Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000204842
Ethics application status
Approved
Date submitted
10/12/2020
Date registered
26/02/2021
Date last updated
15/08/2023
Date data sharing statement initially provided
26/02/2021
Date results provided
8/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of the herbal preparation, STW5-II, on gastric emptying in healthy volunteers.
Scientific title
The effects of the herbal preparation, STW5-II, on gastric emptying and intragastric distribution in healthy volunteers.
Secondary ID [1] 302933 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia 319958 0
Condition category
Condition code
Oral and Gastrointestinal 317893 317893 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, compared with placebo, 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, each lasting approximately 3 hours. 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 Gamma Camera Suite at the Clinical Research Facility, Adelaide Medical School, Adelaide Health and Medical Sciences (AHMS) Building at 8:30am.
Upon arrival, the participant will rest quietly, seated with their back against a gamma camera. The participant will then be asked to complete a visual analogue scale (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. Further VAS questionnaires will be administered at 15-min intervals throughout the study. The participant will then ingest 50 ml of water with either (i) STW5-II or (ii) control solution (as stated previously), immediately followed by a solid-liquid meal to be consumed within 5 min. Complete ingestion of STW5-II or placebo, each with 50 mls water, will be confirmed by the investigator. The meal will consist of 100 g minced beef burger (270 kcal, 25 g protein, 21 g fat) radiolabelled with 20 MBq 99mTc-sulphur colloid and will be immediately followed by 150 ml of dextrose (10 %, 62 kcal) radiolabelled with 7 MBq 67Ga-EDTA. Gastric emptying and intragastric meal distribution of the solid and liquid components of this meal will be measured from t = 0-120 min, where t = 0 min represents the time of meal completion. On one of the study days (decided by the investigator), following the 120 min intervention, participants will drink 100 ml water containing 4 MBq of 99mTc-sulphur colloid, and a lateral image of the stomach will be acquired to derive correction factors for gamma ray attenuation. This will take < 5 min.
At the end of the study day, the participant will be offered a light lunch and then be free to leave the laboratory.
Intervention code [1] 319606 0
Treatment: Other
Comparator / control treatment
20 drops (1.1 ml) Ethanolic liquid
Control group
Placebo

Outcomes
Primary outcome [1] 325946 0
Gastric emptying of the meal, as assessed by 50% emptying time (T50%) for the liquid component and retention of the solid component at 100 min (T100min). This is a composite outcome.
Timepoint [1] 325946 0
Gastric emptying curves will be used to derive 50% emptying time (T50%) occurring between 0 and 180 min and the solid retention at 100 min..
Secondary outcome [1] 389781 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] 389781 0
Measurements will use a 100mm Visual Analogue Scale (VAS). VAS measurements will be taken before the meal (baseline) and at 15 min intervals between t = 0 and 180 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
40 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 where it may affect outcomes
- 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)
- Exposure to ionising radiation from X-ray machines or radioactive substances in the last 12 months for research purposes
- 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 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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
The study was stopped early due to recruitment not having advanced adequately before the herbal preparation becoming out of date
Date of first participant enrolment
Anticipated
1/03/2021
Actual
8/07/2021
Date of last participant enrolment
Anticipated
Actual
2/06/2022
Date of last data collection
Anticipated
Actual
29/06/2022
Sample size
Target
16
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307354 0
Commercial sector/Industry
Name [1] 307354 0
Steigerwald Arzneimittelwerk GmbH
Country [1] 307354 0
Germany
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace,
Adelaide 5005,
South Australia
Country
Australia
Secondary sponsor category [1] 307995 0
Individual
Name [1] 307995 0
Professor Christine Feinle-Bisset
Address [1] 307995 0
Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George Street,
Adelaide 5005,
South Australia
Country [1] 307995 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307440 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307440 0
Ethics committee country [1] 307440 0
Australia
Date submitted for ethics approval [1] 307440 0
Approval date [1] 307440 0
31/08/2020
Ethics approval number [1] 307440 0

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

Contacts
Principal investigator
Name 107246 0
Prof Christine Feinle-Bisset
Address 107246 0
University of Adelaide,
Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005,
South Australia
Country 107246 0
Australia
Phone 107246 0
+61 8 8313 6053
Fax 107246 0
Email 107246 0
[email protected]
Contact person for public queries
Name 107247 0
Christine Feinle-Bisset
Address 107247 0
University of Adelaide,
Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005,
South Australia
Country 107247 0
Australia
Phone 107247 0
+61 8 8313 6053
Fax 107247 0
Email 107247 0
[email protected]
Contact person for scientific queries
Name 107248 0
Christine Feinle-Bisset
Address 107248 0
University of Adelaide,
Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005,
South Australia
Country 107248 0
Australia
Phone 107248 0
+61 8 8313 6053
Fax 107248 0
Email 107248 0
[email protected]

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.