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The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

NCT04689971 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-30

No results posted yet for this study

Summary

Large population-based study has shown that the prevalence of painful diabetic neuropathy (PDN) is around 21%, and painful symptoms are more prevalent in patients with type 2 diabetes, females, and Asians. PDN is characterized by symmetrical lower limb paresthesiae, dysesthesiae, lancinating pains and allodynia, with nocturnal exacerbation. PDN cause sleep disturbance and reduce quality of life. The international guidelines advocate a range of therapies for symptom relief. The therapeutic efficacy for all recommended medications is at best around 50% pain relief and is limited due to unwanted side effects. Apart from peripheral and central alterations, metabolic alterations such as increased glycemic influx, and elevated plasma methylglyoxal levels have been implicated in the pathogenesis of PDN.

Several treatment options for PN are available, including pharmacological, non-pharmacological, and alternative options. Patients suffering from severe and disabling symptoms (e.g. NeP) may require guideline treatments like pregabalin, duloxetine, or gabapentin initially until the symptoms are under control. These medications can symptomatically relieve NeP; however, they do not address the underlying cause. Other options such as neurotropic B vitamins (B1, B6, and B12) do not only target the symptoms, but also improve nerve health and contribute to nerve regeneration. The B vitamins are commonly used for PN treatment in clinical practice worldwide, this treatment option is most suitable before the patient suffers from chronic NeP. However, co-treatment with neurotropic B vitamins is also appropriate in NeP patients, to ensure the restoration of nerve health.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

Standard therapy

Gabapentin, pregabalin, or amitriptyline

DRUG

Vitamin B combination

Vitamin B combination (B1 100 mg, B2 200 mg and B12 200 mcg) tablet once daily

Sponsors & Collaborators

  • PT SOHO Global Health Tbk

    collaborator UNKNOWN

  • Duta Wacana Christian University

    lead OTHER

Principal Investigators

  • Rizaldy Pinzon, MD, MSc, PhD · Duta Wacana Christian University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04689971 on ClinicalTrials.gov