A Clinical Study of Tranilast in the Treatment of Sarcoidosis

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03528070

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis	Drug: Tranilast	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Clinical Study of Tranilast in the Treatment of Sarcoidosis

Anticipated Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tranilast	Drug: Tranilast Subjects will be treated with tranilast

Arm

Intervention/Treatment

Experimental: Tranilast

Drug: Tranilast

Subjects will be treated with tranilast

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.