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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization will be performed by the Group Clinical Research Manager of PT Dexa Medica using permuted block randomization with a block size of 4 and a computer-generated random sequence. The randomization code and blinding code will be prepared and kept confidential by this party. Participants, investigators, and outcome assessors will remain unaware of treatment allocation until study completion, except in a medical emergency requiring unblinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 DLBS
- •Currently receiving another experimental therapy or participating in another clinical study.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at Week 12
时间窗: Baseline and week 12
Nerve conduction velocity will be assessed using nerve conduction study and reported in meters per second. Change from baseline to week 12 will be compared between groups.
Change From Baseline in Distal Latency Assessed by Nerve Conduction Study at Week 12
时间窗: Baseline and week 12
Distal latency will be assessed using nerve conduction study and reported in milliseconds. Change from baseline to week 12 will be compared between groups.
Change From Baseline in Nerve Response Amplitude Assessed by Nerve Conduction Study at Week 12
时间窗: Baseline and week 12
Nerve response amplitude will be assessed using nerve conduction study and reported in millivolts for motor nerve responses and microvolts for sensory nerve responses. Change from baseline to week 12 will be compared between groups.
次要结局
- Change From Baseline in Toronto Clinical Neuropathy Score During 12 Weeks(Baseline, week 4, week 8, and week 12)
- Change From Baseline in Serum Interleukin-8 Level at Week 12(Baseline and week 12)
- Change From Baseline in Serum Galectin-3 Level at Week 12(Baseline and week 12)
- Change From Baseline in Short Form-36 Quality of Life Score During 12 Weeks(Baseline, week 4, week 8, and week 12)
研究者
Putri Gily De La Glory Ginting
Resident, Department of Neurology
RS H Adam Malik