A Clinical Study of Tranilast in the Treatment of Sarcoidosis

NCT ID: NCT03528070

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Sarcoidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tranilast

Group Type EXPERIMENTAL

Tranilast

Intervention Type DRUG

Subjects will be treated with tranilast

Interventions

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Tranilast

Subjects will be treated with tranilast

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Maihua Hou, professor

Role: CONTACT

+86 13776635881

Other Identifiers

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FirstNanjingMUMH Hou

Identifier Type: -

Identifier Source: org_study_id

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