Evaluation of the therapeutic effects of saffron on clinical and electrodiagnostic symptoms of patients with type 2 diabetes

Phase 3

Recruiting

Conditions: type 2 diabetes.
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
E08.40

Registration Number: IRCT20100127003217N13

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in laboratory parameters associated with type 2 diabetes. Timepoint: before intervention and 3 months after intervention. Method of measurement: Calorimetric enzymatic.