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CTRI Number  CTRI/2020/08/027477 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 08/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Trial 
Public Title of Study   Evaluation of safety and efficacy of T-AYU-HM Premium and Onion steam vaporization/nebulization in Covid-19 patients. 
Scientific Title of Study   Evaluation of safety and efficacy of T-AYU-HM Premium and Onion Steam vaporisation/nebulization in Covid-19 patients (mild to moderate) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atul M Desai 
Designation  Proprietor 
Affiliation  Dhanvantari Clinic, Ayurveda health care and research center 
Address  Room no: 301, Ayurveda, Shreeji Desai market, Sardar Chowk Vyara-394650, Gujarat. India

Surat
GUJARAT
394650
India 
Phone  9879031621  
Fax    
Email  dratuldesai@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Atul M Desai 
Designation  Proprietor 
Affiliation  Dhanvantari Clinic, Ayurveda health care and research center 
Address  Room no: 301, Ayurveda, Shreeji Desai market, Sardar Chowk Vyara-394650, Gujarat. India

Surat
GUJARAT
394650
India 
Phone  9879031621  
Fax    
Email  dratuldesai@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hemshree Desai  
Designation  MD 
Affiliation  ATBU Harita Pharmaceuticals PVT LTD 
Address  ATBU Harita Pharmaceuticals Pvt ltd. Room No:110, Shreeji Desai Market Sardar Chowk Vyara

Surat
GUJARAT
394650
India 
Phone  9558054500  
Fax    
Email  hemshree94@gmail.com  
 
Source of Monetary or Material Support  
ATBU Harita Pharmaceuticals Pvt ltd. 110, Shreeji Desai Market, Sardar Chowk Vyara - 394650, Gujarat, India 
Dhanvantari Clinic, Ayurveda Health Care and Research Center 301, Shreeji Desai market, Sardar Chowk Vyara-394650, Gujarat. India  
 
Primary Sponsor  
Name  Dhanvantari Clinic Ayurveda Health Care and Research Center 
Address  Shreeji Desai Market, Vyara-394650, Gujarat. India  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
ATBU Harita Pharmaceuticals Pvt ltd  Vyara,Gujarat,India. Email: atbuharita@gmail.com 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Desai  Dhanvantari Clinic, Ayurveda Health Care and Research Center  Shreeji Desai Market, Vyara-394650, Gujarat. India
Surat
GUJARAT 
9879031621

dratuldesai@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DivyajyotiTrust  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Onion steam vaporization/nebulisation   Nasally OD for 21 days 
Intervention  Tablet T-AYU-HM Premium  600mg orally BD for 21 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age 18-80 years,
2. Both male and female
3. Mild to Moderate cases under home quarantine.
4. Willing to perform onion vaporization/nebulization
 once a day
5. Patients able to consume oral formulations.
6. Willing to provide informed consent.
 
 
ExclusionCriteria 
Details  1. Require mechanical ventilation
2. Unable to perform onion vaporization/nebulisation once a day.
3. Having serious stages illness
4. Pregnant/lactating women
5. Children below 18 years age
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Total number of participants with improvement in clinical symptoms – fever, Cough, Fatigue, Shortness of breath, Expectoration, Myalgia, Rhinorrhoea, Sore throat, Diarrhoea, Loss of smell (anosmia), Loss of taste (ageusia).
2. Total number of participants with resolution of clinical symptoms fever, Cough, Fatigue, Shortness of breath, Expectoration, Myalgia, Rhinorrhoea, Sore throat, Diarrhoea, Loss of smell (anosmia), Loss of taste (ageusia). 
21 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Oxygen requirement of patients
2. Improvement in oxygen saturation
3. Improvement in respiratory rate
4. Improvement in haematological parameters
5. Improvement in the level of other inflammatory markers CRP, ESR, LDH
 
Baseline
5th day
21th day
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
03/09/2020 
Date of Study Completion (India) 08/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Brief Summary
Modification(s)  

This study is a single arm, open label trial to evaluate the safety and efficacy of T-AYU-HM Premium 600 mg BD for 21 days and Onion steam vaporization/nebulization OD for 21 days in patients with COVID 19 that will be conducted at Dhanvantari Clinic, Ayurveda Health Care and Research Centre in India. The primary outcome measures will be improvement in clinical symptoms -  cough, fever with or without chills, difficulty in breathing, headache, sore throat and resolution of clinical symptoms by the end of the treatment. Secondary outcomes will be reduction in oxygen requirement of patients, improvement in oxygen saturation, improvement in respiratory rate, improvement in hematological parameters, improvement in the level of inflammatory markers.

 
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