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DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy

27 giugno 2026 aggiornato da: Putri Gily De La Glory Ginting, RS H Adam Malik

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Putri Gily De La Glory Ginting, Medical Doctor
  • Numero di telefono: +6282276141617
  • Email: putriginting99@gmail.com

Luoghi di studio

  • Indonesia
    • North Sumatera
      • Medan, North Sumatera, Indonesia, 20136
        • RS H Adam Malik
        • Contatto:
        • Investigatore principale:
          • Putri Gily De La Glory Ginting, Medical Doctor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: DLBS1033 Plus Standard Therapy
Participants in this arm will receive DLBS1033 as adjunctive therapy in addition to standard therapy for diabetic neuropathy for 12 weeks.
Integratore alimentare: DLBS1033
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.
Altri nomi:
  • Lumbricus rubellus Extract
Comparatore placebo: Placebo Plus Standard Therapy
Participants in this arm will receive placebo in addition to standard therapy for diabetic neuropathy for 12 weeks.
Integratore alimentare: Placebo
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.
Altri nomi:
  • Capsula placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at Week 12
Lasso di tempo: 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.
Baseline and week 12
Change From Baseline in Distal Latency Assessed by Nerve Conduction Study at Week 12
Lasso di tempo: 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.
Baseline and week 12
Change From Baseline in Nerve Response Amplitude Assessed by Nerve Conduction Study at Week 12
Lasso di tempo: 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.
Baseline and week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Toronto Clinical Neuropathy Score During 12 Weeks
Lasso di tempo: Baseline, week 4, week 8, and week 12
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.
Baseline, week 4, week 8, and week 12
Change From Baseline in Serum Interleukin-8 Level at Week 12
Lasso di tempo: Baseline and 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.
Baseline and week 12
Change From Baseline in Serum Galectin-3 Level at Week 12
Lasso di tempo: Baseline and 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.
Baseline and week 12
Change From Baseline in Short Form-36 Quality of Life Score During 12 Weeks
Lasso di tempo: Baseline, week 4, week 8, and week 12
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.
Baseline, week 4, week 8, and week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

RS H Adam Malik

Investigatori

  • Investigatore principale: Putri Gily De La Glory Ginting, Medical Doctor, Department of Neurology, RS H Adam Malik

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DN-DLBS1033-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the data contain confidential patient information and there is no current plan for public data sharing.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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