DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy

Starting soon · Not applicable · Has a placebo group

Conditions studied: Diabetic Neuropathy

In brief

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.

Key facts

Study ID

NCT07683598

Run by

RS H Adam Malik

People needed

80

Starts

2026-08-01

Expected to finish

2027-03-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with diabetic neuropathy based on symptoms and clinical signs of peripheral neuropathy and a Toronto Clinical Neuropathy Score (TCNS) of 6 or higher, representing mild to severe neuropathy.
• Age 18 years or older.
• Willing to participate in the study and sign the informed consent form.
• Able to complete the study procedures and complete the Short Form-36 quality of life questionnaire independently or with assistance from the investigator if needed.

You may not qualify if…

• Participants with other conditions that may cause non-diabetic peripheral neuropathy, including history of chemotherapy, use of anti-tuberculosis drugs such as isoniazid, heavy alcohol consumption, chronic kidney disease, liver cirrhosis, vitamin B12 deficiency, hypothyroidism, HIV/AIDS, hereditary neuropathy, or neuromuscular disease affecting the peripheral nerves.
• Participants with acute infection or active inflammatory conditions that may affect interleukin-8 and Galectin-3 levels at the time of sample collection before or after intervention, such as acute infection with fever, infection with systemic manifestations, active malignancy, or active inflammatory autoimmune disease.
• Allergy or history of hypersensitivity to the active ingredient of DLBS1033.
• Currently receiving another experimental therapy or participating in another clinical study.
• Pregnant or breastfeeding women.

Where it is running

• RS H Adam Malik — Medan, North Sumatera, Indonesia

Full record on ClinicalTrials.gov

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