NCT03528070

A Clinical Study of Tranilast in the Treatment of Sarcoidosis

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

56 patients with sarcoidosis will be selected to receive treatment of tranilast.The investigators can analyse the changes in the thickness and area of skin lesions before and after treatment as well as other involved organs nodule size changes to determine the efficacy and safety of drugs.

Detailed description

56 patients with sarcoidosis will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos, the size of the lump by ultrasound, the forced vital capacity(FVC), and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast treatment (0.1g each time, three times a day) , participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, every three months to retest ultrasound and the forced vital capacity(FVC). With 3 month as a time point, participants were observed for four points(one point if only skin invasion ).After the experiment, the experimental data will be arranged and the data will be statistically processed (t test) to determine whether it is meaningful.

Conditions

• Sarcoidosis

Interventions

Type	Name	Description
DRUG	Tranilast	Subjects will be treated with tranilast

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-05-01
• Completion: 2020-12-01
• First posted: 2018-05-17
• Last updated: 2018-05-17