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CTRI Number  CTRI/2020/07/026371 [Registered on: 05/07/2020] Trial Registered Prospectively
Last Modified On: 05/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Kabasura Kudineer, Shakti drops and Turmeric plus in the management of COVID-19 
Scientific Title of Study   A clinical study to evaluate the effect of AYUSH medicines in the management of 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 Ranganatha R 
Designation  Consultant and HeadPulmonology, Mazumder Shaw Medical Centre 
Affiliation  Narayana Hrudayalaya, Bangalore 
Address  Department of Pulmonology Room No 31 Mazumdar Shaw Medical Centre Unit of Narayana Hrudayalaya, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9740200774  
Fax    
Email  rrpulmo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranganatha R  
Designation  Consultant and HeadPulmonology, Mazumder Shaw Medical Centre 
Affiliation  Mazumder Shaw Medical Centre Narayana Hrudayalaya, Bangalore 
Address  Department of Pulmonology Room No 31 Mazumdar Shaw Medical Centre Narayana Hrudayalaya, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone    
Fax    
Email  rrpulmo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Ravi Kumar Reddy 
Designation  Chief Scientific Officer 
Affiliation  Sri Sri Tattva 
Address  Research and Development Block , Room No 1 Sriveda Sattva Pvt Ltd 54/56 39th A Cross 11th Main Road 4th T Block Jayanagar Bangalore Karnataka India 560041 Bangalore KARNATAKA

Bangalore
KARNATAKA
560041
India 
Phone  09346857001  
Fax    
Email  dr.ravireddy@srisritattva.com  
 
Source of Monetary or Material Support  
Sriveda Sattva Private Limited -Sri Sri Tattva 54/56 39th A Cross 11th Main Road 4th T Block Jayanagar Bangalore Karnataka India 560041 
 
Primary Sponsor  
Name  Sriveda Sattva Private Limited Sri Sri Tattva 
Address  Sriveda Sattva PvtLtd 54/56 39th A Cross11th Main Road 4th T Block Jayanagar Bangalore Karnataka India 560041 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Ranganath R  Mazumder Shaw Medical Centre Narayana Hrudayalaya, Bangalore  258/A, Bommasandra Industrial Area, Hosur Road , Anekal Taluk , Bangalore, Karnataka - 560099
Bangalore
KARNATAKA 
9740200774

rrpulmo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Medical Ethics Committee  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  1.Kabasura kudineer 2.Shakti Drops 3.Turmeric plus tablets  1.Kabasura kudineer 2 tablets taken thrice a day before food 2.Shakti Drops – 6 drops with 100 ml of water thrice a day before food 3.Turmeric plus tablets – 2 tablets thrice a day after food 
Comparator Agent  only ongoing allopathic medicines   only ongoing allopathic medicines 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age limit – 20 to 55 years, both Male &Female
2. Uncomplicated cases of COVID19 patients on Allopathic medication of stage 1 and stage 2
3. Patients whom ventilator support is not required
4. Patients with no associated comorbidities
5.patientswillingtogivetheirconsenttoparticipateintheclinicaltrial 
 
ExclusionCriteria 
Details  1. COVID-19 positive patients above 55 years of age & below 20years
2. Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or chronic or acute renal failure or pre -existing cardiac conditions.
3. Patients on immuno-suppression therapy
4. Pregnant Women or lactating mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Early recovery in the signs and symptoms of cases of stage 1 and stage 2 of COVID-19 by adding Ayurvedic medicines which are effective in fever, symptoms of respiratory tract and by enhancing immunity of body by adding Rasayana drugs  1,14,21 and 28 the day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement of quality life of cases of stage 1 and stage 2 of COVID-19  1 and 28 th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   13/07/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary
Modification(s)  
COVID -19 is an illness caused due to novel corona virus 2, now called as Severe Acute Respiratory Syndrome Corona Virus -2 (SARS CoV 2). It was first reported from Wuhan City, China. It was declared as a pandemic by WHO on March11,2020, as ith as confirmed its presence in all continents except Antarctica [1].
Ayurveda has unique methods of approaching a newly detected disease. Rather than focusing on the microbiological etiology, Ayurveda embraces a holistic technique for elaborating the details of the disease at hand, with a three pointed approach in the elaboration of an unknown disease-the natural history of the disease (VikaraPrakriti), the site of the pathological process (Adhishtanam/Srotasa) and etiological features (SamuthaanaVisesham)[2]
Study design: Multi centric, open labelled, randomised controlled trial
Site name: Department of Pulmonology, Mazumdar Shaw Medical Centre, Narayana Hrudayalaya, Bangalore
Study duration:
Period required for pre-trial preparation: three months (Including drug preparations) Period which may be needed for collecting the data: one year Period that may be required for analyzing the data: Three months (3 months)
No of groups: 2 groups
Group A-trial group- Ayurveda treatment with ongoing allopathic medicines
Group B- Standard control group–only on going allopathic medicines
“Patients who are included in the standard care will be given an option for taking AYUSH medicines (Kabasura Kudineer tablets, Shakti drops, Turmeric tablets) at the end of 14 days irrespective of the RTPCR status or continue in the standard care. If the participant is interested, the medications will be dispensed for 21 days and will be followed up till end of intervention. If the participant continues in the standard care the trial period and follow up will remain unchanged.”
Inclusion criteria
Age limit – 20 to 55 years, both Male &Female
Uncomplicated cases of COVID19 patients on Allopathic medication of stage 1 and stage 2
Patients whom ventilator support is not required
Patients with no associated comorbidities
Patients willing to give their consent to participate in the clinical trial
Exclusion criteria
COVID-19 positive patients above 55 years of age & below 20 years
Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or 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, Pre Existing Cardiac condition, organ failure.
Procedure
The study will be initiated after Institute ethics committee approval and the study will be registered in Clinical Trial registry of India. Clinical study will be carried out in adult cases of stage1 and stage2 of COVID-19 who are undergoing standard allopathic treatment. The patients presenting with signs and symptoms of stage 1 and stage 2 of COVID-19, attending the hospital and fulfilling the criteria of diagnosis and inclusion criteria, willing to give their consent to participate in the clinical trial will be registered. These registered patients will be then randomly divided by computer generated randomization sequence in group A and group B. Each registered patient will be provided the details of clinical trial by patient information sheet and after taking their consent, detailed history will be taken as per clinical research Performa and generated data will be used for research.
Group A: In this, along with ongoing allopathic medicines below mentioned Ayurveda treatment will be given to Patients presenting with stage 1 symptoms of COVID -19 like Sore throat/ congestion in throat, fever, slight cough, nasal congestion, malaise and headache
Kabasura kudineer 2 tablet taken thrice a day before food
Shakti Drops – 6 drops with 100 ml of water thrice a day before food
Patients presenting with stage 2 of COVID-19 like dry cough, breathlessness, pain and discomfort in the chest with fever. In addition to Kabasura Kudineer Tablets and Shakti Drops as mentioned in stage 1,
Turmeric plus tablets – 2 tablets thrice a day after food
Along with this, ongoing allopathic medicines will be allowed. Along with this, patients will be advised dietary and life style modifications. For this, patients will be asked to take freshly prepared easily digestible, light diet and to avoid using sweets and food which is heavy to digest, chilled, fried, oily, fermented food items, cold and refrigerated food /beverages.
Group B- Standard control group – only ongoing allopathic medicines.
“Patients who are included in the standard care will be given an option for taking AYUSH medicines (Kabasura Kudineer tablets, Shakti drops, Turmeric tablets) at the end of 14 days irrespective of the RTPCR status or continue in the standard care. If the participant is interested, the medications will be dispensed for 21 days and will be followed up till end of intervention. If the participant continues in the standard care the trial period and follow up will remain unchanged.”
Total duration of the therapy: 21 days
Follow up: for 28 days
Primary and secondary endpoint
Early recovery in the signs and symptoms of cases of stage 1 and stage 2 of COVID-19 by adding Ayurvedic medicines which are effective in fever, symptoms of respiratory tract and by enhancing immunity of body by adding Rasayana drugs
Improvement of quality life of cases of stage 1 and stage 2 of COVID-19


 
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