DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy
ConditionDiabetic Neuropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRS H Adam Malik
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DLBS1033
Dietary supplementDLBS1033 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.
Placebo
Dietary supplementParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: DLBS1033 Plus Standard TherapyExperimental treatment 1 intervention
Group B: Placebo Plus Standard TherapyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 122
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 123
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 12Secondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: