Wild blackberry (Rubus sanctus) root extract added to the diet for Graves' disease
Effect of Dietary Supplementation of Rubus Sanctus (Wild Blackberry) Root Extract on Disease Prognosis in Graves' Disease: A Randomized Controlled Clinical Trial
This test sees if taking wild blackberry (Rubus sanctus) root extract as a daily supplement helps adults (18–65) with new or relapsing Graves' disease when added to their usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Muğla Sıtkı Koçman University Academic / other |
| Locations | 1 site (Muğla, Mentese) |
| Trial ID | NCT07164079 on ClinicalTrials.gov |
What this trial studies
This single-blind, randomized experiment added Rubus sanctus root extract as a dietary supplement to the routine care of adults with new or relapsing Graves' disease and compared outcomes to a placebo tea group. Participants were recruited at a university endocrine clinic in Muğla, Turkey, and the trial planned 42 people (21 per arm) based on an effect size of 0.80 and 80% power. Eligible participants were 18–65 years old with a Health Eating Index (HEI) score of 80 or higher and no other chronic or autoimmune diseases. The control group continued usual care and received a placebo tea while the intervention group received blackberry root extract added to the diet; outcomes focused on disease prognosis and related measures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 with a new diagnosis or relapse of Graves' disease, a HEI score ≥80, not pregnant or breastfeeding, and who have not received treatment for Graves' in the past six months.
Not a fit: Patients who recently received treatment for Graves' disease, have other chronic or autoimmune conditions, are pregnant or lactating, or who do not meet the HEI requirement are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding Rubus sanctus root extract could provide a low-cost, dietary antioxidant that improves disease course or symptom control in some people with Graves' disease.
How similar studies have performed: Some laboratory and traditional-use reports suggest antioxidant or anti-inflammatory effects of blackberry extracts, but clinical evidence specifically for Graves' disease is limited and this approach is largely novel in this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a new diagnosis of Graves' disease or those with a relapse of Graves' disease * Patients aged 18-65 * A score of 80 or higher on the Health Eating Index (HEI) Exclusion Criteria: * Having received treatment for the disease within the last 6 months * Having another chronic and/or autoimmune disease * Being pregnant or lactating
Where this trial is running
Muğla, Mentese
- Muğla Sıtkı Koçman University/Muğla Training and Research Hospital Endocrine and Metabolic Diseases Polyclinic — Muğla, Mentese, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Betül Üner Yılmaz, Lecturer — https://www.mu.edu.tr/tr/personel/betuluner
- Study coordinator: Betül Üner Yılmaz
- Email: betul.uner@gmail.com
- Phone: +905077138298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.