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Column | Value |
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Trial registration number | IRCT20170128032241N3 |
Full text link
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
info@sbmu.ac.ir |
Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2020-08-17 |
Recruitment status
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
Study design
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
Allocation
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
Design
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
Masking
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
Center
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
single-center |
Study aim
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Treatment |
Inclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Virological diagnosis of SARS-CoV-2 infection by RT-PCR Positive imaging findings: Condensation, Grand Glass opacity or bilateral pulmonary infiltration on CT scan or Chest X-ray Need to get extra oxygen to maintain SO2> 94% or PaO2 / FiO2> 300 |
Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Age less than 18 years The patient has septic shock Pregnancy and lactation The patient is intubated and under mechanical ventilation The patient was admitted to the ICU Having an allergy to curcumin |
Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2 |
Funding
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Shahid Beheshti University of Medical Sciences |
Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
100 |
Countries
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
Type of patients
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
20 |
primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
1- Evaluation of clinical variables involved in patients' recovery including mechanical ventilation 2- Organ failure and comparison of these results in the two groups of treatment and control 3- Mortality and comparison of these results in the two groups of treatment and control 4- The length of hospital stay and comparison of these results in the treatment and controlgroups 5- Length of ICU hospitalization and comparison of these results in the treatment and controlgroups 6- Receiving oxygen and comparing these results in the treatment and control groups 7- The length of the negative period of PCR test and comparison of these results in thetreatment and control groups 8- Comparison of interleukin-6 levels in the treatment and control groups 9- Comparison of patients' ferritin levels in treatment and control groups 10- Comparison of patients' CRP levels in treatment and control groups 11- Length of improvement period of patients' lung imaging results and comparison of results intreatment and control groups 12- Lymphocyte count and comparison of results in treatment and control groups 13- Length of respiratory symptoms and comparison of results between treatment and controlgroups |
Notes
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Phase
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 3 |
Arms
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "", "treatment_id": 362, "treatment_name": "Curcumin", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |