for 15 days. Monitori
A specific Traditional Chinese Medicine (TCM) Herbal Formula consisting of: Alisma orientale rhizome ext. dry 20:1 (12,500 mg), Atractylodes macrocephala root ext. dry 20:1 (5,000 mg), Prunus armeniaca (Semen armeniacae amarum) seed ext. dry 10:1 (1,500 mg), and Cyperus rotundus rhizome ext. dry 10:1 (1,500 mg) per capsule. The dose will be either 1 capsule daily (n=10) or 2 capsules daily (n=10) administered orally in the morning, on an empty stomach 30 minutes before food for 15 days. Monitoring of the capsules will be conducted by a participant diary and capsule return at 15 days. The participants will then be monitored with no intervention for another 15 days (30 days all together).
Sponsors
Southern Cross University, National Centre for Naturopathic Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy
Exclusion criteria
1. Pregnant or breast-feeding women 2. Anyone with an acute disease 3. History of an un-managed chronic disease 4. Do not speak English 5. Severe mental illness or difficulty communicating 6. Current alcoholism or recreational drug use 7. Anyone taking diabetic medication 8. Bleeding disorders 9. Anyone with stomach ulcer(s) 10. Anyone who gets migraines from physical injury 11. People with dry cracked lips
Outcome results
None listed