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A Clinical Study of Tranilast in the Treatment of Mucinoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03490708
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
56 participants with Mucinoses will be selected to receive treatment of tranilast. After a period of time ,the investigators can determine the efficacy of the drug by detecting the the thickness and area of skin before and after treatment.

Condition or disease Intervention/treatment Phase
Mucinoses Drug: Tranilast Early Phase 1

Detailed Description:
56 participants with Mucinoses will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos,the thickness and area of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast (0.1g each time, three times a day,12 months) treatment, participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness and area. With 3 month as a time point, participants were observed for four points. After the experiment, the experimental data will be arranged and the data of the thickness and area change of skin lesions will be statistically processed to determine whether it is meaningful.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Tranilast in the Treatment of Mucinoses
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Tranilast
Subjects who were treated with tranilast
Drug: Tranilast
Subjects will be treated with tranilast

Primary Outcome Measures :
  1. Measure the volume change of skin lesions by ultrasound [ Time Frame: This experiment will last for 12 months ]
    During tranilast (0.1g each time, three times a day, 12 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Clinical and histopathological examination has been proved to be Mucinoses;
  2. Ultrasound and magnetic resonance detection found that the skin was thickened.

Exclusion Criteria:

  1. With a liver or kidney disease, or accompanied by a severe infection;
  2. Poor control of primary disease;
  3. With mental disease.

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University Identifier: NCT03490708    
Other Study ID Numbers: Mucinoses MH Hou
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Additional relevant MeSH terms:
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Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Platelet Aggregation Inhibitors
Anti-Allergic Agents