type 2 diabetes. Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Treatment group will receive daily two capsules containing aqueous extract of saffron (50 mg) orally which will be prepared in the geriatrics center for 3 months .
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Having type 2 diabetes Symptoms of sensory neuropathy such as numbless, burning and pain, muscle weakness, atrophy and balance disorders Age more than 18 years Body mass index (BMI) 18.5–35 kg / m Recent diagnosis (maximum 3 months) of type 2 diabetes Willingness to participate in the study
Exclusion criteria
Exclusion criteria: Having type 1 diabetes Gestational diabetes or other specific types of diabetes Insulin therapy over the past three months Having serious gastrointestinal (GI) diseases including peptic ulcers and gastrointestinal bleeding Having an autoimmune disease Osteoarthritis (due to masking the symptoms of neuropathy) Having a history of inherited neuropathy Chronic uremia Allergy to saffron Use of drugs that affect on the symptoms of neuropathy such as antidepressants and anticonvulsants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction on the risk of clinical symptoms of neuropathy. Timepoint: before intervention and 3 months after intervention. Method of measurement: Michigan Questionnaire.;Changes in electrodiagnostic of neuropathy. Timepoint: before intervention and 3 months after intervention. Method of measurement: Electromyography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in laboratory parameters associated with type 2 diabetes. Timepoint: before intervention and 3 months after intervention. Method of measurement: Calorimetric enzymatic. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFariba Eslamiyan
Tabriz University of Medical Sciences
Outcome results
None listed