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CTRI Number  CTRI/2020/05/025370 [Registered on: 27/05/2020] Trial Registered Prospectively
Last Modified On: 25/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Trial 
Public Title of Study   Evaluation of Role of Ayurvedic Drug- Guduchi Ghan Vati in the treatment of COVID-19 related illness 
Scientific Title of Study   Evaluation of Efficacy and Safety of Ayurveda Intervention (Guduchi Ghan Vati) in the management of COVID-19 infection (Asymptomatic & Mild symptoms)- An open label single arm prospective clinical trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Abhimanyu Kumar 
Designation  Vice Chancellor 
Affiliation  Dr. S.R. Rajasthan Ayurved University, Jodhpur 
Address  Office of the Vice Chancellor, Room no- 101, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8800543828  
Fax    
Email  vc.dsrrau@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Abhimanyu Kumar 
Designation  Vice Chancellor 
Affiliation  Dr. S.R. Rajasthan Ayurved University, Jodhpur 
Address  Office of the Vice Chancellor, Room no- 101, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8800543828  
Fax    
Email  vc.dsrrau@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SANJAY SRIVASTAVA 
Designation  Assistant professor 
Affiliation  Dr. S.R. Rajasthan Ayurved University, Jodhpur 
Address  Department of Shalya Tantra, University College of Ayurveda, Room Number 162, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9414410383  
Fax    
Email  sanjayphyayu@gmail.com  
 
Source of Monetary or Material Support  
Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur 342037 
 
Primary Sponsor  
Name  Dr SR Rajasthan Ayurved University Jodhpur 
Address  Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur 342037 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr ABHIMANYU KUMAR  Covid care centre  Boranada Jodhpur
Jodhpur
RAJASTHAN 
8800543828

vc.dsrrau@gmail.com 
Prof Dr ABHIMANYU KUMAR  Covid care centre- University Hospital  University Hospital DSRRAU Jodhpur
Jodhpur
RAJASTHAN 
8800543828

vc.dsrrau@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC UCA DSRRAU Jodhpur  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 
Intervention  Guduchi Ghan Vati  Dose: 500mg- BD(Twice a day), Route of Administration- Oral, Duration- 30 days 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All hospitalized cases above 18-60 years of age, clinically diagnosed with corona virus disease 2019 (Covid19) and who are asymptomatic or having Mild symptoms.
2. Participants who can take medicines orally.
3. Patients willing to provide signed informed consent.
 
 
ExclusionCriteria 
Details  1. Cases of severe vomiting which would affect oral administration of medicine difficult.
2. Cases of respiratory failure and requiring mechanical ventilation.
3. Patients having Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper range of normal limits.
4. Patients with COVID-19 in critical condition or ARDS or NIAD 8 –point ordinal score-2 (Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation
5. Combined organ failure requiring ICU monitoring.
6. Patients with uncontrolled Diabetes Mellitus, (HbA1c more than 8.0), Malignant Hypertension (systolic BP more than 180 and diastolic 110), Chronic Renal Failure and those on immunosuppressive medication.
7. Patients with history of malignancy, IHD, CAD, triple vessel disease, history of CABG, Stroke, etc.
8. Any other condition, which as per the investigator would jeopardize the outcome of the trial.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Clinical cure rate: Time to get a negative status of Covid-19. (defined as viral load of respiratory specimen negative for two consecutive times when tested in an interval of two days) [Time frame 1 month]  [Time frame 1 month] 
 
Secondary Outcome  
Outcome  TimePoints 
1.Duration of fever and each of the respiratory symptoms
2.Improvement in hematological and laboratory parameters (lymphocyte count, Hs-CRP, ESR, TC,DC, Absolute lymphocyte count, LFT,RFT,IL-6, Ig E, Ig-G,Ig-M, LDH, Platelet count),
3.No of cases Reporting any ADR/AE
4.Number of patients referred.
5.Number of cases that required invasive or non-invasive oxygen therapy during the intervention.
6.Number of cases that progressed to multi- organ failure while under clinical trial.  
[Time Frame: 1 month]
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  
1. To assess the efficacy of Guduchi Ghan Vati in the patients of positive coronavirus Disease. (Laboratory confirmation + Patients with/ without uncomplicated respiratory tract infection which may have non-specific symptoms such as fever, fatigue, cough, anorexia, malaise, muscle pain, sore throat, dyspnoea, nasal congestion, or headache).


2.To assess the clinical safety of Guduchi Ghan Vati in the patients of positive coronavirus Disease.
 
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