Diabetic neuropathy. Autonomic neuropathy in endocrine and metabolic diseases
Conditions
Interventions
Intervention 1: Intervention group: This group takes one Dino tablet daily for three months, which contains methyl cobalamin (1500 micrograms), alpha lipoic acid (100 mg), thiamine (10 mg), pyridoxine
Sponsors
Abba Darou Teb Co.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Male or female patients with diabetes mellitus type 2 and having peripheral neuropathy symptoms with =2 neuropathic pain scale scores. The age group must be between 18-80 years old. Symptomatic conditions with neuropathic pain, numbness, tingling & burning sensation in the extremities for at least 1 month before enrolling in the study. Consent and compliance with all aspects of the study protocol, methods, and providing data during follow up contact.
Exclusion criteria
Exclusion criteria: Presence of foot ulcer. Presence of peripheral vascular disease (non-palpable foot pulses, intermittent claudication). Patients who are contraindicated with Methylcobalamin, Alphalipoic acid, folic acid, or vitamin B6 and B1 usage. Pregnant or lactating women. Patients with a history or presence of Stroke, Alzheimer's Disease, Bell's Palsy, Parkinson's Disease, Epilepsy and Seizures, psychiatric and other neurological disorders. Patients who are known cases of the kidney disorders. Hypothyroidism. Decompensated cirrhosis. Patients who consume alcohol or have a history of alcohol dependency followed by any current use. Current use or history of having received study investigational drugs or participated in any other clinical trial which ended in the preceding three months or is currently ongoing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of diabetic neuropathy. Timepoint: Investigation of parameters would be performed throughout the treatment period followed by visit-I (baseline), visit-II (week 4), visit-III (week 8), and visit-IV (week 12). Method of measurement: Vibration perception thresholds (VPT) through Biothesiometer, Visual Analog Scale (VAS), and Neuropathic Pain Scale (NPS) would be used to assess the patients on all four visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety of Dino. Timepoint: safety assessed during the course of study following Visit I (baseline), Visit II (week 4), Visit III (week 8), and Visit IV (week 12). Method of measurement: For the analysis of secondary outcomes, all adverse drug reactions such as skin rash, nausea, gastrointestinal intolerance, or hypersensitivity to product components will be recorded through examination by the relevant study physician at all study visits, reviewed, and documented in the respective checklist(vital signs checklist) and reported by ADR questionnaire . Other vital signs will also be measured at each visit to detect potential hidden side effects and will be recorded and documented in the respective checklist(vital signs checklist). For instance, pulse rate will be measured using a digital pulse meter. Oxygen saturation will be measured using a pulse oximeter with the brand name Beurer and model type PO30. Similarly, respiratory rate will be manually counted by the researcher, and blood pressure will be measured using an Omron blood pressure monitor with model type M2 and as mentioned, it is recorded in the vital signs checklist.;Examination of potential side effects, including skin rash. Timepoint: Adverse effects are evaluated during the course of study following Visit I (baseline), Visit II (week 4), Visit III (week 8), and Visit IV (week 12). Method of measurement: For the analysis of secondary outcomes, all adverse drug reactions such as skin rash will be recorded through examination by the relevant study physician at all study visits, reviewed, and documented in the respective checklist(vital signs checklist) and reported by ADR questionnaire.;Examination of potential side effects, including nausea. Timepoint: Adverse effects are evaluated during the course of study following Visit I (baseline), Visit II (week 4), Visit III (week 8), and Visit IV (week 12). Method of measurement: For the analysis of secondary outcomes, all adverse drug reactions such as nausea | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahsa Ghaffari
Abba Darou Teb Co.
Outcome results
None listed