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A Randomized Controlled Multicenter Clinical Study on the Prevention and Treatment of Hashimoto's Thyroiditis with Normal Thyroid Function by the Combination of Cereal Dietary Fiber

A Randomized Controlled Multicenter Clinical Study on the Prevention and Treatment of Hashimoto's Thyroiditis with Normal Thyroid Function by the Combination of Cereal Dietary Fiber

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067009
Enrollment
Unknown
Registered
2022-12-23
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hashimoto thyroiditis

Interventions

Dietary fiber group:Dietary fiber
Comprehensive treatment group:the Combination of Cereal Dietary Fiber and "Xiaoying Tie"
control group:Lifestyle intervention

Sponsors

Shanghai Jing'an Zhabei Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Those who meet the above diagnostic criteria and whose serum TGAb and TPOAb indicators are within the measurable range have clinical hyperthyroidism and hypothyroidism, and thyroid function is normal; 2. The patient is conscious and willing to participate in the study and sign the informed consent form; 3. Aged > 18 years.

Exclusion criteria

Exclusion criteria: 1. Patients with goiter and compression of adjacent organs or patients with thyroid heart disease; 2. Thyroid enlargement with exophthalmos, TGAb (+), slightly increased TPOAb titer and other thyroid diseases diagnosed; 3. People with serious heart, liver, kidney and other organ complications and blood system diseases; 4. Pregnant or lactating women; 5. Patients with allergic constitution or known hypersensitivity to food and drugs used in the test; 6. Those with poor compliance, withdrawal and incomplete data, but those with adverse reactions were counted; 7. Gastrointestinal ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa, or suspected malignant disease are complicated; 8. Patients with gastroesophageal reflux disease or irritable bowel syndrome; 9. In the past 3 months, the following diseases received medical treatment: cholecystitis,gastrointestinal ulcer, urinary tract infection, acute pyelonephritis, cystitis; 10. Have undergone gastrointestinal surgery, such as appendectomy.

Design outcomes

Primary

MeasureTime frame
Thyroglobulin antibody, TGAb;Diversity and composition of intestinal flora;Thyroid peroxidase antibody, TPOAb;

Secondary

MeasureTime frame
Alanine aminotransferase;Creatinine;routine blood test;Free triiodothyronine, FT3;Free thyroxine, FT4;Thyroid stimulating hormone;Cytokine TNF- a;Cytokine IL-10;Cytokine IL-6;Cytokine INF-y;regulatory T cell, Treg;

Countries

China

Contacts

Public ContactPan Jing, Zhang Meizhu

Shanghai Jing'an Zhabei Central Hospital; Shanghai Jing'an District Baoshan Road Neighborhood Community Health Service Center

Zmz18817943887zmz@163.com+86 18817943887

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026