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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01245036 |
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Date of registration:
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15/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Antituberculous Therapy in Management of Sarcoidosis
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Scientific title:
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Rifampicin and Isoniazid Along With Prednisolone Compared to Prednisolone Alone in Treatment of Sarcoidosis: a Pilot Randomized Controlled Trial |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01245036 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dheeraj Gupta |
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Address:
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Telephone:
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Email:
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Affiliation:
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PGIMER, Chandigarh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
newly diagnosed sarcoidosis defined by presence of all of the following criteria:
1. Presence with clinical features of pulmonary (dyspnea, dry cough, chest pain, fever,
fatigue or crackles) or extra pulmonary organ (lymph nodes, liver, spleen, skin,
eyes, heart, etc.) involvement and consistent radiological involvement and
2. Compact non-caseating granulomas on trans-bronchial biopsy which are tissue AFB
smear-negative
Exclusion Criteria:
Patients who have received glucocorticoid treatment before initial evaluation by us, or
with presence of concomitant other cardio pulmonary disease will be excluded.
Age minimum:
15 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sarcoidosis
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Tuberculosis
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Intervention(s)
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Drug: Antituberculous therapy along with steroids
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Primary Outcome(s)
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Remission rates
[Time Frame: Three months]
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Secondary Outcome(s)
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Treatment related adverse effects in the two groups.
[Time Frame: Through out]
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Relapse rates in the two groups
[Time Frame: six and 12 months after completion of treatment]
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Secondary ID(s)
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Sarc/Att/01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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