A Clinical Study of Tranilast in the Treatment of Sarcoidosis

Early Phase 1

• Conditions: Sarcoidosis
• Interventions: Drug: Tranilast

• Registration Number: NCT03528070
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-04-19
• Study Start: 2018-05
• Study First Submitted QC: 2018-05-06
• Last Update Submitted: 2018-05-06
• Study First Posted: 2018-05-17
• Last Update Posted: 2018-05-17
• Primary Completion: 2020-05
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranilast	Tranilast	-

Primary Outcome Measures

Name	Time	Method
Changes of the forced vital capacity(FVC)	12 months	During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the forced vital capacity(FVC),then get the changes.
Changes in the size of the pulmonary nodule by ultrasound	12 months	During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the size of the pulmonary nodule by ultrasound. The investigators can get the changes in the size of the pulmonary nodule.