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CTRI Number  CTRI/2020/06/025592 [Registered on: 04/06/2020] Trial Registered Prospectively
Last Modified On: 03/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Trial 
Public Title of Study   Use of Herbal Medicine likeTulasi,Amruth(Giloy), Turmeric,Ashwagandha as add on treatment in COVID-19 Patients 
Scientific Title of Study   A clinical Study to Evaluate the Role of Herbal Immunomodulators as add on Treatment in Asymptomatic and Mildly Symptomatic COVID-19 Confirmed Cases. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr C R Jayanthi 
Designation  Director cum Dean BMCRI 
Affiliation  Bangalore Medical College research Institute 
Address  Bangalore Medical College research Institute Fort KR Road Bengaluru Department of COVID-19, Division - Isolation ward Room number - 1

Bangalore
KARNATAKA
560002
India 
Phone  9448292424  
Fax    
Email  bmccrj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr C R Jayanthi 
Designation  Director cum Dean BMCRI 
Affiliation  Bangalore Medical College research Institute 
Address  Bangalore Medical College research Institute Fort KR Road Bengaluru Department of COVID-19, Division - Isolation ward Room number - 1

Bangalore
KARNATAKA
560002
India 
Phone  9448292424  
Fax    
Email  bmccrj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Ravi Kumar Reddy 
Designation  Chief Scientific Officer 
Affiliation  Sri Sri Tattva 
Address  Sriveda Sattva Pvt Ltd 54/56 39th A Cross 11th Main Road 4th TBlock Jayanagar Bangalore Karnataka India 560041

Bangalore
KARNATAKA
560041
India 
Phone  9346857001  
Fax    
Email  dr.ravireddy@srisritattva.com  
 
Source of Monetary or Material Support  
Sriveda Sattva PvtLtd 54/56 39th A Cross 11th Main Road 4th T Block Jayanagar Bangalore Karnataka India 560041 
 
Primary Sponsor  
Name  Sri Sri Tattva 
Address  Sriveda Sattva PvtLtd 54/56 39th A Cross11th Main Road 4th T BlockJayanagarBangaloreKarnatakaIndia560041 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr C R Jayanthi  Bangalore Medical college and research institute  Department of COVID-19, Division - Isolation ward Room number - 1 Fort KR road, Bangalore
Bangalore
KARNATAKA 
9448292424

bmccrj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical college and research institute  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  Immunity Kit  Shakti drops: Dosage: 5 drops 3 times a day (Morning/ Afternoon/Night) Amruth tablet: Dosage: 1 tablet 2 times a day Turmeric plus tablet:: Dosage: 1 tablet 2 times a day Tulsi arka: Dosage: 10 drops 3 times a day (Morning/ Afternoon/Night) 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Confirmed Asymptomatic and mildly symptomatic cases of COVID-19 infection by laboratory tests
Age limit 18 to 60 years both Male and Female
Uncomplicated cases of COVID - 19 patients on Allopathic medication
Patients in whom ventilator support is not required
Patients with no associated co morbidities
Patients willing to give informed consent to participate in the clinical trial  
 
ExclusionCriteria 
Details  COVID-19 positive patients above 60 years of age & below 18 years with Symptoms.
Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes mellitus, chronic or acute renal failure
Patients on Immuno-suppression therapy
Pregnant Women or lactating mothers Patients in advanced stage of disease requiring emergency medical intervention like pneumonia, bronchial asthma, organ failure
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Early recovery in the signs and symptoms of cases of Asymptomatic and mild symptomatic COVID-19 patients by adding Ayurvedic medicines which are effective in enhancing immunity of body and reducing the symptoms such as Fever and respiratory distress   Day 1 and Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
a. TNF-α
b. IL-6
c. IFN- β
d. IFN-λ 
Day 1 and Day 30 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   13/06/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet finalised on the journal in which the data from the current study would be published. 
Brief Summary  

Title: A clinical Study to Evaluate the role Herbal Immunomodulators as add on Treatment in Asymptomatic and Mildly Symptomatic COVID-19 Confirmed Cases.

This open Label,  Comparative Interventional  study,conducted among 50 asymptomatic and mildly symptomatic COVID-19 confirmed patients  using Ayurveda Drugs :
SHAKTI DROPS: Dosage:  5 drops 3 times a day (Morning/ Afternoon/Night)

AMRUTH TABLET: Dosage:  1 tablet 2 times a day

TURMERIC PLUS TABLET: Dosage:  1 tablet 2 times a day

TULSI ARKA: Dosage:  10 drops 3 times a day (Morning/Afternoon/ Night)

Inclusion Criteria: Confirmed Asymptomatic and mildly symptomatic cases of COVID-19 infection by laboratory tests 

Age limit 18 to 60 years both Male and Female

Uncomplicated cases of COVID - 19 patients on Allopathic medication 

Exclusion Criteria: 

COVID-19 positive patients above 60 years of age & below 18 years with Symptoms.

Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes mellitus, chronic or acute renal failure

Patients on Immuno-suppression therapy

Pregnant Women or lactating mothers Patients in advanced stage of disease requiring emergency medical intervention like pneumonia, bronchial asthma, organ failure


Site: Bangalore Medical college and research institute
Primary Outcome: Early recovery in the signs and symptoms of cases of Asymptomatic and mild symptomatic COVID-19 patients by   adding Ayurvedic medicines which are effective in enhancing  immunity of body and reducing the symptoms such as Fever and respiratory distress  on Day 1 and Day 30
Seconadry Outcome:TNF-α, IL-6, IFN- β, IFN-λ  on Day 1 and Day 30
 
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