Painful diabetic neuropathy. Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group: 30 patients with painful diabetic neuropathy receiving FamiLact synbiotic containing 10 to 9 CFU of Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acid
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: Diagnosing diabetes based on the patient's record according to the doctor's diagnosis based on the criteria of the American Diabetes Association for at least one year before the start of the study. Diagnosing peripheral diabetic neuropathy based on the patient's record according to the doctor's diagnosis based on the criteria of the American Diabetes Association for at least three months before the start of the study (based on the results of small fiber function, including the feeling of temperature or pinprick, as well as the results of large-fiber function including vibration feeling using 128 Hz tuning fork and 10-g monofilament) Patients aged 35 to 70 years No pregnancy or breastfeeding Stable blood sugar control with an HbA1C level of less than 8% based on the patient's record stably receiving antidiabetic drugs without changing their type and dosage for 30 days before randomization NRS score of at least 4 out of ten averaged over 24 hours per day for at least one week before the start of the study No other chronic diseases such as kidney and liver failure, cancer, etc. Not taking supplements or receiving a special diet in the three months before the start of the study Willingness, contentment, and ability to carry out and complete the study and cooperate with the researcher
Exclusion criteria
Exclusion criteria: People with immunodeficiency, short bowel syndrome (SBS), inflammatory bowel disease People with central venous catheters or heart valve disease People with hypothyroidism and other thyroid disorders People with non-diabetic neuropathies, including drug-induced neuropathy (such as isoniazid and chemotherapy), paraneoplastic neuropathy, spinal cord diseases such as intervertebral disc herniation People with pregnancy or expect to be pregnant during the study, as well as Breastfeeding Mother People receiving drugs or supplements or antibiotics not determined in the research People who, according to the researcher, have psychological, medical, and medicinal characteristics that put their mental and physical health at risk during the study (such as people with severe anxiety, severe depression, mania, dementia, history of drug and alcohol addiction) Inadequate education and/or ability to interview
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood sugar. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: laboratory test.;INSULIN. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: laboratory test.;HOMA-IR. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: calculation.;Type and intensity of pain. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: short form McGill pain questionnaire-2 (SF-MPQ2).;Pain intensity. Timepoint: Before intervention and at the end of each week until the end of the Eighth week. Method of measurement: numeric rating scale questionnaire.;Insomnia Severity. Timepoint: 8 weeks. Method of measurement: Insomnia Severity index questionnaire.;Sleep Interference Scale. Timepoint: Before intervention and at the end of each week until the end of the Eighth week. Method of measurement: Sleep Interference Scale questionnaire.;Quality of life. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: SF-36 quality of life questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: scale.;Body mass index. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: calculation.;Waist circumference. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: ??? ?????.;Systolic blood pressure. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: blood pressure monitor.;Diastolic blood pressure. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: blood pressure monitor. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactManoochehr Amin Amlashi
Iran University of Medical Sciences
Outcome results
None listed