v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
Column | Value |
---|---|
Trial registration number | CTRI/2020/09/027687 |
Full text link
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47280 |
First author
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
Contact
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
shobha_bhushan@yahoo.co.in |
Registration date
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2020-09-09 |
Recruitment status
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not recruiting |
Study design
Last imported at : Nov. 18, 2021, 7:33 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : Nov. 18, 2021, 7:33 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
Center
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
single-center |
Study aim
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
I. All patients with age more than 18 years who are asymptomatic,mild cases of COVID-19 who are under home isolation <br/ >II. COVID-19 positive cases under home isolation who consents for the study <br/ >III. Household contacts of home isolated COVID-19 patients who are able to understand and follow/perform the interventions. <br/ > |
Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
i. Patients with known history of immuno-suppressive disorders <br/ >ii. Patients with known history of hyperthyroidism and other thyroid diseases and with symptoms suggestive of thyroid dysfunction like tremors, palpitation, heat/cold intolerance, lethargy, menstrual irregularities etc <br/ >iii. Pregnant and lactating women <br/ >iv. Patients with nasal polyps, recurrent nasal bleeding <br/ >v. Patients with known allergy to iodine and its compounds and on Lithium therapy <br/ > |
Number of arms
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
8 |
Funding
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Dr Shobha |
Inclusion age min
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
Inclusion age max
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
100 |
Countries
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
India |
Type of patients
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Mild disease at enrollment |
Severity scale
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1: Mild disease at enrollment |
Total sample size
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
80 |
primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1) Reduction in severity of symptoms (VAS; temperature etc) in mild cases <br/ >2) Early negativity of the RT PCR in nasopharyngeal swab among the intervention group when compared to the controls <br/ >3) Reduction in transmission of infection among household members of COVID-19 patient <br/ >Timepoint: 1) Baseline assessment and daily follow up of symptoms till 21 days <br/ >2) Baseline swab test and swab test once every 3 days till two successive tests are negative <br/ >3) Baseline symptomatic assessment of contacts and daily follow up of evolution of symptoms till 21 days and one swab test between 5th to 10th days of contact to assess transmission pattern. <br/ > |
Notes
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
Phase
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not reported |
Arms
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "", "treatment_id": 1238, "treatment_name": "Steam", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1238, "treatment_name": "Steam", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1142, "treatment_name": "Saline gargling", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1142, "treatment_name": "Saline gargling", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |