DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy

Официальное название

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

Обзор

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.

Подробное описание

Diabetic neuropathy is one of the most common chronic complications of diabetes mellitus and may lead to sensory symptoms, neuropathic pain, impaired peripheral nerve function, and decreased quality of life. Its pathogenesis involves chronic hyperglycemia, oxidative stress, inflammation, endothelial dysfunction, and impaired microcirculation of the peripheral nerves. Current pharmacological treatment is mainly directed toward symptom control, while therapies targeting microcirculatory and inflammatory mechanisms remain limited.

DLBS1033 is a standardized bioactive extract derived from Lumbricus rubellus. It has fibrinolytic, fibrinogenolytic, antithrombotic, antiplatelet, and anti-inflammatory properties. Based on these mechanisms, DLBS1033 may have potential as an adjunctive therapy in diabetic neuropathy by improving microcirculation and modulating inflammatory pathways.

This study is an experimental analytical study with a randomized controlled trial design involving two parallel groups. Eligible patients with diabetic neuropathy at RS H Adam Malik will be recruited consecutively and randomly assigned to either the intervention group or the control group. The intervention group will receive DLBS1033 as adjunctive therapy in addition to standard therapy, while the control group will receive placebo in addition to standard therapy.

Participants will be followed for 12 weeks. Clinical neuropathy severity and quality of life will be assessed at baseline and then monthly during the follow-up period using the Toronto Clinical Neuropathy Score and the Short Form-36 questionnaire. Nerve conduction study parameters and inflammatory biomarkers will be assessed at baseline and again after 12 weeks of treatment. Nerve conduction study parameters will include nerve conduction velocity, distal latency, and amplitude. Inflammatory biomarkers will include interleukin-8 and Galectin-3 levels.

The study is expected to provide clinical evidence regarding the potential role of DLBS1033 as adjunctive therapy for patients with diabetic neuropathy, particularly in relation to electrophysiological changes, clinical neuropathy severity, inflammatory biomarkers, and quality of life.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at Week 12 [Срок оценки: Baseline and week 12]
• Change From Baseline in Distal Latency Assessed by Nerve Conduction Study at Week 12 [Срок оценки: Baseline and week 12]
• Change From Baseline in Nerve Response Amplitude Assessed by Nerve Conduction Study at Week 12 [Срок оценки: Baseline and week 12]

Вторичные конечные точки (4)

• Change From Baseline in Toronto Clinical Neuropathy Score During 12 Weeks [Срок оценки: Baseline, week 4, week 8, and week 12]
• Change From Baseline in Serum Interleukin-8 Level at Week 12 [Срок оценки: Baseline and week 12]
• Change From Baseline in Serum Galectin-3 Level at Week 12 [Срок оценки: Baseline and week 12]
• Change From Baseline in Short Form-36 Quality of Life Score During 12 Weeks [Срок оценки: Baseline, week 4, week 8, and week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• RS H Adam Malik — Medan

Идентификаторы

NCT: NCT07683598 · DN-DLBS1033-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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