Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000766819
Ethics application status
Not yet submitted
Date submitted
3/11/2011
Date registered
19/07/2012
Date last updated
12/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improved treatment of Asthma by using natural sources of antioxidants
Scientific title
Novel drug composition for the treatment of Human Asthma
Secondary ID [1] 273318 0
'Nil"
Universal Trial Number (UTN)
U1111-1125-6317
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 279093 0
Chronic obstructive pulmonary disease (COPD) 279094 0
Condition category
Condition code
Respiratory 279281 279281 0 0
Chronic obstructive pulmonary disease
Respiratory 279282 279282 0 0
Asthma
Alternative and Complementary Medicine 279387 279387 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Asthma is a clinical syndrome that highly possible involves both airways inflammation with an oxidant/antioxidant imbalance, providing that reactive oxygen species (ROS) can lead to lung injury as a result of direct oxidative damage to epithelial cells and cells shedding, therefore the effectiveness of supplying regularly natural antioxidants has thoroughly been studied in management and or treatment of asthma. In this study, a kind of 500mg pill was prepared and named as BRONAS, and described as below:

- BRONAS was prepared from 200mg of dried extract powder of Hippocampus kuda, 200 mg of dried extract powder of Rhizoma Homalomenae 130 mg of honey, and then used hands to roll pills of around 500 mg each.

BRONAS is a combination bioactive antioxidant compounds that exhibits antioxidant activity in linoleic acid system, effective reducing power, DPPH radical scavenging, hydroxyl radical scavenging, superoxide radical scavenging, alkyl radical scavenging and inhibitory intracellular ROS (originated from the extract of Hippocampus kuda) together with presence of phenolics such as protocatechuic acid, vanillic acid, syringic acid, caffeic acid, p-coumaric acid, ferulic acid and apigenin (originated from the extract of Rhizoma Homalomena). Phenolic acids are the main phenols consumed by humans. These mentioned six phenolics are all prominent and naturally occurring, and all of them individually possess potent antioxidant activity(Rebecca J. Robbins, 2003; Natella, Nardini, Felice and Scaccini, 1999). The honey was intentionally used with the dried extract powder of Rhizoma Homalomenae and the extract powder of Hippocampus kuda since it has been scientifically considered as an antimicrobial agent and chelating in traditional medicine. In addition, there is a great variety of minor components, including phenolic acids and flavonoids, the enzymes glucose oxidase and catalase, ascorbic acid, carotenoids, organic acids, amino acids, proteins, and a-tocopherol (Kesic, Mazolovic, Crnkic, Catovic, Hadzidedic and Dragosevic, 2009).

Fifty two patients with asthma aged 12 – 65 years (24 Male :28 Female, forced expiratory volume in 1 s <60% predicted, Peek Expiratory Flow Rate (PEFR) <5%, Maximal Mid-expiratory Flow Rate (MMEFR)< 55%, and FEV1 to FVC <70%) taking BRONAS with a single dose of 1200 mg/kg daily for 49 days (BRONAS is a combined composition of natural antioxidants such as DPPH radical scavenging, hydroxyl radical scavenging, superoxide radical scavenging, alkyl radical scavenging and inhibitory intracellular ROS, phenolic acids and flavonoids of which, are commonly found in seahorse of Hippocampus kuda species; in medicinal plant of Rhizoma Homalomena species, and in honey). BRONAS was in the form of pill which was prepared from dried extract powder of Hippocampus kuda and dried extract powder of Hippocampus kuda (with a ratio of 1: 1 w/w) in presence of sufficient honey used as an antimicrobial and chelating agent. Similar to the classical treatment of asthma, sets of pulmonary functions test were monthly conducted for checking the reduction of asthmatic incidence, if any.
Intervention code [1] 283669 0
Treatment: Drugs
Intervention code [2] 283740 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279901 0
All the asthmatic patients were fully or almost fully recovered after taking the BRONAS for 83 days.

Pulmonary functions test was performed by Spirometry test, adapting the method of Ahmed S. Sahib et al (Faruk, Al-Jawad, Hayder, Al-Atabee, Ahmed S. Sahib, 2010) for checking possible effects of given medicines on the treated patients. By doing this, a total computerized spirometer (Discom-14 Autospiror, Chest Corporation Tokyo, Japan) that measure Forced Volume Capacity (FVC), Forced Expiratory Volume in First Second (FEV1), Peek Expiratory Flow Rate (PEFR), and Maximal Mid-expiratory Flow Rate (MMEFR) were extensively applied as it would provide predicted values.
Timepoint [1] 279901 0
The frequency of the measurements was monthly measured from for the treatment duration, and then 06 months after the end of treatment.
Secondary outcome [1] 294724 0
The ratio of FEV1 to FVC reached almost 94%.
Timepoint [1] 294724 0
16/02/2012 was the date at the end of the treatment.

Eligibility
Key inclusion criteria
Treatments that might lessen the recurrent attacks of breathlessness and wheezing to make it more susceptible to providing relief for asthmatic patients.

- Participants were informed about the purposes, methods and intended uses of the research. They were informed about what participation will involve and the risks and potential benefits explained.

- Participants wereallowed to withdraw themselves from participation at any time and for any reason without disadvantage.

- Information and data obtained about participants were confidential
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Out of age range of 12 to 65

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 BRONAS with a single dose of 1200 mg/kg daily for 21 days.

All the patients were advised to take the given medicine for 21 consecutive days and then stop for pulmonary function test.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Restricted randomization was used to generate the sequence in which subjects will be randomized and to control the randomization to achieve balance between groups in size or characteristics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 3940 0
Viet Nam
State/province [1] 3940 0
Saigon

Funding & Sponsors
Funding source category [1] 285648 0
Self funded/Unfunded
Name [1] 285648 0
none
Country [1] 285648 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] 269111 0
None
Name [1] 269111 0
Address [1] 269111 0
Country [1] 269111 0
Other collaborator category [1] 260332 0
Individual
Name [1] 260332 0
Buddhist Priest Thich Giac Lam from Dat Nhau ward, Bu Dang District, Binh Phuoc Province, Vietnam
Address [1] 260332 0
Dat Nhau ward, Bu Dang District, Binh Phuoc Province, Vietnam
Country [1] 260332 0
Viet Nam

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 272111 0
School of Biotechnology, International University, Ho Chi Minh City, Vietnam Vietnam National University, Ho Chi Minh City, Vietnam
Ethics committee address [1] 272111 0
Ethics committee country [1] 272111 0
Viet Nam
Date submitted for ethics approval [1] 272111 0
10/09/2011
Approval date [1] 272111 0
Ethics approval number [1] 272111 0

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

Contacts
Principal investigator
Name 33348 0
Dr Nguyen Van Toan
Address 33348 0
School of Biotechnology, International University, Vietnam national university.

Block VI, Linh Trung Ward, Thu Duc District, Ho Chi Minh City
Country 33348 0
Viet Nam
Phone 33348 0
+84 972304607
Fax 33348 0
Email 33348 0
[email protected]
Contact person for public queries
Name 16595 0
Nguyen Tan Phat
Address 16595 0
Huynh Thuc Khang, high school
Van Gia, Van Ninh, Khanh HOa
Country 16595 0
Viet Nam
Phone 16595 0
+84 58 3910368
Fax 16595 0
Email 16595 0
[email protected]
Contact person for scientific queries
Name 7523 0
Professor Steven Neill
Address 7523 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 7523 0
United Kingdom
Phone 7523 0
+44 (0) 117 32 86554
Fax 7523 0
+44 (0) 117 32 82132
Email 7523 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
SourceTitleYear of PublicationDOI
Dimensions AIRETRACTED ARTICLE: Improved treatment of Asthma by using natural sources of antioxidants2013https://doi.org/10.1186/2193-1801-2-278
N.B. These documents automatically identified may not have been verified by the study sponsor.