Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000007639
Ethics application status
Not yet submitted
Date submitted
12/12/2013
Date registered
3/01/2014
Date last updated
17/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improved treatment of type 2 diabetes mellitus by improving the splenic functions and gastro intestinal tract using naturally occurring bioactive compounds
Scientific title
Improved treatment of Type 2 Diabetes by improving the splenic function and intestinal tract using ANIVINA, a novel drug composition based on naturally occurring bioactive compounds
Secondary ID [1] 283764 0
"Nil"
Universal Trial Number (UTN)
U1111-1151-2885
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Splenic and gastro intestinal disorder in Type 2 Diabetes Mellitus 290737 0
gastrointestinal disorder 290738 0
Diabetes mellitus 290739 0
Metabolic diseases 290740 0
Condition category
Condition code
Metabolic and Endocrine 291099 291099 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels. The vast majority of cases of diabetes fall into two broad etiopathogenetic categories of type 1 and type 2. In type 1 diabetes, the cause is an absolute deficiency of insulin secretion. In the other, the much more prevalent category of type 2 diabetes, the cause is a combination of resistance to insulin action and an inadequate compensatory insulin secretory response. The type 2 diabetes is thus, characterized by both fasting and postprandial hyperglycemia. In both situations, the degree of hyperglycemia is determined by the difference between the amount of glucose entering and leaving the circulation. With a view on the intimate relationship of pancreas and splenic hilum in particular and with the spleen in general, involvement of the spleen in asthenic pancreas can lead to the insulin production of and secretion from pancreas injured. Type 2 diabetes is a chronic metabolic disease that has a significant impact on the health, quality of life, and life expectancy of patients. Therefore, the effectiveness of treatment of spleen and pancreas based splanchnic approach has thoroughly been studied in controlling and treating the chronic hyperglycemia of type 2 diabetes. In this study, a kind of 500 mg pill was prepared and named as ANIVINA, and described as below:
- ANIVINA was prepared from 120 mg of dried extract powder of Rhizoma Homalomenae, 120 mg of dried extract powder of Ananas comosus rhizome 120 mg of dried extract powder of Dioscorea opposite rhizome, 120 mg of dried extract powder of Croton tonkinensis and 50 mg of extract powder of Pueraria thomsonii Benth in a form of viscous solution, and then hand - rolled into pills of around 500 mg, each.
ANIVINA is a combination of bioactive compounds that inhibits antioxidants activity, anti-inflammatory effects and potential use in conditions related to improving the splenic function as well as intestinal tract.
Ninety four patients with chronic hyperglycemia of diabetes who come from different parts of Vietnam, were randomly selected and included in the study. Their age range was 52–85 years. All patients were desperately suffering from disease of type 2 diabetes and many of them were hospitalized and measured value of HbA1C over prolonged period of time. of which the shortest disease history was 5 years and the longest was 14 years taking ANIVINA orally with a single dose of 1200 mg/kg daily for 93 days. ANIVINA was in the form of pill which was prepared from dried extract powder of Rhizoma Homalomenae, dried extract powder of Ananas comosus rhizome, dried extract powder of Croton tonkinensis and dried extract powder of Dioscorea opposite rhizome (with the ratio of 1:1:1:1) in presence of sufficient viscous solution of Pueraria thomsonii Benth used as anemic and chelating agent. Similar to the conventional treatment of diabetes mellitus, sets of blood glucose and splenic function tests were monthly conducted for checking the reduction of the concentration of blood glucose, if any. HbA1c test was performed by using Direct Enzymatic HbA1c Method
Intervention code [1] 288449 0
Treatment: Drugs
Intervention code [2] 288450 0
Treatment: Other
Comparator / control treatment
NA- This is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291086 0
The effect of ANIVINA on lowering blood glucose levels after taking the ANIVINA for 183 days as assessed by the HbA1c test. HbA1c test was performed by using Direct Enzymatic HbA1c Method applying Chromatography based HPLC assay.
Timepoint [1] 291086 0
Assessed on a monthly basis throughout the duration of the treatment, and at 6 months after end of treatment
Secondary outcome [1] 305985 0
The effect of ANIVINA on postprandial blood glucose levels

HbA1c test was performed by using Direct Enzymatic HbA1c Method
Timepoint [1] 305985 0
Assessed at 6 months when the intervention treatment has been completed

Eligibility
Key inclusion criteria
All participated patients aged between 52-85 years old, diagnosed with type 2 diabetes mellitus were informed about the purposes, methods and intended uses of the research. They were informed about what participation will involve and the risks as well as potential benefits explained. Moreover. the participants were allowed to withdraw themselves from participation at any time and for any reason without disadvantage and all information as well as data obtained about participants were confidential
Minimum age
52 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Out of age range of 52-85

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients were administered ANIVINA with a single dose of 1200 mg/kg daily for 93 days.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA- This is a single group study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/08/2012
Actual
21/08/2012
Date of last participant enrolment
Anticipated
21/11/2012
Actual
21/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
94
Accrual to date
Final
Recruitment outside Australia
Country [1] 5676 0
Viet Nam
State/province [1] 5676 0
Saigon

Funding & Sponsors
Funding source category [1] 288430 0
Self funded/Unfunded
Name [1] 288430 0
Country [1] 288430 0
Primary sponsor type
Individual
Name
Nguyen Van Toan
Address
School of Biotechnology, International University
Vietnam National University
Block 6, Linh Trung Ward, Thu Duc District, Ho Chi Minh City, Vietnam
Country
Viet Nam
Secondary sponsor category [1] 287133 0
None
Name [1] 287133 0
Address [1] 287133 0
Country [1] 287133 0
Other collaborator category [1] 277729 0
Individual
Name [1] 277729 0
Buddhist Priest Thich Giac Lam from Dat Nhau ward, Bu Dang District, Binh Phuoc Province, Vietnam
Address [1] 277729 0
Dat Nhau ward, Bu Dang District, Binh Phuoc Province, Vietnam
Country [1] 277729 0
Viet Nam

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290305 0
School of Biotechnology, International University, Ho Chi Minh City,Vietnam National University, Ho Chi Minh City, Vietnam
Ethics committee address [1] 290305 0
Ethics committee country [1] 290305 0
Viet Nam
Date submitted for ethics approval [1] 290305 0
16/02/2013
Approval date [1] 290305 0
Ethics approval number [1] 290305 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44966 0
Dr Nguyen Van Toan
Address 44966 0
School of Biotechnology, International University, Vietnam national university. Block VI, Linh Trung Ward, Thu Duc District, Ho Chi Minh City
Country 44966 0
Viet Nam
Phone 44966 0
+84 972304607
Fax 44966 0
Email 44966 0
[email protected]
Contact person for public queries
Name 44967 0
Nguyen Tan Phat
Address 44967 0
Huynh Thuc Khang, high school Van Gia, Van Ninh, Khanh Hoa
Country 44967 0
Viet Nam
Phone 44967 0
+84 58 3910368
Fax 44967 0
Email 44967 0
[email protected]
Contact person for scientific queries
Name 44968 0
Steven Neill
Address 44968 0
Associate Dean, Faculty of Health and Life Sciences (International and Head of School of Life Sciences) Director, Centre for Research in Plant Science University of the West of England, Bristol Bristol BS16 1QY
Country 44968 0
United Kingdom
Phone 44968 0
+44 (0) 117 32 86554
Fax 44968 0
+44 (0) 117 32 82132
Email 44968 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

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