Herbagut® for the Treatment of Digestive Complaints in Adults

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: 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. CONDITION: Gastrointestinal complaints; ; Gastrointestinal complaints Oral and Gastrointestinal ‐ Normal oral and gastrointestinal development and function PRIMARY OUTCOME: Gastrointestinal symptoms assessed by total score on Gastrointestinal Symptom Rating Scale (GSRS)[Weeks 0, 4 and 8 (primary timepoint)] Taxonomic change in Intestinal bacteria as assessed by stool sample and 16S rRNA gene sequencing[Days 0 and 60 (primary timepoint); ] SECONDARY OUTCOME: Abdominal pain assessed by Gastrointestinal Symptom Rating Scale (GSRS)[Weeks 0, 4 and 8 ; ] Change in serum concentrations of vitamin B12[Weeks 0 and 8 ; ] Change in serum concentrations of vitamin D[Weeks 0 and 8 ; ] General health assessed by Short‐Form‐36 (SF‐36)[Weeks 0, 4 and 8 ; ] Indigestion symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)[Weeks 0, 4 and 8] Pain assessed by Short‐Form‐36 (SF‐36) ; [Weeks 0, 4 and 8 ; ] Reflux symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)[Weeks 0, 4 and 8] 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
Epistemonikos ID: a5916d914330bd779eb8eea73aa0563da2cf17e5
First added on: Aug 24, 2024