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A Randomized Controlled Trial to Assess the Effect of L-carnitine in Patients With Diabetic Peripheral Neuropathy to Relief Pain and Symptom Improvement

Primary Purpose

Patient Compliance

Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Levocarnitine
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient Compliance focused on measuring DPN, Levocarnitine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

i. Clinically diagnosed diabetic patients who had been on stable antidiabetic therapy for 1 year ii.Age: 18 years to 70 years iii. Patients HbA1c level <10

Exclusion Criteria:

i. Patient who are suffering from other causes of peripheral neuropathy for example chemotherapy and HIV patient, rheumatoid arthritis, SLE, alcololism, vitamin B12 deficiency etc ii. Lactating and pregnant women iii. Patients taking anticonvulsants, antidepressants, opoioids and other neuropathic pain medication agents

Sites / Locations

  • Pharmacology department,BSMMU.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention or group a

Placebo or group b

Arm Description

Diabetic neuropathy patients with antidiabetic therapy in addition with l-carnitine supplementation

Diabetic neuropathy patients with antidiabetic treatment in addition with placebo

Outcomes

Primary Outcome Measures

VAS score
Alleviation of VAS Score of pain

Secondary Outcome Measures

Improvement of neuropathic symptom
Alleviation of NSS and NDS of diabetic neuropathy

Full Information

First Posted
October 29, 2019
Last Updated
October 29, 2019
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04145245
Brief Title
A Randomized Controlled Trial to Assess the Effect of L-carnitine in Patients With Diabetic Peripheral Neuropathy to Relief Pain and Symptom Improvement
Official Title
A Randomized Controlled Trial to Assess the Effect of L-carnitine in Patients With Diabetic Peripheral Neuropathy to Relief Pain and Symptom Improvement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes mellitus. The prevalence rate is approaching towards a peak throughout the world including Bangladesh. The current intervention used in peripheral neuropathy does not bring satisfactory result. Recent trial shows that L-carnitine is effective and safe in DPN. So it is expected that L-carnitine may produce better effect in compared to other medicine used previously for alleviation of DPN.
Detailed Description
: Diabetic peripheral neuropathy is one of the common complication of chronic diabetes mellitus, with a 30-50 % prevalence. Progressive development of pain, numbness in toes or feet and sensory motor disorders affects the patient's quality of life. The epidemic spread of the disease has raised concern among physicians and researchers. A variety of agents or medicines with potential effect have been studied to control development of peripheral neuropathy. The existing management are yet unsatisfactory. Recent studies have suggested that L-carnitine is potential to alleviate symptoms in patents with diabetic neuropathy. Previous trial also indicated the efficacy and safety of L-carnitine on diabetic neuropathy. This limitations have led to search for an effective and tolerable option by placebo controlled trial.The present study is an attempt to investigate the effects of carnitine on pain and symptom improvement of diabetic peripheral neuropathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance
Keywords
DPN, Levocarnitine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Interventional Group- Patients with carnitine in addition to antidiabetic therapy Control Group- Patients with placebo and antidiabetic therapy
Masking
ParticipantInvestigator
Masking Description
placebo controlled, double bind
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention or group a
Arm Type
Experimental
Arm Description
Diabetic neuropathy patients with antidiabetic therapy in addition with l-carnitine supplementation
Arm Title
Placebo or group b
Arm Type
Placebo Comparator
Arm Description
Diabetic neuropathy patients with antidiabetic treatment in addition with placebo
Intervention Type
Drug
Intervention Name(s)
Levocarnitine
Other Intervention Name(s)
Placebo
Intervention Description
Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks
Primary Outcome Measure Information:
Title
VAS score
Description
Alleviation of VAS Score of pain
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Improvement of neuropathic symptom
Description
Alleviation of NSS and NDS of diabetic neuropathy
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: i. Clinically diagnosed diabetic patients who had been on stable antidiabetic therapy for 1 year ii.Age: 18 years to 70 years iii. Patients HbA1c level <10 Exclusion Criteria: i. Patient who are suffering from other causes of peripheral neuropathy for example chemotherapy and HIV patient, rheumatoid arthritis, SLE, alcololism, vitamin B12 deficiency etc ii. Lactating and pregnant women iii. Patients taking anticonvulsants, antidepressants, opoioids and other neuropathic pain medication agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farhana Haque, MBBS
Phone
01734342464
Email
farhanahaque857@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zesmin Dewan, PHD
Phone
01712533169
Email
jfdewan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhana Haque, MBBS
Organizational Affiliation
Resident, phase-B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacology department,BSMMU.
City
Dhaka
State/Province
Dhaka,Sahbagh
ZIP/Postal Code
02
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farhana Haque, MBBS
Phone
01734342464
Email
farhanahaque857@gmail.com
First Name & Middle Initial & Last Name & Degree
Zesmin Dewan, PHD
Phone
01712533169
Email
jfdewan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized Controlled Trial to Assess the Effect of L-carnitine in Patients With Diabetic Peripheral Neuropathy to Relief Pain and Symptom Improvement

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