A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

Sponsoren

Hauptsponsor: Chung Shan Medical University

Quelle Chung Shan Medical University
Kurze Zusammenfassung

To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.

detaillierte Beschreibung

This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.

Gesamtstatus Completed
Anfangsdatum May 6, 2016
Fertigstellungstermin December 31, 2017
Primäres Abschlussdatum October 31, 2017
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12 week 0, week 12
Sekundäres Ergebnis
Messen Zeitfenster
Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4 week 0, week 4
Physicians Global Assessment to measure quality of life (PGA) week 0, week 4, week 8, week 12
Visual Analog Scale for pain (VAS) week 0, week 4, week 8, week 12
Quality of life by SF-36 week 0, week 4, week 8, week 12
modified fatigue impact scale (MFI) week 0, week 4, week 8, week 12
Pittsburgh Sleep Quality Index (PSQI) week 0, week 4, week 8, week 12
Body Constitution Questionnaire (BCQ) week 0, week 4, week 8, week 12
Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8 week 0, week 8
Einschreibung 30
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: TCM (Gan-Lu-Yin)GLY

Beschreibung: TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks

Armgruppenetikett: TCM Gan-Lu-Yin (GLY)

Anderer Name: Gan-Lu-Yin

Interventionsart: Drug

Interventionsname: PLACEBO

Beschreibung: TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Armgruppenetikett: PLACEBO

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Age ≥20 years old

- Written informed consent obtained

- Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)

- The ESSPRI score of the patient of Sjogren's syndrome at least> 3

Exclusion Criteria:

- Have association disease about heart, lung, nerve or mental

- Pregnant or breastfeeding women

- Laboratory abnormality:

1. Serum creatinine ≥2.0 mg/dl

2. Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl

3. Neutrophil or lymphocyte<0.5 x 109/l

Geschlecht: All

Mindestalter: 20 Years

Maximales Alter: 80 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Wei C- C, M Principal Investigator Chung Shan Medical University
Ort
Einrichtung: Chung Shan Medical University Hospital
Standort Länder

Taiwan

Überprüfungsdatum

September 2019

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Chung Shan Medical University

Vollständiger Name des Ermittlers: Cheng-Chung Wei

Ermittlertitel: Professor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: TCM Gan-Lu-Yin (GLY)

Art: Experimental

Beschreibung: TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks

Etikette: PLACEBO

Art: Placebo Comparator

Beschreibung: TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Basic Science

Maskierung: Triple (Participant, Care Provider, Investigator)

Quelle: ClinicalTrials.gov