]>
IRCT20100127003217N13 IRCT 2020-12-04 Tabriz University of Medical Sciences Evaluation of the therapeutic effects of saffron on clinical and electrodiagnostic symptoms of patients with type 2 diabetes Evaluation of the therapeutic effects of saffron (Crocus sativus) on clinical and electrodiagnostic symptoms of patients with type 2 diabetes: a double-blind clinical trial 2020-12-21 anticipated 60 Complete https://irct.ir/trial/52651 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will performed using random blocking with block sizes 10 and 1: 1 assignment ratio using Random allocation software (RAS) software, Blinding description: According to the double-blind nature of this study, a person who has no role in the intervention performs randomization and assigns patients to intervention or placebo groups based on the random sequence . Another person who is unaware of patient allocation proscribes drugs according to codes. This randomization and assignment of codes will remain hidden from researchers and participants until the statistical analysis is completed. 3 type 2 diabetes. 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 . Intervention 2: Control group: Placebo group will receive daily two capsules containing cornstarch flours orally which will be prepared in the geriatrics center for 3 months. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: starting in March 2022 To whom: only available for people working in academic institutions Conditions: For Meta-analysis only Where to obtain: دکتر فریبا اسلامیان: Eslamiyanf@tbzmed.ac.ir How to obtain: Will be done for documented and registered requests Comments:
public Fariba Eslamiyan
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3967 eslamiyanf@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Fariba Eslamiyan
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3967 Eslamiyanf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Drugs Treatment - Drugs 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 . Control group: Placebo group will receive daily two capsules containing cornstarch flours orally which will be prepared in the geriatrics center for 3 months 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. Changes in laboratory parameters associated with type 2 diabetes. Timepoint: before intervention and 3 months after intervention. Method of measurement: Calorimetric enzymatic. Tabriz University of Medical Sciences Approved 2020-10-26 Ethics committee of Tabriz University of Medical Sciences Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor Tabriz East Azarbaijan Iran (Islamic Republic of)