None listed
Conditions
Brief summary
Dantonic Pill (DP) is a pharmaceutical product derived from medicinal herbs Salvia miltiorrhiza and Panax notoginseng. DP has been registered in China for the prevention and management of atherosclerotic cardiovascular disease for over ten years. Clinical trial studies in China have demonstrated that DP has few side effects and Asian people are well tolerant of the DP therapy. To date, DP is also availbale in many herb shops in Australia and however, the data concerning the tolerance and side effects of this product in Western population are limited. This project study aims to investigate the tolerance and general physiological responses to DP in Western people, through assessment of the symptems, blood pressure, electrocardiogram (ECG), bloof cell count, blood lipids and glucose, and liver and renal function in healthy adult Westerners folllowing a single dose of DP therapy.
Interventions
The Dantonic Pill (DP) is derived from traditional Chinese herbal medicines, Salvia miltiorrhiza, Panax notoginseng and Borneol, and is used in China for the prevention and management of atherosclerosis-associated cardiovascular disease. This project aims to assess the tolerance and physiological response to DP in 56 healthy adult Westerners. The participant (volunteer) will orally take a single dose of Dantonic Pill at 60, 80, 100, 120, 130, 140, 150, 160, 170, or 180 pills (25mg/pill), with 4-
The Dantonic Pill (DP) is derived from traditional Chinese herbal medicines, Salvia miltiorrhiza, Panax notoginseng and Borneol, and is used in China for the prevention and management of atherosclerosis-associated cardiovascular disease. This project aims to assess the tolerance and physiological response to DP in 56 healthy adult Westerners. The participant (volunteer) will orally take a single dose of Dantonic Pill at 60, 80, 100, 120, 130, 140, 150, 160, 170, or 180 pills (25mg/pill), with 4-6 subjects for each dose group. The symptoms, blood pressure, and electrocardiogram (ECG) will be assessed before and at 1.5 hours, 8 hours, 24 hours and 7 days after the Dantonic therapy. Blood and urine samples will also be collected for the laboratory assessments.
Sponsors
R&D Institute, Tasly Pharmaceutical Company
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
- Healthy subjects of non-Asian background - BMI(body mass index) between 19 to 29 - Normal physical condition without any significant disease in heart, lung, and other organs - Satisfactory test results of liver and kidney function, blood and urine testing - Signed informed consent
Exclusion criteria
- History of clinically significant cardio-cerebral disease, organic disease of blood system, nervous and other systems - Pregnant or nursing mother - - On-going other treatment or medicine that may interfere with the actions of Dantonic Pill or administration of similar medication within 2 weeks of entering study - Blood donor in recent 3 months - Have taken part in other clinical trial in recent 3 months - Extreme tobacco smoker (>20 cigarettes per day) and alcohol user (>2 standard drinks per day) - Known hypersensitivity to the ingredients of Dantonic Pill or other relevant drug allergy
Outcome results
None listed