Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome

Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome

Sponsoren

Hauptsponsor: China Medical University Hospital

Mitarbeiter: Chang Gung Memorial Hospital
China Medical University, China
National Research Program for Biopharmaceuticals, Taiwan

Quelle China Medical University Hospital
Kurze Zusammenfassung

To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.

detaillierte Beschreibung

Objective: To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.

Method:

The evidence of the regulation of oxidative-related cytokines and the antioxidant capacity could be provided from the previous randomized, double-blinded, placebo-controlled, cross-over design, two-center clinical trial for evaluating the effect of Chinese herbal medicine (SS-1) for the Sjögren's syndrome patients. However, the clinical trail could not find out the modulation of immunity-related gene expression for SS-1 treatment, and it did set up a healthy control group for SS-1 comparison. This study want to establish a healthy control group for evaluating the normal range of oxidative stress and cytokines, which this work could be used to compare with the 72 SS-1 subjects in previous study. And This study also want to analyze the 770 immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment: (1) The best 20 (at least) efficacy SJS subjects who were evaluated before and after SS-1 treatments. (2) The 10 (at least) healthy control subjects. The findings could provide the evidence on the modulation of immunity-related gene expression for clinical manifestation, oxidative stress and cytokine in Sjögren's syndrome patients.

Expected Results:

1. Establish the normal range of oxidative stress and cytokines for healthy control group.

2. To evaluate the regulatory effect on oxidative stress and cytokine secretion between SS-1 group and healthy control group.

3. To evaluate the immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment.

4. To evaluate the immunity-related gene expression among the best efficacy SJS subjects and healthy control subjects.

5. To evaluate the immunity-related gene expression with the characteristic of TCM tongue diagnosis.

6. To analyze the correlation among clinical manifestations, Sjögren's syndrome -related clinical questionnaires and immunity-related gene expression.

Gesamtstatus Unknown status
Anfangsdatum February 2014
Fertigstellungstermin April 2017
Primäres Abschlussdatum October 2016
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Ocular surface disease index (OSDI) 7 months
EULAR Sjogren's syndrome patient reported index (ESSPRI) 7 months
Sjogren's syndrome symptoms Questionnaire 7 months
Schirmer's test 7 months
Salivary scintigraphy 7 months
Sekundäres Ergebnis
Messen Zeitfenster
Oxidative stress and antioxidant capacity 7 months
Quality of life (SF-36) 7 months
Regulatory effect on cytokine 7 months
Nanostring nCounter immune Panel 7 months
Einschreibung 90
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: SS-1

Beschreibung: The patients will be divided into two groups (A and B) at random and all of them keep the routine treatment in the rheumatology OPD. Group A patients will receive 12 weeks SS-1 treatment first, and then stop the SS-1 for 4 weeks for wash-out phase, and then receive 12 weeks placebo treatment. Group B patients receive 12 weeks placebo first, and then stop the placebo treatment for 4 weeks for wash-out phase, and then receive 12 weeks SS-1 treatment. SS-1 is composed of 3 traditional Chinese herbal formula: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. The placebo is composed with corn starch, pigment and minimal dose of 1% SS-1. Patients in both groups take 6 gram of SS-1/Placebo three times per day.

Armgruppenetikett: SS-1

Anderer Name: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction

Interventionsart: Drug

Interventionsname: Placebo

Beschreibung: The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.

Armgruppenetikett: Placebo

Anderer Name: 1% SS-1

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Primary or Secondary Sjögren's syndrome patient

- Age from 20 to 75 year old, male or female patient

- Fit the criteria of 2002 year American-European classification

- If the subject took Cyclosporine, Cevimeline, Pilocarpine, Rituximab or other biological agent before enter into our study, the subject need to stop these drugs for one month

- If the subject took Gan-Lu-Yin, Sang- Ju-Yin or Xuefu-Zhuyu-Decoction before enter into our study, the subject need to stop these drugs for one month

- Secondary Sjögren's syndrome patient:

- Stable treatment: Steroid (≦10mg/d) and fixed hydroxychloroquine dose before 3 months enrolled

- No abnormal change of immunology, liver, kidney, and blood function

- No major life threatened condition

Exclusion Criteria:

- Alcohol abuse, DM (Glucose PC>200mg/dL) and major life threatened condition

- Pregnancy or breast feeding

- Abnormal liver and kidney function

- Forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the Chinese herbal medicine except SS-1

Geschlecht: All

Mindestalter: 20 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: Accepts Healthy Volunteers

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Hen-Hong Chang, M.D., Ph.D. Study Chair China Medical University Hospital
Gesamtkontakt

Nachname: Hen-Hong Chang, M.D., Ph.D.

Telefon: +886-3196200

Telefon ext.: 2677

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Ermittler:
Taoyuan Chang Gung Memorial Hospital | Gueishan Township, 333, Taiwan Recruiting Kuang-Hui Yu, M.D. [email protected] Shue-Fen Luo, M.D. Principal Investigator Jr-Rung Lin, Ph.D. Principal Investigator Yau-Huei Wei, Ph.D. Principal Investigator Ching-Mao Chang, M.D., Ph.D. Sub-Investigator Kuang-Hui Yu, M.D. Principal Investigator
China Medical University Hospital | Taichung, 404, Taiwan Recruiting Hen-Hong Chang, M.D., Ph.D. +886-4-22053366 3501 [email protected] Hen-Hong Chang, M.D., Ph.D. Principal Investigator
Standort Länder

Taiwan

Überprüfungsdatum

August 2016

Verantwortliche Partei

Art: Sponsor

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

Etikette: SS-1

Art: Experimental

Beschreibung: SS-1 is composed of the powder of Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. Patients take 6 gram of experiment medicine three times per day.

Etikette: Placebo

Art: Placebo Comparator

Beschreibung: The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.

Patientendaten Undecided
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Crossover Assignment

Hauptzweck: Treatment

Maskierung: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Quelle: ClinicalTrials.gov