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Trial registered on ANZCTR


Registration number
ACTRN12619001514190
Ethics application status
Approved
Date submitted
29/10/2019
Date registered
1/11/2019
Date last updated
21/11/2019
Date data sharing statement initially provided
1/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Herbagut® for the Treatment of Digestive Complaints in Adults
Scientific title
Effects of Herbagut® in adults with self-reported digestive complaints: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 299667 0
None
Universal Trial Number (UTN)
U1111-1242-7186
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal complaints 315006 0
Condition category
Condition code
Oral and Gastrointestinal 313346 313346 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two capsules containing a proprietary herbal blend (Herbagut®) will be consumed once daily for 8 weeks by adults aged between 18 and 70 years. Adherence to capsule intake will be monitored through capsule return and count.
Intervention code [1] 315929 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing microcellulose) is matched to the Herbagut® capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 321821 0
Gastrointestinal symptoms assessed by total score on Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [1] 321821 0
Weeks 0, 4 and 8 (primary timepoint)
Primary outcome [2] 321822 0
Taxonomic change in Intestinal bacteria as assessed by stool sample and 16S rRNA gene sequencing
Timepoint [2] 321822 0
Days 0 and 60 (primary timepoint)
Secondary outcome [1] 376348 0
Change in serum concentrations of vitamin D
Timepoint [1] 376348 0
Weeks 0 and 8
Secondary outcome [2] 376349 0
Change in serum concentrations of vitamin B12
Timepoint [2] 376349 0
Weeks 0 and 8
Secondary outcome [3] 376350 0
General health assessed by Short-Form-36 (SF-36)
Timepoint [3] 376350 0
Weeks 0, 4 and 8
Secondary outcome [4] 376351 0
Pain assessed by Short-Form-36 (SF-36)
Timepoint [4] 376351 0
Weeks 0, 4 and 8
Secondary outcome [5] 376374 0
Abdominal pain assessed by Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [5] 376374 0
Weeks 0, 4 and 8
Secondary outcome [6] 376375 0
Reflux symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [6] 376375 0
Weeks 0, 4 and 8
Secondary outcome [7] 376376 0
Indigestion symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [7] 376376 0
Weeks 0, 4 and 8

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) between 18 and 70
2. Mild-to-moderate severity gastrointestinal complaints as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (total score between 10 and 29)
3. Medication-free for at least 3 months. Use of analgesics (once a week) or contraceptive pills are permissible.
4. Non-smoker
5. BMI between 25 and 35
6. No plan to change diet or commence new treatments over study period
7. Willing to complete an online informed consent form detailing all pertinent aspects of the trial
8. Willing and able to take prescribed Herbagut/placebo capsules for 8 weeks
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Alcohol consumption > 14 standard drinks per week
2. Current or 12-month history of illicit drug abuse
3. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
4. Diagnosis of a medical, psychiatric or neurological condition/ disease including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
5. Diagnosis of gastrointestinal disease including but not limited to: inflammatory bowel disease, diverticular disease, ulcerative colitis, coeliac disease, gastritis, gastro-oesophageal reflux disease, or irritable bowel syndrome
6. Current use of supplements that may affect digestive function, unless been on stable dose over last 60 days before baseline assessment
7. Currently taking prebiotic or probiotic supplements, unless been on stable dose over last 60 days before baseline assessment
8. Hypersensitive to herbs or spices

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated into placebo and treatment groups. These groups are named group 1 and group 2 and the primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 50) based on the order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 50 into either group 1 or 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on a previous study on Herbagut, we are predicting an effect size of 0.8. Based on this, a total sample size of 42 is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 50 participants, which should give us a suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:
1. Gastrointestinal Symptom Rating Scale (GSRS) (total and subscale scores reflux, abdominal pain, indigestion, diarrhoea, and constipation)
2. Intestinal microbial diversity and bacterial compositions
3. Change in serum concentrations of vitamin D
4. Change in serum concentrations of vitamin B12
5. Short Form-36 (SF-36) subscale scores

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304143 0
Commercial sector/Industry
Name [1] 304143 0
Arjuna Natural Private Limited
Address [1] 304143 0
Bank Rd, Periyar Nagar, Aluva, Kerala 683101, India
Country [1] 304143 0
India
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 304373 0
None
Name [1] 304373 0
Address [1] 304373 0
Country [1] 304373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304623 0
National Institute of Integrative Medicine (NIIM)
Ethics committee address [1] 304623 0
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 304623 0
Australia
Date submitted for ethics approval [1] 304623 0
30/08/2019
Approval date [1] 304623 0
04/10/2019
Ethics approval number [1] 304623 0
0053E_2019

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 50 adults who are currently experiencing digestive complaints will be randomly assigned to receive capsules containing either a herbal combination or placebo for 8 weeks. We will assess change in digestive symptoms, intestinal bacteria, vitamin D and B12 concentrations, and overall quality of life.
Trial website
https://clinicalresearch.com.au/cra-studies/herbagut-study/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97626 0
Dr Adrian Lopresti
Address 97626 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 97626 0
Australia
Phone 97626 0
+61894487376
Fax 97626 0
+61894478217
Email 97626 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 97627 0
Dr Adrian Lopresti
Address 97627 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 97627 0
Australia
Phone 97627 0
+61894487376
Fax 97627 0
+61894478217
Email 97627 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 97628 0
Dr Adrian Lopresti
Address 97628 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 97628 0
Australia
Phone 97628 0
+61894487376
Fax 97628 0
+61894478217
Email 97628 0
adrian@clinicalresearch.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by principal investigator by emailing the principal investigator adrian@clinicalresearch.com.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results