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/2021/03/032385 |
|
Full text link
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54420 |
|
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) |
drneerajk@aiimspatna.org |
|
Registration date
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2021-03-30 |
|
Recruitment status
Last imported at : May 27, 2021, 12:45 a.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 : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
|
Center
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
single-center |
|
Study aim
Last imported at : May 27, 2021, 12:45 a.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) |
RT PCR proved COVID-19 positive patients admitted in AIIMS Patna <br/ >Age â?¥ 18 years < 70 years <br/ > |
|
Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1. Patients with severe CAD <br/ >2. Congestive heart failure(CHF) <br/ >3. Stage II hypertension <br/ >4. Hypotension <br/ >5. Patients on insulin, Diabetic Neuropathy, <br/ >6. Diabetic Keto acidosis <br/ >7. Stroke and peripheral arterial disorder <br/ >8. Pre-existing Cardiovascular disease <br/ >9. Recent MI <br/ >10. Cardiac transplant within the last 12 months <br/ >11. Pregnancy <br/ >12. Patient with peripheral Edema <br/ >13. Patient with Cardiac Arrhythmia <br/ > |
|
Number of arms
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
4 |
|
Funding
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
AIIMS Patna |
|
Inclusion age min
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
|
Inclusion age max
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
70 |
|
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 : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
No restriction on type of patients |
|
Severity scale
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
0: No restriction on type of patients |
|
Total sample size
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
160 |
|
primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
To study and compare efficacy of: <br/ >1.Vitamin D3 with Magnesium Glycinate therapy. <br/ >2.Cilnidipine + Telmisartan therapy. <br/ >3.Vitamin D3 + Magnesium Glycinate + Cilnidipine + Telmisartan therapy. <br/ >for reduction in severity of COVID-19 disease using non-invasive measurement of Arterial Stiffness as a clinical marker <br/ >Timepoint: The Pulse wave velocity in both groups will be evaluated on Day 1; 3; 5 and at discharge or day 7 or on the day of clinical deterioration whichever is earlier. |
|
Notes
Last imported at : May 27, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
|
Phase
Last imported at : May 27, 2021, 12:45 a.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": "(1) Pulse wave velocity between 279-364 cm/sec (Arterial stiffness level) \nvs (2) Pulse wave velocity between 364-580 cm/sec (Arterial stiffness level) ", "treatment_id": 1466, "treatment_name": "Cilnidipine+telmisartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "(1) Pulse wave velocity between 279-364 cm/sec (Arterial stiffness level) \nvs (2) Pulse wave velocity between 364-580 cm/sec (Arterial stiffness level) ", "treatment_id": 2221, "treatment_name": "Magnesium sulfate+vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "(1) Pulse wave velocity between 279-364 cm/sec (Arterial stiffness level) \nvs (2) Pulse wave velocity between 364-580 cm/sec (Arterial stiffness level) ", "treatment_id": 2223, "treatment_name": "Cilnidipine+magnesium sulfate+telmisartan+vitamin d", "treatment_type": "Cardiovascular agents+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |