Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001012268
Ethics application status
Approved
Date submitted
28/10/2009
Date registered
23/11/2009
Date last updated
19/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Tolerance and Physiological Responses to the Modern Chinese Medicine “Dantonic Pill” in a Western Population
Scientific title
Tolerance and Physiological Responses to "Dantonic Pill" Therapy in a Western Population in the Prevention of Atherosclerosis
Secondary ID [1] 1124 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects of Chinese medicine on healthy human volunteers 252072 0
Condition category
Condition code
Alternative and Complementary Medicine 252277 252277 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241467 0
Other interventions
Intervention code [2] 241584 0
Prevention
Comparator / control treatment
compared before and after the Dantonic therapy and between different dose-groups
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253147 0
The symptom, blood pressure, and ECG will be assessed by the investigator (Drs.) at the Alfred hospital (Melbounre).
Timepoint [1] 253147 0
At 0, 1.5 hours, 8 hours, 24 hours, and 7 days folowing the Dantonic therapy
Primary outcome [2] 253178 0
Full blood count, blood lipids, blood and urine glucose, blood aminotransterases and bilirubin, and blood urine nitrogen and creatinine will be assessed by the pathology laboratory at the Alfred hospital (Melbounre).
Timepoint [2] 253178 0
At 0 and 24 hours following the Dantonic therapy
Secondary outcome [1] 262046 0
Blood levels of soluble intercellular adhesion molecule -1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) will be assessed by enzyme-linked immunostaining assay (ELISA).
Timepoint [1] 262046 0
AT 0 and 24 hours follwoing the Dantonic therapy
Secondary outcome [2] 262099 0
Blood and urine levels of phenolic acids, major bioactive compounds in Dantonic Pill will be assessed by a high performance liquid chromatography (HPLC) assay.
Timepoint [2] 262099 0
At 0, 1.5 hours, 8 hours, 24 hours, and 7 days follwoing the Dantonic therapy

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a nonrandomised trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a nonrandomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243939 0
Government body
Name [1] 243939 0
International Collaboration Grant
Country [1] 243939 0
China
Primary sponsor type
Commercial sector/Industry
Name
R&D Institute, Tasly Pharmaceutical Company
Address
2 Pujihe East Road, Beichen District, Tianjin 300410
Country
China
Secondary sponsor category [1] 251294 0
University
Name [1] 251294 0
Monash University Medical School
Address [1] 251294 0
Commercial Road, Prahran, Melbourne, Victoria 3181
Country [1] 251294 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244053 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 244053 0
85 Commercial Road, Prahran, Melbourne, Vic 3181
Ethics committee country [1] 244053 0
Australia
Date submitted for ethics approval [1] 244053 0
04/11/2009
Approval date [1] 244053 0
04/03/2010
Ethics approval number [1] 244053 0
Project 408-09

Summary
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.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 30430 0
Address 30430 0
Country 30430 0
Phone 30430 0
Fax 30430 0
Email 30430 0
Contact person for public queries
Name 13677 0
Shanhong Ling
Address 13677 0
Monash University Medical School
Commercial Road
Prahran, Melbourne
Victoria 3181
Country 13677 0
Australia
Phone 13677 0
+61 3 9903 0615
Fax 13677 0
+61 3 9903 0018
Email 13677 0
[email protected]
Contact person for scientific queries
Name 4605 0
Shanhong Ling
Address 4605 0
Monash University Medical School
Commercial Road
Prahran, Melbourne
Victoria 3181
Country 4605 0
Australia
Phone 4605 0
+61 3 9903 0615
Fax 4605 0
+61 3 9903 0018
Email 4605 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.