Prospective on evaluation of use of , “AyurCoro3†as an add on medication for the treatment purpose in COVID-19 patients
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/10/028333
- Lead Sponsor
- Shri Sarveshwar Seva Sahkari Samstha
- Brief Summary
Prospective ,single center ,single blinded, randomized controlled study on evaluation of use of , “AyurCoro3â€as an adjuvant for the treatment purposein mild to moderate COVID-19 patients at tertiary care center.Studyprocedures shall be initiated post obtaining written informed consent process,as per local regulatory requirements. Randomization of the groups would be doneas per computer generated charts , details of the randomization are as perbelow mentioned chart. Randomizationchart is enclosed along with the protocol for reference .
Theparticipants were randomly allotted in the ratio 1:1 using a computer-generatedrandom-number list to either the ’Control Arm’ (‘Standard of Care’) orthe ’Intervention Arm’ (Study Medicineas an adjuvant to ’Standard of Care’). A total of 500 Patients would berandomized,250 in Control and 250 in Interventions. The participants wontnot incur any personal cost owing to the study .
Therandomization sequence with a size of 4 was generated by a statistician who wasnot part of the study team. Eligible patients are allocated to receivemedication, according to the sequential order. Envelopes are prepared foremergency unmasking. Laboratory technicians are blinded to treatmentallocation. The evaluators and statisticians are blinded until the completionof the visit and analysis. Data validation, cleaning and statistical analysisare done by trial researchers in collaboration with the Indian Institute ofTechnology Bombay (IIT Bombay), India. A Dedicated Research Coordinator who hadno involvement in the participant enrollment, would be doing the random allocation. ". After ensuring eligibilityof patients, a Dedicated Research Coordinator would communicate the assigned treatment to the recruiting investigator.
Study doctor will follow up telephonically 1 week postdischarge to enquire study participants about their health status for functional status scale -post covid-19 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
- Laboratory confirmed diagnosis of Mild to Moderate COVID-19 patients 2.
- Agree to consent for the study.
- All Age groups above 18 Years 4.
- All genders.
- 1.Patients on ventilator 2.Critically ill patient 3.Dyspnea, respiratory frequency ≥ 30/min, 4.Blood oxygen saturation (SpO2) ≤ 90%, 5.PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours 6.Patients with altered mental state 7.Patients with multiple organ failure requiring ICU monitoring and treatment.
- 8.Patients with respiratory failure and requiring mechanical ventilation/ 9.Patient who have participated in another investigational study within 3 months prior to enrollment in this study 10.Investigators, study personnel and their first-degree relatives.
- 11.Pregnant Patients 12.Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies).
- 13.Any other clinical reason which may preclude entry in the opinion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time (Days) to clinical improvement from study enrolment At Baseline, Day three , Day five and Day seven
- Secondary Outcome Measures
Name Time Method 1.Clinical status as assessed by the 9-point ordinal scale 2.Duration of hospitalization
Trial Locations
- Locations (1)
Bhaktivedanta Hospital and Research Institute
🇮🇳Thane, MAHARASHTRA, India
Bhaktivedanta Hospital and Research Institute🇮🇳Thane, MAHARASHTRA, IndiaDr Nanasaheb MemanePrincipal investigator8767271628drmemane@bhaktivedantahospital.com