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The Effect of oral consumption of Nigella Sativa in the treatment of autoimmune Hypothyroidism

compare the effect of Nigella Sativa powder in the supplement group and placebo on the Serum Levels of Thyroid Hormones, Beta Transforming Growth Factor, Interlukin 23, Lipid Pattern and markers of oxidative stress in Hashimoto’s Thyroiditis patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014090819082N2
Enrollment
40
Registered
2014-09-29
Start date
2014-09-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Hashimoto’s Thyroiditis. Autoimmune thyroiditis

Interventions

Intervention 1: Nigella sativa group will receive 2 gram of Nigella sativa powder in the form of 1 gram packs with lunch and dinner meals for 8 weeks.The supplement will be given weekly and during the
Treatment - Drugs
Placebo
Nigella sativa group will receive 2 gram of Nigella sativa powder in the form of 1 gram packs with lunch and dinner meals for 8 weeks.The supplement will be given weekly and during the consumption pos
Placebo group will receive 2 gram of starch in the form of 1-gram packs with lunch and dinner meals weekly for 8 weeks and during the consumption possible side effects and keeping on consumption will

Sponsors

Vice chancellor for Research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Age Range of 20-50; Suffering from Hashimoto disease with the Diagnosis of Physician based on specialized Tests; Completing Informed Consent Form. Exclusion Criteria: not signed informed consent Form; physiologic Special conditions such as pregnancy and breast-feeding; receiving supplements such as Vitamin E, C, Zinc, Folat, Cobalamin, Soy fitoestrogens in the last 3 month; suffering from any auotoimmune disease; history of thyroid operation, following any special diet

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum concentration ofIL-23. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.;Serum concentration ofTGF-ß. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.;Serum concentration ofT4, T3? TSH?TPOAb. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.;Serum concentration ofT4, T3? TSH?TPOAb. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.;Added at 2017-02-12: Serum Concentrations of MDA, GPX, SOD and TAC. Timepoint: Added at 2017-02-12: Before and after intervention. Method of measurement: Added at 2017-02-12: ELIZA.;Added at 2017-02-12: Serum TAC. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELIZA.;Added at 2017-02-12: Serum CAT. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELIZA.;Added at 2017-02-12: Serum GPX. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELIZA.;Added at 2017-02-12: Serum SOD. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELISA.

Secondary

MeasureTime frame
Physical Activity. Timepoint: At baseline and after 2 months of intervention. Method of measurement: Physical Activity Questionare.;Receiving Energy and Macronutrients. Timepoint: Before The first month termination and after the eight week. Method of measurement: 24-hour memorial questionare.;BMI. Timepoint: At baseline and after 2 months of intervention. Method of measurement: Weight divided by Height Square.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSirus Tajmiri

Tabriz University of Medical Sciences

+98 910 515 0752

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 7, 2026