CTRI Number	CTRI/2021/01/030795 [Registered on: 28/01/2021] Trial Registered Prospectively
Last Modified On:	31/07/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Modification(s)	Clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care.
Scientific Title of Study	A Single blind, randomized, placebo-controlled, exploratory clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care.
Secondary IDs if Any Modification(s)	Secondary ID  Registry  ICBio/CR/APPL/1311/117 Version 01 dated 13 Nov 2020  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  DrRahul Vilas Tulle  Address  Vedant Hospital, Medicinine Dpt Room no:04 Kasarwadavli Ghodbunder Road Thane (W) Maharashtra Mumbai (Suburban) MAHARASHTRA 400615 India  Phone  9823317762   Fax     Email  drrahul.tulle@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Harish S  Address  #16 & 18 ICBio Tower Yelahanka Main Road Chikkabettahalli Vidyaranyapura Bangalore KARNATAKA 560 097 India  Phone  9900111997   Fax     Email  harish@icbiocro.com
Details Contact Person Public Query Modification(s)	Name  Dr Harish S  Address  #16 & 18 ICBio Tower Yelahanka Main Road Chikkabettahalli Vidyaranyapura Bangalore KARNATAKA 560 097 India  Phone  9900111997   Fax     Email  harish@icbiocro.com
Source of Monetary or Material Support	Atrimed Pharmaceutical Pvt. Ltd. No. 29-30, Prestige Meridian, 14th floor, Tower 2, MG Road, Bengaluru-560001 Karnataka, India
Primary Sponsor	Name  Atrimed Pharmaceutical Pvt Ltd   Address  No. 29-30, Prestige Meridian, 14th floor, Tower 2, MG Road, Bengaluru-560001 Karnataka, India   Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 2   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Amol Laxmanrao Dange  Life point Multispeciality Hospital  145/1, Mumbai Bangalore Highway, Near Hotel Sayaji Wakad, Pune Pune   9823912040 amoldange298@gmail.com  DrRahul Vilas Tulle  Vedant Hospital   Medicine Dept, Room no:05 Kasarwadavli Ghodbunder Road Mumbai (Suburban)   9823317762 drrahul.tulle@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 2   Name of Committee  Approval Status  Lifepoint Research-Ethics committee  Approved  Vedant Hospital Ethics Committee Research Department  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  ATRICOV 452  ATRICOV 452 (500mg) 2 capsules TID for 14 days + standard of care   Comparator Agent  Placebo of ATRICOV 452   Placebo of ATRICOV 452 (500mg) 2 capsules TID for 14 days + standard of care
Inclusion Criteria	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  1.Both male and female adult populations aged from 18 to 60 years will be included in the study. 2.Confirmed RT-PCR positive for SARS CoV-2 and IgG –ve symptomatic patients as determined by the principal investigator/ Physician. 3.Controlled Diabetes (Type 2 DM (Hb1Ac < 7) and Hypertension (Systolic BP<140 mm Hg or diastolic BP<90 mm Hg). 4.Patient with BMI from ≥18 to ≤ 30 are included. 5.Patient is willing and able to comply with all trial requirements. All the patients obtained written informed consent form in English as well as native language, according to national regulations.
ExclusionCriteria	Details  1.If the physician finds vulnerability based on the history, nutritional status, physical appearance, or any other reason. 2.Judgment of the physician on likely need of ICU admission. 3.Known hepatic & kidney disease. 4.Known hypersensitivity to usual standard of care drug. 5.Known patient of cardiovascular disease, including congenital and ischemic heart disease, congestive cardiac failure. 6.Uncontrolled Type 2 DM (Hb1Ac >7), Insulin dependent DM & Uncontrolled HTN (systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg. 7.Patients with BMI <18 and > 30 (Obese) are not included in the study. 8.Hemoglobin < 8 gm/dl are excluded. 9.Known patient of HIV or on any other anti-viral medication for a disease other than Covid-19. 10.Pregnant and lactating women. 11.Presence of debilitating diseases like Tuberculosis, Rheumatoid arthritis, Carcinoma, Known case of inflammatory autoimmune diseases of any kind, neurodemyelinating diseases like Multiple sclerosis, Transverse myelitis, Thyroid, adrenal, pituitary endocrine disorders, Renal failure, Inflammatory bowel disease. 12.Patients who had participated in another clinical trial with in the previous 30 days. 13.Patients under immune suppressants and steroid (steroid for any other disease than Covid-19). 14.Signs and symptoms, haematological, imaging investigations show signs of severe COVID will be excluded. 15.Any other medical conditions that is considered as unsuitable for the study by investigator. 16.Patient is not willing to give inform consent form.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Investigator Blinded
Primary Outcome	Outcome  TimePoints  1.Time taken for clinical resolution of signs and symptom 2.Time taken for the conversion of COVID +ve to COVID -ve of throat swabs 3. Change in Disease progress markers  From screening to 14 days
Secondary Outcome	Outcome  TimePoints  1.Frequency of requirement for supplemental oxygen or non-invasive ventilation. 2.Frequency of requirement for mechanical ventilation. 3.Decrement of symptoms like headache, myalgia, rhinorrhea, loss of taste, loss of smell, diarrhoea, fatigue. 4.Number of people who needed ICU admission & number of days in ICU 5.Number of days in the hospital stay   From screening to 14 days
Target Sample Size	Total Sample Size="100" Sample Size from India="100"
Phase of Trial	Phase 2
Date of First Enrollment (India) Modification(s)	01/02/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="0" Days="23"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	NIL
Brief Summary Modification(s)	To evaluate the efficacy and safety of ATRICOV 452 in reduction of signs & symptoms of corona virus disease on patients diagnosed with SARS-Cov-2 (COVID-19) in comparison with placebo The treatment period is for 14 Days.  100 patients will be recruited for the clinical study. Patients will be randomized based on stratified randomization method . Diagnosis of SARS-CoV-2 infection will be made using RT­-PCR test .  The patients will be classified into mild, Moderate and severe