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Trial registered on ANZCTR


Registration number
ACTRN12621000480886
Ethics application status
Approved
Date submitted
29/03/2021
Date registered
23/04/2021
Date last updated
15/08/2023
Date data sharing statement initially provided
23/04/2021
Date results provided
6/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of the herbal preparation, STW5-II on lower oesophageal sphincter function in healthy volunteers.
Scientific title
The effects of the herbal preparation, STW5-II on lower oesophageal sphincter function in healthy volunteers.
Secondary ID [1] 303482 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia 320800 0
Condition category
Condition code
Oral and Gastrointestinal 318622 318622 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects.

Two study visits, separated by at least four days, are required. Visits will last approximately 3 hours each. Participants will receive, in randomised, double-blind fashion, oral administration of either (i) 20 drops (1.1ml) of STW5-II or (ii) 20 drops (1.1ml) control solution (i.e. containing no active ingredients).
For both study visits, participants will fast for ~14 hrs overnight, and abstain from alcohol and vigorous exercise for 24 hrs prior to each visit. On each study day, participants will attend the Gut Function Laboratories at the Department of Surgery, Flinders Medical Centre.

Upon arrival, participants will be intubated with an 8 French (2.5mm diameter) solid-state unidirectional high-resolution manometry catheter (32 pressure sensors at 1cm, 16, 2 cm length impedance segments, Unisensor/Laborie, Attikon, Switzerland) which will be used to measure oesophago-gastric junction (OGJ) pressures. The catheter will be inserted through an anaesthetised nostril and passed until the pressure array straddles the OGJ region from distal oesophagus to stomach. Once correctly positioned and fixed in place, the sensor array straddling the OGJ, will not need further adjustment. After a 10-min period to accommodate to the presence of the catheter, baseline OGJ pressure will be recorded for a 10-min period (t = -15 to -5 min) during which time each participant will complete a VAS questionnaire to assess GI perceptions (fullness, nausea, bloating). These scales consist of a horizontal line, 100 mm long, on which the participant places a vertical mark across the line, indicating the strength of each symptom felt at that time, with 0 mm indicating that the symptom is not felt and 100 mm that the symptom is extremely strong. At t = -5 min, participants will ingest 50 ml of water with either (i) STW5-II or (ii) control solution (as stated previously), immediately followed by a mixed solid-liquid meal to be consumed within 5 min. The meal will consist of 100 g minced beef burger (270 kcal, 25 g protein, 21 g fat) and will be immediately followed by 150 ml of dextrose (10 %, 62 kcal). Complete ingestion of STW5-II or placebo, each with 50 mls water, and the meal, will be confirmed by the investigator. OGJ pressures will then be measured for 120 min, and participants will complete VAS questionnaires every 15 min. At t = 120 min, the manometric assembly will be removed. The participant will be offered a light refreshment after which they will be free to leave the laboratory.
Intervention code [1] 319770 0
Treatment: Other
Comparator / control treatment
20 drops (1.1 ml) Ethanolic liquid
Control group
Placebo

Outcomes
Primary outcome [1] 326579 0
Mean pressure (mmHg) and pressure integral (mmHg x length of high pressure zone) at the oesophago-gastric junction. This is a composite outcome.
Timepoint [1] 326579 0
Pressure and impedance data will be acquired at 20Hz. For each study visit, mean pressure and presure integral will be measured per 15 min segment of OGJ measurement between t = 0 min and t = 120 min.
Secondary outcome [1] 391956 0
Appetite sensations (hunger, fullness, thirst, desire to eat, amount of food the subject thinks they could eat) and gastrointestinal symptoms (nausea, bloating). This is a composite outcome.
Timepoint [1] 391956 0
Measurements will use a 100mm Visual Analogue Scale (VAS). For each study visit, VAS measurements will be taken before the meal (baseline) and at 15 min intervals between t = 0 and 120 min.

Eligibility
Key inclusion criteria
Healthy, lean (BMI: 19-25 kg/m2) male and female volunteers will be included. Participants will be required to be weight-stable (ie <5% fluctuation) at study entry. Females will be required to be premenopausal and studied during the follicular phase of the menstrual cycle.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each participant will be questioned prior to the study to exclude:
- regular GI symptoms, as measured by the GI symptom score (score >1 for any component), or significant GI disease or surgery
- use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
- regular medication that cannot be discontinued during the study
- lactose intolerance/other food allergy, or allergy to any of the ingredients of STW5-II
- current gallbladder or pancreatic disease
- cardiovascular or respiratory diseases
- epilepsy
- any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
- high performance athletes
- current intake of > 2 standard drinks on > 5 days per week
- current smokers/users of tobacco products (including pipe, chewing, cigarettes, cigars, sheesha, vaping)
- recreational drug use (e.g marijuana)
- current intake of any illicit substance
- vegetarians
- inability to tolerate oro/naso-gastric tube
- inability to comprehend study protocol
- in female participants, pregnancy, lactation or surgical sterilisation (a pregnancy test will be performed, using a urine sample, prior to each study day)

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
21/07/2021
Date of last participant enrolment
Anticipated
Actual
16/03/2022
Date of last data collection
Anticipated
Actual
23/03/2022
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307899 0
Commercial sector/Industry
Name [1] 307899 0
Steigerwald Arzneimittelwerk GmbH
Country [1] 307899 0
Germany
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace,
Adelaide 5005,
South Australia
Country
Australia
Secondary sponsor category [1] 308612 0
Individual
Name [1] 308612 0
Professor Christine Feinle-Bisset
Address [1] 308612 0
Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George Street,
Adelaide 5005,
South Australia
Country [1] 308612 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307897 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307897 0
Ethics committee country [1] 307897 0
Australia
Date submitted for ethics approval [1] 307897 0
Approval date [1] 307897 0
31/08/2020
Ethics approval number [1] 307897 0

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

Contacts
Principal investigator
Name 108862 0
Prof Christine Feinle-Bisset
Address 108862 0
University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005
South Australia
Country 108862 0
Australia
Phone 108862 0
+61 8 8313 6053
Fax 108862 0
Email 108862 0
christine.feinle@adelaide.edu.au
Contact person for public queries
Name 108863 0
Christine Feinle-Bisset
Address 108863 0
University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005
South Australia
Country 108863 0
Australia
Phone 108863 0
+61 8 8313 6053
Fax 108863 0
Email 108863 0
christine.feinle@adelaide.edu.au
Contact person for scientific queries
Name 108864 0
Christine Feinle-Bisset
Address 108864 0
University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005
South Australia
Country 108864 0
Australia
Phone 108864 0
+61 8 8313 6053
Fax 108864 0
Email 108864 0
christine.feinle@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In line with IP Agreement


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.