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DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy

27. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Indonesien
    • North Sumatera
      • Medan, North Sumatera, Indonesien, 20136
        • RS H Adam Malik
        • Kontakt:
        • Hauptermittler:
          • Putri Gily De La Glory Ginting, Medical Doctor

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Nahrungsergänzungsmittel: 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.
Andere Namen:
  • Lumbricus rubellus Extract
Placebo-Komparator: Placebo Plus Standard Therapy
Participants in this arm will receive placebo in addition to standard therapy for diabetic neuropathy for 12 weeks.
Nahrungsergänzungsmittel: 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.
Andere Namen:
  • Placebo-Kapsel

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Nerve Conduction Velocity Assessed by Nerve Conduction Study at Week 12
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Toronto Clinical Neuropathy Score During 12 Weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

RS H Adam Malik

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. Februar 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DN-DLBS1033-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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