A Clinical Study of Tranilast in the Treatment of Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03528070
• Date of registration: 19/04/2018
• Prospective Registration: Yes
• Primary sponsor: The First Affiliated Hospital with Nanjing Medical University
• Public title: A Clinical Study of Tranilast in the Treatment of Sarcoidosis
• Scientific title: A Clinical Study of Tranilast in the Treatment of Sarcoidosis
• Date of first enrolment: May 2018
• Target sample size: 56
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03528070
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Early Phase 1

Contacts

• Name: Maihua Hou, professor

Key inclusion & exclusion criteria

Inclusion Criteria:

- (1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic
granuloma and negative staining of fungi and atypical mycobacterium; (2)No
corticosteroids and immunosuppressants were used for nearly 1 months.

Exclusion Criteria:

- 1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ;
(2)with mental disease.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: Tranilast

Primary Outcome(s)

Changes in the size of the pulmonary nodule by ultrasound [Time Frame: 12 months]

Changes of the forced vital capacity(FVC) [Time Frame: 12 months]

Secondary ID(s)

FirstNanjingMUMH Hou

Source(s) of Monetary Support

Please refer to primary and secondary sponsors