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IRCT20221122056577N1 IRCT 2024-03-11 Abba Darou Teb Co. Effectiveness of methylcobalamin and alpha lipoic acid in diabetic neuropathy. Comparison of effectiveness of methylcobalamin, alpha lipoic acid and vitamin B groups with placebo to control diabetic neuropathy syndrome in type 2 diabetes. 2023-09-23 anticipated 500 Complete https://irct.ir/trial/67039 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on the multicenter nature of this study, a simple stratified randomization method (Based on centers), using individual randomization within each stratum. To generate the random sequence, the RAND function in Excel software(Version 2302 Build 16.0.16130.20186) was utilized. The concealment of the randomization sequence took place in a location independent of the study site (drug production unit) without the knowledge of the research staff. Labels containing the code of each center and the corresponding patient number were created, and based on the mentioned random sequence and its matching with the designated product type in the sequence, they were affixed to the box containing the respective drug or placebo, ensuring that the research staff and patients remained unaware of the randomization sequence, Blinding description: Aba Darou Teb company placed Dino supplement and placebo in the unique package and label and the code attached to each package with the same deign and distributed between patients by non-notified person while patients and investigators are not informed about type of drugs. Also, health-care and staffs of clinic are not informed about type of drugs. Also, Outcome evaluator and analyzer are not informed about type of drugs. N/A Diabetic neuropathy. 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 (3 mg) and folic acid (0.9 mg). Naturesonly company is the producer of Dino tablets. Intervention 2: Control group: Receiving placebo pill without having any active ingredient with the exact same appearance as the Dino pill, for three months and one a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more data
public Mahsa Ghaffari
Golsa Tower, End of Afshar Alley, South Mofateh, Hafte Tir Squre
Tehran Iran (Islamic Republic of) 1573758915 +98 21 8618 1631 medco.mkt@naturesonly.ir Abba Darou Teb Co. scientific Haleh Chehrehgosha
Medica Faculty, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 1021 chehrehgosha.h@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 80 years Both 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. G99.0 Autonomic neuropathy in endocrine and metabolic diseases Treatment - Drugs Placebo 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 (3 mg) and folic acid (0.9 mg). Naturesonly company is the producer of Dino tablets. Control group: Receiving placebo pill without having any active ingredient with the exact same appearance as the Dino pill, for three months and one a day. 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. 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 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. Abba Darou Teb Co. Approved 2023-09-02 Research Ethics Committees of Iran University of Medical Sciences-school of medicine Central Headquarters Building, Research and Technology Vice-Chancellor, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)