None listed
Conditions
Brief summary
The aim of this open-label, randomised, dose-comparison, pilot feasibility trial with two parallel arms is to determine the feasibility of using low and moderate doses of Curcutex (Meriva® Curcumin Phytosome®) for the management of EoE in adults. Primary Objective Evaluate the feasibility of using low and moderate doses of Curcutex (Meriva® Curcumin Phytosome®) for EoE in adults. Secondary Objectives 1. Ascertain whether Curcutex (Meriva® Curcumin Phytosome®) is safe in adults with EoE at low and moderate doses. 2. Assess whether Curcutex (Meriva® Curcumin Phytosome®) improves EoE-related symptoms in adults with EoE in low versus moderate doses. 3. Determine whether Curcutex (Meriva® Curcumin Phytosome®) improves Quality of Life in adults with EoE in low versus moderate doses. 4. Ascertain whether Curcutex (Meriva® Curcumin Phytosome®) reduces absolute eosinophil count in adults with EoE in low versus moderate doses. Current evidence suggests that orally administered Meriva®, at a dose of 500-1000 mg twice daily (or 1-2 g per day) for 12 weeks is safe and effective at reducing inflammation and pain in chronic inflammatory diseases such as EoE.
Interventions
1 capsule of Curcutex (Meriva® Curcumin Phytosome® 500 mg per capsule) twice daily (500 mg per dose, orally with breakfast and dinner) for 12 weeks. Participants will be advised to send a photo of the remaining investigational product at each follow up appointment (week 4, 8 and 12) so that the number of remaining capsules can be counted and confirmed by the researcher. Participants will be instructed to take any products remaining at study completion to their local pharmacy for disposal. Interv
1 capsule of Curcutex (Meriva® Curcumin Phytosome® 500 mg per capsule) twice daily (500 mg per dose, orally with breakfast and dinner) for 12 weeks. Participants will be advised to send a photo of the remaining investigational product at each follow up appointment (week 4, 8 and 12) so that the number of remaining capsules can be counted and confirmed by the researcher. Participants will be instructed to take any products remaining at study completion to their local pharmacy for disposal. Intervention use also will be recorded in a self-reported daily participant diary.
Sponsors
Southern Cross University, National Centre for Naturopathic Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years and over. 2. Living in any state or territory of Australia. 3. Received a diagnosis of EoE confirmed by endoscopy and biopsy.
Exclusion criteria
1. Other oesophageal disorders unrelated to EoE. 2. Non-EoE related dysphagia. 3. Pregnant or breast-feeding women. 4. Does not speak or understand English to make an informed decision to join the trial. 5. Any liver enzyme greater than or equal to 2.0-fold the upper limit of normal (ULN). 6. History of, or currently experiencing liver damage/injury/problems as deemed clinically significant. 7. History of a blood clotting disorder or currently taking anti-coagulant medication (e.g., Warfarin, Dabigatran etc). 8. Acute disease (i.e., a rapid-onset disease or disorder that lasts a short time, and is accompanied by distinct, often intense symptoms). 9. Undergoing current chemotherapy, radiation, or other acute treatment for a major disease. 10. Unmanaged chronic disease not associated with EoE. 11.. Received any vaccination(s) less than 14 days prior to the enrolment visit, or have experienced any severe side effect/s after the vaccination. 12. Known allergy to the intervention (turmeric), or its excipients (sunflower, leucine, colloidal anhydrous silica, hypromellose, lecithin, microcrystalline cellulose, or silicified microcrystalline cellulose).
Outcome results
None listed