An interventional study of DLBS1033 and Placebo in Diabetic Neuropathy, sponsored by RS H Adam Malik. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by RS H Adam Malik · Not applicable, Interventional, and Treatment
Among 12 studies in Diabetic Neuropathies with a site in Indonesia — 3 open to participants now, 4 under way, 1 of them phase 3. Diabetic Neuropathies · Indonesia.
Among the 12 studies in Diabetic Neuropathies with a site in Indonesia, this one is the 5th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2026, is one of 6 with no phase, and was the 12th registered.
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
Browse Diabetic Neuropathies studies →3 of the 12 studies in Diabetic Neuropathies with a site in Indonesia are open now. Recruiting first, the newest first:
Universitas Sebelas Maret · Sites in Indonesia
Ages 40–60
Andina Setyawati · Sites in Indonesia
Ages 20–70
A study can be open while its sites in Indonesia have not opened yet or have stopped. Only those recruiting at a site in Indonesia →
Of the 52 Diabetic Neuropathies studies recruiting now, 21 (40%) set no upper age limit and 24 (46%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
Median enrollment 80 across the 11 interventional studies, 78 across the 1 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 12 have an industry lead sponsor. The 10 most frequent:
RS H Adam Malik is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
RS H Adam Malik has 1 study filed under Diabetic Neuropathies — fewer than ten, so there is no comparison to draw.
2 of the studies in Diabetic Neuropathies with a site in Indonesia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07229794St Elisabeth School Health ScienceEffect of Foot-ankle Exercise Using Elastic Band | 2026-11-30 |
| NCT07683598RS H Adam MalikDLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy | 2027-02-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 12 studies in Diabetic Neuropathies with a site in Indonesia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive DLBS1033 as adjunctive therapy in addition to standard therapy for diabetic neuropathy for 12 weeks.
Dietary Supplement: DLBS1033
Participants in this arm will receive placebo in addition to standard therapy for diabetic neuropathy for 12 weeks.
Dietary Supplement: Placebo
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.
Also known as: Lumbricus rubellus Extract
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.
Also known as: Placebo capsule
Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at 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.
Time frame: Baseline and week 12
Change From Baseline in Distal Latency Assessed by Nerve Conduction Study at 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.
Time frame: Baseline and week 12
Change From Baseline in Nerve Response Amplitude Assessed by Nerve Conduction Study at 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.
Time frame: Baseline and week 12
Change From Baseline in Toronto Clinical Neuropathy Score During 12 Weeks
Clinical neuropathy severity will be assessed using the Toronto Clinical Neuropathy Score. The total score ranges from 0 to 19, with higher scores indicating more severe neuropathy. Scores of 0-5 indicate no neuropathy, 6-8 mild neuropathy, 9-11 moderate neuropathy, and 12 or higher severe neuropathy. Change from baseline to week 4, week 8, and week 12 will be compared between groups.
Time frame: Baseline, week 4, week 8, and week 12
Change From Baseline in Serum Interleukin-8 Level at Week 12
Serum interleukin-8 level will be measured using enzyme-linked immunosorbent assay and reported in picograms per milliliter. Change from baseline to week 12 will be compared between groups.
Time frame: Baseline and week 12
Change From Baseline in Serum Galectin-3 Level at Week 12
Serum Galectin-3 level will be measured using enzyme-linked immunosorbent assay and reported in nanograms per milliliter. Change from baseline to week 12 will be compared between groups.
Time frame: Baseline and week 12
Change From Baseline in Short Form-36 Quality of Life Score During 12 Weeks
Quality of life will be assessed using the Short Form-36 questionnaire. Scores range from 0 to 100, with higher scores indicating better quality of life. Change from baseline to week 4, week 8, and week 12 will be compared between groups.
Time frame: Baseline, week 4, week 8, and week 12
Plan to share: No — Individual participant data will not be shared because the data contain confidential patient information and there is no current plan for public data sharing.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Feb 2027, 6 months later.
Of 137 non-industry interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 6 months is below that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: DLBS 1033
RS H Adam Malik