IRCT | Comparison of effectiveness of methylcobalamin, alpha lipoic acid and vitamin B groups with placebo to control diabetic neuropathy syndrome in type 2 diabetes.

Protocol summary

Study aim: Primary Objective: To compare the efficacy of a daily dose of Dino versus a placebo on diabetic peripheral neuropathy (DPN) symptoms. Secondary Objectives: To evaluate the clinical safety of Dino in patients with diabetic peripheral neuropathy.
Design: To demonstrate the clinical efficacy, a clinical trial has been conducted involving 500 patients distributed across 8 centers in Iran, with 4 centers in Tehran and 4 centers in the provinces. The trial includes control and intervention groups, utilizing a parallel, double-blind, and randomized design. This study represents a post-market clinical trial conducted as a post marketing study. Stats Direct software was employed for randomization.
Settings and conduct: The patients with type 2 diabetes referring to 8 center will be selected for this study and randomly placed experimental or placebo group in the study centers,Tehran, Esfahan, Shiraz, Tabriz, Mashhad and Dino tablet and placebo will be given to patients randomly with the same similar packaging and investigators, patients are blinded, primary outcome is considered as scale of improvement of diabetic neuropathic symptom in these patients.
Participants/Inclusion and exclusion criteria: Inclusion criteria: patients aged 18-80 years, diabetic neuropathy, neuropathic pain, numbness, tingling & burning sensation. Exclusion criteria: peripheral vascular disease, Pregnant or lactating women, Stroke, Alzheimer's Disease, Bell's Palsy, Parkinson's Disease, Epilepsy and Seizures, psychiatric and other neurological disorders
Intervention groups: Diabetic patients with peripheral neuropathy receiving the Dino tablet. Diabetic patients with peripheral neuropathy receiving placebo tablet.
Main outcome variables: tingling; Numbness; Pins and needles; Pain; vibration Sens

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20221122056577N1

Registration date: 2024-03-11, 1402/12/21

Registration timing: registered_while_recruiting

Last update: 2024-03-11, 1402/12/21

Update count: 0
Registration date: 2024-03-11, 1402/12/21

Registrant information: Name

Mahsa Ghaffari

Name of organization / entity

Abba Daroo Teb

Country

Iran (Islamic Republic of)

Phone

+98 21 8618 1631

Email address

medco.mkt@naturesonly.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-09-23, 1402/07/01
Expected recruitment end date: 2024-11-23, 1403/09/03
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of effectiveness of methylcobalamin, alpha lipoic acid and vitamin B groups with placebo to control diabetic neuropathy syndrome in type 2 diabetes.

Public title: Effectiveness of methylcobalamin and alpha lipoic acid in diabetic neuropathy.
Purpose: Supportive
Inclusion/Exclusion 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:

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.
Age: From 18 years old to 80 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor

Sample size

Target sample size: 500

Randomization (investigator's opinion)

Randomized

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 (investigator's opinion)

Double blinded

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.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of Iran University of Medical Sciences-school of medicine

Street address

Central Headquarters Building, Research and Technology Vice-Chancellor, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway

City

Tehran

Province

Tehran

Postal code

1449614535
Approval date: 2023-09-02, 1402/06/11
Ethics committee reference number: IR.IUMS.FMD.REC.1402.268

Health conditions studied

1

Description of health condition studied: Diabetic neuropathy
ICD-10 code: G99.0
ICD-10 code description: Autonomic neuropathy in endocrine and metabolic diseases

Primary outcomes

1

Description: 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 outcomes

1

Description: 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.

2

Description: 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.

3

Description: 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.

Intervention groups

1

Description: 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.
Category: Treatment - Drugs

2

Description: 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.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Nikan Hospital

Full name of responsible person

Vahid Yousefi

Street address

No. 6, Arag St., Artesh Blvd, Aghdasieh

City

Tehran

Province

Tehran

Postal code

1937836814

Phone

+98 21 2912 0000

Email

yousefivahid15@gmail.com

2

Recruitment center: Name of recruitment center

Dr. Yousefi office

Full name of responsible person

Vahid Yousefi

Street address

1st floor, Physician Biulding 120, Rahmani Alley, Between 2nd and 3th Square, Tehranpars

City

Tehran

Province

Tehran

Postal code

1655815711

Phone

+98 21 4219 8592

Email

yousefivahid15@gmail.com

3

Recruitment center: Name of recruitment center

Dr. Nikousokhan Office

Full name of responsible person

Amir Kamran Nikousokhan

Street address

No.17, Shohada Alley, Uper of Motahari St., Mirzaye Shirazi St.

City

Tehran

Province

Tehran

Postal code

1586744744

Phone

+98 21 8872 8237

Email

amirkamranniko@yahoo.com

4

Recruitment center: Name of recruitment center

Dr. Samadani Fard Office

Full name of responsible person

Seyed Hossein Samadani Fard

Street address

No.5, First of Patris Lomomba St., After Bagherkhan, Sattarkhan St.

City

Tehran

Province

Tehran

Postal code

1443633133

Phone

+98 21 6691 5127

Email

samadanifard.h@iums.ac.ir

5

Recruitment center: Name of recruitment center

Parsian Diabetes Clinic

Full name of responsible person

Aliakbar Raouf Saeb

Street address

No.328, In Front of Subway Station, Bisim Crossroads, Lashgar Crossroads, Bahar St.

City

Mashhad

Province

Razavi Khorasan

Postal code

9137714315

Phone

+98 51 3858 4040

Email

dr.raoof@yahoo.com

6

Recruitment center: Name of recruitment center

Dr. Goharian Office

Full name of responsible person

Amir Reza Goharian

Street address

Ground Floor, Block T, Sakht Ajand Building, Amadgah St.

City

Isfahan

Province

Isfehan

Postal code

8145615957

Phone

+98 31 3224 0884

Email

amirreza.goharian@gmail.com

7

Recruitment center: Name of recruitment center

Dr. Shokrani Office

Full name of responsible person

Rahim Shokrani Houshmand

Street address

Emrouz Building, Taleghani Intersection, 17th Shahrivar St.

City

Tabriz

Province

East Azarbaijan

Postal code

5137718189

Phone

+98 41 3554 8135

Email

shokrani_dr@yahoo.com

8

Recruitment center: Name of recruitment center

Dr. Danafar office

Full name of responsible person

Faride Danafar

Street address

2nd Floor, Radiography Tabesh Building, Crossroad of Moaddel and Souratgar Ave.

City

Shiraz

Province

Fars

Postal code

7134963479

Phone

+98 71 3231 3234

Email

danafar22@yhoo.com

1

Sponsor: Name of organization / entity

Abba Darou Teb Co.

Full name of responsible person

Ali Mansouri Mehrabani

Street address

Golsa Tower, End of Afshar Alley, South Mofateh, Hafte Tir Squre.

City

Tehran

Province

Tehran

Postal code

1573758915

Phone

+98 21 8618 1631

Email

mansouri@naturesonly.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Abba Darou Teb Co.
Proportion provided by this source: 100
Public or private sector: Private
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Industry

Person responsible for general inquiries

Contact: Name of organization / entity

Abba Darou Teb Co.

Full name of responsible person

Mahsa Ghaffari

Position

Medico-Marketing Manager

Latest degree

Medical doctor

Other areas of specialty/work

Medical Pharmacy

Street address

Golsa Tower, End of Afshar Alley, South Mofateh, Hafte Tir Squre

City

Tehran

Province

Tehran

Postal code

1573758915

Phone

+98 21 8618 1631

Email

medco.mkt@naturesonly.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Haleh Chehrehgosha

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Medical Education

Street address

Medica Faculty, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 8670 1021

Email

chehrehgosha.h@iums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Haleh Chehrehgosha

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Medical Education

Street address

Medical Faculty, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 8670 1021

Email

chehrehgosha.h@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Comparison of effectiveness of methylcobalamin, alpha lipoic acid and vitamin B groups with placebo to control diabetic neuropathy syndrome in type 2 diabetes.