Parkinson's disease. Parkinson's disease
Conditions
Interventions
Intervention 1: Intervention group: For 12 weeks, daily intake of one tablet containing 100 mg of first-class Sargol saffron prepared by Mojtahedi Company (preparation of tablets will be done at th
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: Agreement for participation in the study Age of 45 years old or more Diagnosis of Parkinson's disease based on United Kingdom PD Society Brain Bank (UKPDSBB) criteria Having the Hoehn and Yahr score less than 5 BMI equal or less than 40
Exclusion criteria
Exclusion criteria: Adherence to a specific diet or consumption of saffron supplement in the last 3 months Patients with other neurodegenerative diseases such as Huntington's disease, Wilson's disease Central nervous system infections such as meningitis Having a Hoehn and Yahr score of 5 out of 5 Patients with a history of saffron allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage of disease. Timepoint: At baseline and after 12 weeks. Method of measurement: Hoehn and Yahr scale.;Serum level of C-reactive protein (CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Biorex Fars kit.;Symptoms of Parkinson's disease (motor and non-motor). Timepoint: At baseline and after 12 weeks. Method of measurement: Using the MDS-UPDRS questionnaire.;Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.;Activity of Catalase enzyme. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.;Malondialdehyde (MDA) serum level. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.;Glutathione serum level. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.;Zonulin serum level. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life. Timepoint: At baseline and after 12 weeks. Method of measurement: Parkinson's Disease Questionnaire - 39.;Mental health (Depression, stress, anxiety). Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21questionnaire.;Sleep quality. Timepoint: At baseline and after 12 weeks. Method of measurement: PDSS questionnaire.;Cognitive status. Timepoint: At baseline and after 12 weeks. Method of measurement: AMT questionnaire.;Anthropometric indices. Timepoint: At baseline and after 12 weeks. Method of measurement: Seca scale and portable stadiometer.;Gastrointestinal symptoms. Timepoint: At baseline and after 12 weeks. Method of measurement: Visual Analogue Scale.;Appetite. Timepoint: At baseline and after 12 weeks. Method of measurement: SNAQ Questionnaire.;Fatigue. Timepoint: At baseline and after 12 weeks. Method of measurement: PFS-16 Questionnaire.;Blood pressure. Timepoint: At baseline and after 12 weeks. Method of measurement: Digital sphygmomanometer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Gholamreza Askari
Esfahan University of Medical Sciences
Outcome results
None listed