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

NCT04145245 | Unknown Phase 2

• 1 other identifier: BSMMU/2019/3936
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Compliance

Keywords

DPN, Levocarnitine

Outcome Measures

Primary Outcomes (1)

• VAS score

  Alleviation of VAS Score of pain

  10 weeks

Secondary Outcomes (1)

• Improvement of neuropathic symptom

  10 weeks

Study Arms (2)

Intervention or group a

EXPERIMENTAL

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

Drug: Levocarnitine

Placebo or group b

PLACEBO COMPARATOR

Diabetic neuropathy patients with antidiabetic treatment in addition with placebo

Drug: Levocarnitine

Interventions

Levocarnitine DRUG

Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks

Also known as: Placebo

Intervention or group a; Placebo or group b

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Pharmacology department,BSMMU.

Dhaka, Dhaka,Sahbagh, 02, Bangladesh

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Farhana Haque, MBBS

  Resident, phase-B

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farhana Haque, MBBS

CONTACT

01734342464; farhanahaque857@gmail.com

Zesmin Dewan, PHD

CONTACT

01712533169; jfdewan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: placebo controlled, double bind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Farhana Haque

Model Details: Interventional Group- Patients with carnitine in addition to antidiabetic therapy Control Group- Patients with placebo and antidiabetic therapy

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 30, 2019
• Study Start: April 17, 2018
• Primary Completion: December 30, 2019
• Study Completion: February 28, 2020
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)