Diabetic NeuropathyNCT07683598
DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy
A study testing DLBS1033 in people with Diabetic Neuropathy, run by RS H Adam Malik at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- DLBS1033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
RS H Adam Malik
Medan, North Sumatera, 20136
Putri Gily De La Glory Ginting, MD, +6282276141617, putriginting99@gmail.com
Putri Gily De La Glory Ginting, Medical Doctor
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Diabetic Neuropathy
- Being tested
- DLBS1033, Placebo
- Keywords
- DLBS1033, Lumbricus rubellus, Nerve Conduction Study, Toronto Clinical Neuropathy Score, Interleukin-8, Galectin-3, Quality of Life, SF-36
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1033Dietary supplement
Also called Lumbricus rubellus Extract
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.
PlaceboDietary supplement
Also called Placebo capsule
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.
| Study group | Role | What they receive |
|---|---|---|
| DLBS1033 Plus Standard Therapy | Experimental | Participants in this arm will receive DLBS1033 as adjunctive therapy in addition to standard therapy for diabetic neuropathy for 12 weeks. Receives: Dietary Supplement: DLBS1033 |
| Placebo Plus Standard Therapy | Placebo comparator | Participants in this arm will receive placebo in addition to standard therapy for diabetic neuropathy for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 4, week 8, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial with two parallel groups. Participants will be assigned to receive either DLBS1033 plus standard therapy or placebo plus standard therapy for 12 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RS H Adam Malik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putri Gily De La Glory Ginting, RS H Adam Malik
- Investigators
- Putri Gily De La Glory Ginting, Medical Doctor, Principal investigator, Department of Neurology, RS H Adam Malik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683598
- Sponsor's protocol ID
- DN-DLBS1033-001
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07683598
- Acronym / sponsor ID
- DN-DLBS1033-001
- Conditions
- Diabetic Neuropathy
- Keywords
- DLBS1033, Lumbricus rubellus, Nerve Conduction Study, Toronto Clinical Neuropathy Score, Interleukin-8, Galectin-3, Quality of Life, SF-36
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RS H Adam MalikUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial with two parallel groups. Participants will be assigned to receive either DLBS1033 plus standard therapy or placebo plus standard therapy for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| DLBS1033 Plus Standard Therapy | Experimental | Dietary Supplement: DLBS1033Participants in this arm will receive DLBS1033 as adjunctive therapy in addition to standard therapy for diabetic neuropathy for 12 weeks. |
| Placebo Plus Standard Therapy | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive placebo in addition to standard therapy for diabetic neuropathy for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLBS1033Also: Lumbricus rubellus ExtractDLBS1033 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. | Dietary supplement | DLBS1033 Plus Standard Therapy |
| PlaceboAlso: Placebo capsuleParticipants 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. | Dietary supplement | Placebo Plus Standard Therapy |
Primary outcome
Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at Week 12
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change From Baseline in Toronto Clinical Neuropathy Score During 12 Weeks
Time frame: Baseline, week 4, week 8, and week 12
Change From Baseline in Serum Interleukin-8 Level at Week 12
Time frame: Baseline and week 12
Change From Baseline in Serum Galectin-3 Level at Week 12
Time frame: Baseline and week 12
Change From Baseline in Short Form-36 Quality of Life Score During 12 Weeks
Time frame: Baseline, week 4, week 8, and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Putri Gily De La Glory Ginting, Medical Doctor principal investigator
Department of Neurology, RS H Adam Malik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLBS1033 in people with Diabetic Neuropathy, run by RS H Adam Malik at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Putri Gily De La Glory Ginting, Medical Doctor (+6282276141617, putriginting99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at Week 12 (time frame: Baseline and week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.