None listed
Conditions
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.
Interventions
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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
Outcome results
None listed