Rubus Sanctus (Wild Blackberry) Root Extract as a Dietary Supplement for Graves' Disease

NCT07164079 | Recruiting

• 1 other identifier: 2024-40160-152
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this single-blind, randomized, experimental study was to investigate the effect of Rubus sanctus root extract, which has antioxidant properties, added to the routine diet of patients with Graves' disease on the prognosis of the disease. The study sample included patients who presented to the Endocrinology and Metabolic Diseases Outpatient Clinic of Muğla Sıtkı Koçman University Training and Research Hospital and were diagnosed with Graves' disease or developed a relapse after necessary examinations. Cohen's standardized effect size was used. Accordingly, the required sample size for the study was determined to be 42, using an alpha value of 0.05, an effect size of 0.80, and a theoretical power of 80%. The study planned to include a minimum of 42 participants: 21 intervention participants and 21 controls. Patients assigned to the control group were asked to continue their routine diet, adhere to any necessary pharmacological treatments, and consume a placebo tea for the planned 8-week intervention period. Routine monthly examinations will be collected, and anthropometric measurements will be repeated at the end of 8 weeks. Patients assigned to the experimental group will be asked to continue their routine diet for 8 weeks, comply with any required pharmacological treatments, and consume Rubus sanctus root extract, produced by aqueous extraction and lyophilization, with active ingredient (phenolic compound) determined by LC-MS-MS, and prepared as a tea in 5-g packets. Anthropometric measurements will be repeated at the end of 8 weeks. H0: Rubus sanctus root extract supplemented to the diet has no effect on Graves' disease. H1: Rubus sanctus root extract supplemented to the diet has an effect on Graves' disease.

Conditions

Graves Disease (Basedow's Disease)

Keywords

Rubus sanctus; Basedow disease; Toxic diffuse goiter; HEI

Outcome Measures

Primary Outcomes (3)

• Effect of Rubus sanctus root on thyroid hormones

  It will be determined whether the use of Rubus sanctus in Graves' patients causes changes in the blood parameters of the thyroid hormones TSH, T4, and T3 associated with the disease.

  8-week intervention

• Effect of Rubus sanctus use on disease-related autoimmune markers

  It will be determined whether the use of Rubus sanctus in Graves' disease patients causes changes in blood parameters such as anti-TPO, anti-TG, and TSH receptor antibodies, which are autoimmune markers associated with the disease.

  8-week intervention

• Determination of anatomical and structural changes in the thyroid gland due to the use of Rubus sanctus

  The effect of Rubus sanctus use on thyroid parenchymal echogenicity and thyroid volume in Graves' disease will be determined by thyroid ultrasound.

  8-week intervention

Study Arms (2)

Blackberry root group

EXPERIMENTAL

Patients in the intervention group will receive a Rubus Sanctus root extract, which they will consume with breakfast for 8 weeks.

Dietary Supplement: blackberry root

Black Tea group

PLACEBO COMPARATOR

Patients with Graves' disease assigned to the control group will be asked to consume black tea (Camellia sinensis) with their breakfast for 8 weeks.

Dietary Supplement: black tea

Interventions

blackberry root DIETARY_SUPPLEMENT

Patients in the intervention group will receive a Rubus Sanctus root extract, which they will consume with breakfast for 8 weeks. The tea will be packaged as 5 grams of Rubus Sanctus root and steeped in 200 ml of water at 80°C for 5 minutes. Participants in the intervention group will receive the Rubus Sanctus root tea along with the necessary equipment (a 200 ml beaker and thermometer). Measurements of TSH, T4, T3, anti-TPO, anti-TG, TSH receptor antibodies, liver function tests, thyroid parenchymal echogenicity, and thyroid volume will be taken at the Endocrinology and Metabolic Diseases Clinic of Muğla Training and Research Hospital before and after the study.

Blackberry root group

black tea DIETARY_SUPPLEMENT

Patients with Graves' disease assigned to the control group will be asked to consume black tea (Camellia sinensis) with their breakfast for 8 weeks. Black tea is a product consumed almost daily in Turkish society. Black tea will be prepared in 5-g doses and steeped in 200 ml of water at 80°C for 5 minutes. Participants in the control group will be provided with black tea bags along with the necessary equipment (a 200 ml beaker and thermometer). TSH, T4, T3, anti-TPO, anti-TG, TSH receptor antibody, liver function tests, thyroid parenchymal echogenicity, and thyroid volume will be obtained before and after the study at the Endocrinology and Metabolic Diseases Clinic of Muğla Training and Research Hospital.

Black Tea group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Having received treatment for the disease within the last 6 months
• Having another chronic and/or autoimmune disease
• Being pregnant or lactating

Sponsors & Collaborators

• Betul Uner: lead

Study Sites (1)

Muğla Sıtkı Koçman University/Muğla Training and Research Hospital Endocrine and Metabolic Diseases Polyclinic

Muğla, Mentese, 48000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Yang H, Bi X, Tang H, Zeng J, Cong Y, Wu T, Chen Q. Clinical efficacy of Yingliu treatment for Graves disease. Int J Clin Exp Med. 2015 Apr 15;8(4):6145-53. eCollection 2015.

  PMID: 26131218 BACKGROUND

• Jaradat N, Dwikat M, Amer J, Hawash M, Hussein F, Qneibi M, Issa L, Asab JA, Hallak H, Arar DN, Masri HZ, Obeid K, Sharabati M, Kittaneh R. Anticancer, Free Radicals, and Digestive Enzyme Inhibitory Activities of Rubus sanctus Schreb Root Four Solvent Fractions. Evid Based Complement Alternat Med. 2021 Jun 16;2021:6690646. doi: 10.1155/2021/6690646. eCollection 2021.

  PMID: 34221089 BACKGROUND

MeSH Terms

Conditions

Graves Disease

Interventions

Tea

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Betül Üner Yılmaz, Lecturer

  https://www.mu.edu.tr/tr/personel/betuluner

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Üner Yılmaz

CONTACT

+905077138298; betul.uner@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, MSc

Model Details: Patients with newly diagnosed or recurrent Graves' disease will receive an 8-week intervention. Graves' disease patients assigned to the control group will be asked to consume black tea (Camellia sinensis) with their breakfast for 8 weeks. The black tea will be prepared as 5 g doses and steeped in 200 ml of water at 80 °C for 5 minutes. The intervention group will be given Rubus Sanctus root extract, which they will consume with breakfast for 8 weeks. The tea will be packaged as 5 g Rubus Sanctus root and steeped in 200 ml of water at 80 °C for 5 minutes. Participants in the intervention and control groups will receive black tea and Rubus Sanctus root tea, along with the necessary equipment (a 200 ml beaker and a thermometer).

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 9, 2025
• Study Start: December 12, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: December 2024 - December 2026

Locations

TU (1)