A Clinical Study of Tranilast in the Treatment of Sarcoidosis

N

Nanjing Medical University

Status and phase

Unknown
Early Phase 1

Conditions

Sarcoidosis

Treatments

Drug: Tranilast

Study type

Interventional

Funder types

Other

Identifiers

NCT03528070
FirstNanjingMUMH Hou

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

56 participants in 1 patient group

Tranilast
Experimental group
Treatment:
Drug: Tranilast

Trial contacts and locations

0

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Central trial contact

Maihua Hou, professor

Data sourced from clinicaltrials.gov

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