The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy (NCT07475065) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy
Indonesia34 participantsStarted 2026-03-01
Plain-language summary
This study aims to evaluate whether oral DLBS1033 can improve clinical symptoms and biological markers of nerve damage in adults with diabetic polyneuropathy. The trial enrolls patients with type 2 diabetes who show clinical signs of peripheral nerve injury.
Participants will receive either DLBS1033 as adjuvant therapy or standard therapy alone for 28 days. The study will compare changes in neuropathy severity (Toronto Clinical Neuropathy Score), inflammatory biomarkers (TNF-α), neuroregeneration biomarkers (Nerve Growth Factor), and sensory nerve conduction parameters of the sural nerve between the two groups. Blood tests, clinical assessments, and nerve conduction studies will be performed at baseline and follow-up visits. Participants will also report any symptoms or adverse events throughout the study.
Who can participate
Age range
40 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 40-60 years diagnosed with diabetic polyneuropathy by a neurologist or neurology resident.
* Patients with HbA1c levels between 7-10% within the past 30 days.
* Willing to participate and able to sign the informed consent form.
Exclusion Criteria:
* Pregnant, breastfeeding, or planning pregnancy.
* History of other neurological diseases such as stroke, myelopathy, alcoholic neuropathy, or compressive radiculopathy.
* Significant renal impairment (creatinine \> 1.5× upper limit of normal), hepatic impairment (SGOT or SGPT \> 3× upper limit of normal), or severe cardiac disease (NYHA class III-IV heart failure).
* History of alcohol consumption for ≥ 5 consecutive years.
* Heavy smoker (Brinkman Index \> 600).
* Known allergy or intolerance to DLBS1033.
* Autoimmune disease, malignancy, or acute and/or chronic inflammatory conditions other than diabetic polyneuropathy.
* Participation in another interventional pharmacological clinical study within 30 days prior to screening.
* Currently taking anti-inflammatory and/or antioxidant medications.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Toronto Clinical Neuropathy Score (TCNS)