A Clinical Study of Tranilast in the Treatment of Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

A Clinical Study of Tranilast in the Treatment of Sarcoidosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03528070
• Other study ID #: FirstNanjingMUMH Hou
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2018
• Est. completion date: December 2020

Study information

• Verified date: January 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Maihua Hou, professor
• Phone: +86 13776635881
• Email: houmaihua[@]jsph.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• Tranilast
Subjects will be treated with tranilast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the size of the pulmonary nodule by ultrasound	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.	12 months
Primary	Changes of the forced vital capacity(FVC)	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.	12 months