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NOT YET RECRUITING
NCT07683598
NA

DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy

Sponsor: RS H Adam Malik

View on ClinicalTrials.gov

Summary

This study will evaluate the effect of DLBS1033 as adjunctive therapy in patients with diabetic neuropathy. Diabetic neuropathy is a common complication of diabetes that can cause numbness, tingling, pain, impaired nerve function, and reduced quality of life. Participants with diabetic neuropathy will be randomly assigned to receive either DLBS1033 plus standard therapy or placebo plus standard therapy. The study will assess changes in nerve conduction study parameters, Toronto Clinical Neuropathy Score, interleukin-8, Galectin-3, and quality of life. The purpose of this study is to determine whether DLBS1033 may provide additional benefit as an adjunctive therapy for diabetic neuropathy.

Official title: Effect of DLBS1033 as Adjunctive Therapy on Changes in Nerve Conduction Study Parameters, Toronto Clinical Neuropathy Score, Interleukin-8, Galectin-3, and Quality of Life in Patients With Diabetic Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-08-01

Completion Date

2027-03-01

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

DLBS1033

DLBS1033 is a standardized bioactive extract derived from Lumbricus rubellus. Participants assigned to the intervention arm will receive DLBS1033 1 capsule orally three times daily for 12 weeks, in addition to standard therapy for diabetic neuropathy.

DIETARY_SUPPLEMENT

Placebo

Participants assigned to the control arm will receive a matching placebo capsule orally three times daily for 12 weeks, in addition to standard therapy for diabetic neuropathy.

Locations (1)

RS H Adam Malik

Medan, North Sumatera, Indonesia