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CTRI Number  CTRI/2020/05/025273 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On: 22/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Impact of effect of Ayurvedic treatment on novel Corona virus disease 
Scientific Title of Study   Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ganpat Devpura 
Designation  Professor Medicine 
Affiliation  National Institute of Medical Sciences 
Address  Professor Department of Medicine National Institute of Medical Sciences and Research, Jaipur India 303121
NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India
Jaipur
RAJASTHAN
303121
India 
Phone  9829069669  
Fax    
Email  gdevpura@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Sharma 
Designation  Assistant Professor Medicine 
Affiliation  National Institute of Medical Sciences 
Address  Professor Department of Medicine National Institute of Medical Sciences and Research, Jaipur India 303121
NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India
Jaipur
RAJASTHAN
302021
India 
Phone  9828816135  
Fax    
Email  dr.abhisheksharma1987@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Sharma 
Designation  Assistant Professor Medicine 
Affiliation  National Institute of Medical Sciences 
Address  Professor Department of Medicine National Institute of Medical Sciences and Research, Jaipur India 303121
NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India
Jaipur
RAJASTHAN
302021
India 
Phone  9828816135  
Fax    
Email  dr.abhisheksharma1987@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Research Institute Governed by Patanjali Reserach Foundation Trust, Haridwar, Uttrakhand 
 
Primary Sponsor  
Name  Patanjali Research Institute 
Address  Patanjali Research Institute Patanjali Yogpeeth Trust Haridwar, Uttarakhand 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
National Institute of Medical Sciences Jaipur  NH 11 C Jaipur Delhi Highway, Nims University Campus, Jaipur, Rajasthan, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepak Nathiya  National Institute of Medical Sciences  Department of Medicine, National Institute of Medical Sciences & Research, Nims University Rajasthan, Jaipur NH 11 C Jaipur Delhi Highway Nims University Campus, Jaipur, Rajasthan, India
Jaipur
RAJASTHAN 
9929600137

deepaknathiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurvedic Therapy  Tablet Pure Ashwagandha 500mg BD, Oral, After Breakfast / Dinner Tablet Pure Giloy Extract 1000 mg BD, Oral, after Breakfast / Dinner Tablet Pure Tulsi Extract 500 mg BD, Oral, after Breakfast/Dinner Anu Taila 4 drops BD, Nasal Drop Powder Swasari Ras 2 gm BD, Oral, Before Breakfast / Dinner 
Comparator Agent  Placebo Therapy  Placebo of same dosage form by Oral / Nasal route 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Asymptomatic patients
Mildly symptomatic patients
Moderately symptomatic patients
Age 15-80 years of age
Patients able to give Informed consent and follow instructions
Agree to follow at 14 days and 30 days after testing positive for COVID-19 
 
ExclusionCriteria 
Details  Severely symptomatic patients (SaO2 <90%)
Acute Respiratory Distress Syndrome (ARDS)
Life expectancy less than 1 year due to other co-morbid conditions 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Virological Clearance as measured by RT PCR of nasopharyngeal swab  Baseline, 3 Days, 7 Days, 14 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Conversion from Symptomatic to Asymptomatic patient

Reduction in C-reactive protein, ESR & IL-6

Improvement in heamatological parameters eg Total Leucocyte count

Safety analysis 
Baseline, 3 Days, 7 Days, 14 Days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/05/2020 
Date of Study Completion (India) 14/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Brief Summary  

COVID-19 infection is known to affect individuals with weak immunity more severely. Therefore, enhancing immunity is definitely one of the ways the doctors across the globe have been using for treating COVID-19 cases.

The study is Interventional Randomized parallel group placebo controlled, Single Centric trial in which Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) will be accessed.

To combat COVID-19 virus with Ayurveda, we have screened close to 1000 phytochemicals from more than 100 medicinal plants, in-sillico. We looked for their binding affinities to COVID-19 essential proteins and host protein interactions. We have discovered that natural phytochemicals in Ashwagandha, Giloy and Tulsi indeed have potentials to combat COVID-19 and its pathogenicity.

The patients who will be included in the study’s active control group will receive -

Tablet Swasari Ras                                       :             (500 mg)

Tablet Pure Ashwagandha Extract            :             (500 mg)

Tablet Pure Giloy Extract                           :             (500 mg)

Tablet Pure Tulsi Extract                            :             (500 mg)

Anu Taila (Nasal drop)

 

The above mentioned ayurvedic medicines will be used at following dosage :

In the morning:

At-least 60 mins before break-fast           :             4 drops of  Anu Taila (Nasal drop), in each nostril.

At-least 30 mins before break-fast           :             Swasari Ras 2 gm (with luke-warm water)          

At-least 30 mins after break-fast              :             2 Tablets Pure Giloy Extract

1 Tablet Pure Ashwagandha

1 Tablet Pure Tulsi Extract (with luke-warm water)

 

In the evening:

At-least 30 mins before dinner                 :             Swasari Ras 2 gm (with luke-warm water)

At-least 30 mins after dinner                    :             2 Tablets Pure Giloy Extract

                                                                 :             1 Tablet Pure Ashwagandha 

                                                                               1 Tablet Pure Tulsi Extract (with luke-warm water)

 

The above mentioned active control group will be compared with Placebo group receiving placebo of same dosage form. Symptomatic treatment will follow in both group along with treatment.

The primary outcome of the study will be assessed by measuring virological clearance as measured by RT PCR for nasopharageal swab at baseline, 3rdday, 7thdays and 14th day.

The secondary outcomes will be assessed by measuring conversion from symptomatic to asymptomatic patient, reduction in CRP protein, ESR & IL-6. Further improvement in hematological parameter, Total leucocyte count and lymphocyte count. Safety analysis will also be done.

 
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