DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy

NCT07683598 | Not Yet Recruiting

• 1 other identifier: DN-DLBS1033-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetic Neuropathy

Keywords

DLBS1033; Lumbricus rubellus; Nerve Conduction Study; Toronto Clinical Neuropathy Score; Interleukin-8; Galectin-3; Quality of Life; SF-36

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and week 12

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

DLBS1033 DIETARY_SUPPLEMENT

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

DLBS1033 Plus Standard Therapy

Placebo DIETARY_SUPPLEMENT

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

Placebo Plus Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RS H Adam Malik: lead

Study Sites (1)

RS H Adam Malik

Medan, North Sumatera, 20136, Indonesia

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

DLBS 1033

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Putri Gily De La Glory Ginting, Medical Doctor

  Department of Neurology, RS H Adam Malik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Putri Gily De La Glory Ginting, Medical Doctor

CONTACT

+6282276141617; putriginting99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)