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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

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
Overall Status
Unknown status
CT.gov ID
NCT04145245
Collaborator
(none)
104
Enrollment
1
Location
2
Arms
22.4
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Interventional Group- Patients with carnitine in addition to antidiabetic therapy Control Group- Patients with placebo and antidiabetic therapyInterventional Group- Patients with carnitine in addition to antidiabetic therapy Control Group- Patients with placebo and antidiabetic therapy
Masking:
Double (Participant, Investigator)
Masking Description:
placebo controlled, double bind
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 17, 2018
Anticipated Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention or group a

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

Drug: Levocarnitine
Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks
Other Names:
  • Placebo

    		•
    Placebo Comparator: Placebo or group b

    Diabetic neuropathy patients with antidiabetic treatment in addition with placebo

    Drug: Levocarnitine
    Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VAS score [10 weeks]

      Alleviation of VAS Score of pain

    Secondary Outcome Measures

    1. Improvement of neuropathic symptom [10 weeks]

      Alleviation of NSS and NDS of diabetic neuropathy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 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:
    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pharmacology department,BSMMU. Dhaka Dhaka,Sahbagh Bangladesh 02

    Sponsors and Collaborators

    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    Investigators

    • Principal Investigator: Farhana Haque, MBBS, Resident, phase-B

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Farhana Haque, Farhana Haque, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    ClinicalTrials.gov Identifier:
    NCT04145245
    Other Study ID Numbers:
    • BSMMU/2019/3936
    First Posted:
    Oct 30, 2019
    Last Update Posted:
    Oct 30, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Farhana Haque, Farhana Haque, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    DPN, Levocarnitine
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Oct 30, 2019