Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000186358
Ethics application status
Approved
Date submitted
1/02/2017
Date registered
3/02/2017
Date last updated
8/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation into the immunomodulating effects of Andrographis paniculata in healthy males
Scientific title
Immunological Effects of Andrographis paniculata in healthy adult males
Secondary ID [1] 291044 0
TGA Clinical Trials Notification - CT-2016-CTN-03380-1
Universal Trial Number (UTN)
U1111-1192-3206
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune function in healthy population 301836 0
Condition category
Condition code
Inflammatory and Immune System 301512 301512 0 0
Normal development and function of the immune system
Alternative and Complementary Medicine 301526 301526 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tablets containing 214.3 mg Andrographis paniculata extract. Standardised extract of Andrographis paniculata (leaf) 14:1 containing 75 mg andrographolide.
2 tablets taken daily (equivalent to 6.0 g dried leaf per day) for 14 days. Compliance will be assessed by monitoring of tablet return count.
Intervention code [1] 297040 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300920 0
Effect of supplementation of Andrographis paniculata on inflammatory cytokines, measured by immunoassay.
Timepoint [1] 300920 0
Baseline (prior to supplementation) and after 14 days of supplementation
Primary outcome [2] 300931 0
Effect of supplementation of Andrographis paniculata on heat shock proteins, measured by flow cytometry.
Timepoint [2] 300931 0
Baseline (prior to supplementation) and after 14 days of supplementation
Primary outcome [3] 300932 0
Effect of supplementation of Andrographis paniculata on cortisol, measured by immunoassay.
Timepoint [3] 300932 0
Baseline (prior to supplementation) and after 14 days of supplementation
Secondary outcome [1] 331187 0
Effect of supplementation of Andrographis paniculata on mood and psychological variables, assessed using the 'Perceived Stress Questionnaire'.
Timepoint [1] 331187 0
Baseline (prior to supplementation) and after 14 days of supplementation
Secondary outcome [2] 331229 0
Effect of supplementation of Andrographis paniculata on the 'Connor-Davidson Resilience Scale'
Timepoint [2] 331229 0
Baseline (prior to supplementation) and after 14 days of supplementation
Secondary outcome [3] 331230 0
Effect of supplementation of Andrographis paniculata on the 'Zung Self-rating Anxiety and Depression Scales'
Timepoint [3] 331230 0
Baseline (prior to supplementation) and after 14 days of supplementation

Eligibility
Key inclusion criteria
Healthy males 18-70 years old. Non-smokers.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current use of vitamin or herbal supplements. currently taking anti-hypertensive drugs, anti-coagulants, anti-platelet drugs, or immunosuppressants, Current infections, or antibiotic use in the past 4 weeks. History of anaphylaxis or allergic reaction to plants of the Acanthaceae family.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/02/2017
Actual
6/04/2017
Date of last participant enrolment
Anticipated
31/05/2017
Actual
1/08/2017
Date of last data collection
Anticipated
16/06/2017
Actual
24/08/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295475 0
Commercial sector/Industry
Name [1] 295475 0
Integria Healthcare (Australia) Pty Ltd.
Country [1] 295475 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integria Healthcare (Australia) Pty Ltd.
Address
Head Office Building 5, Freeway Office Park, 2728 Logan Road (PO Box 4854) Eight Mile Plains, QLD 4113
Country
Australia
Secondary sponsor category [1] 294301 0
None
Name [1] 294301 0
Address [1] 294301 0
Country [1] 294301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296807 0
University of New England Human Research Ethics Committee (EC00143)
Ethics committee address [1] 296807 0
Ethics Office
Research Development & Integrity
Research Division
Armidale NSW 2351
Ethics committee country [1] 296807 0
Australia
Date submitted for ethics approval [1] 296807 0
Approval date [1] 296807 0
01/09/2016
Ethics approval number [1] 296807 0
HE16-196

Summary
Brief summary
A wide range of animal and in vitro studies have demonstrated that the herbal medicine Andrographis paniculata (AP) possesses immunomodulatory, anti-inflammatory, antioxidant and anti-depressant properties.
This pilot trial examining the effects of Andrographis paniculata (AP) will be carried out by researchers from the University of New England (primary investigator - Dr Linda Agnew). They have previously reported that AP induces an immune response via altered stress protein levels in ex vivo studies. A number of other human clinical trials have confirmed that supplementation with AP reduces the severity of symptoms in upper respiratory tract infections. More information is needed however, before a definitive statement can be made regardings its mode of action and efficacy as a herbal medicine. The aims of this small-scale intervention study are to examine the effects of supplementation with AP on parameters of the immune, inflammatory, stress and antioxidant responses. These aims will be achieved by measuring immune, inflammatory and antioxidant markers in blood and saliva samples as well as psychological variables collected from healthy male volunteers taking AP for two weeks at a total daily dose equivalent to 6.0 g dried leaf equivalent. All measures will be taken at commencement of the trial, prior to intervention, and after 14 days of supplementation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72106 0
Dr Linda Agnew
Address 72106 0
School of Science and Technology
University of New England
Armidale NSW 2351
Country 72106 0
Australia
Phone 72106 0
+61 2 6773 2631
Fax 72106 0
+61 2 6773 3267
Email 72106 0
[email protected]
Contact person for public queries
Name 72107 0
Linda Agnew
Address 72107 0
School of Science and Technology
University of New England
Armidale NSW 2351
Country 72107 0
Australia
Phone 72107 0
+61 2 6773 2631
Fax 72107 0
+61 2 6773 3267
Email 72107 0
[email protected]
Contact person for scientific queries
Name 72108 0
Linda Agnew
Address 72108 0
School of Science and Technology
University of New England
Armidale NSW 2351
Country 72108 0
Australia
Phone 72108 0
+61 2 6773 2631
Fax 72108 0
+61 2 6773 3267
Email 72108 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.