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CTRI Number  CTRI/2020/08/027009 [Registered on: 05/08/2020] Trial Registered Prospectively
Last Modified On: 25/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Use of Herbal Medicine like Tulasi,Amruth(Giloy), Turmeric,Ashwagandha for Improving the Immunity among Health care workers. 
Scientific Title of Study   A Clinical Study to Evaluate the role of Herbal Immunomodulators(sriveda sattva Pvt Ltd)in Boosting the Immunity among Health Care Workers assigned to COVID-19 Wards. 
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  DirectorcumDeanBMCRI 
Affiliation   
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  DirectorcumDeanBMCRI 
Affiliation   
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

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 III Floor, No. 54/46, 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 Pvt Ltd 54/56 39th A Cross 11th Main Road 4th TBlock 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 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
Bangalore
KARNATAKA 		 9448292424

bmccrj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BangaloreMedicalcollegeandResearchInstitute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health care workers working in Covid-19 wards 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Immunity Kit  a)Shakthi drops: 5 drops 3 times a day b)Amruth tablet: 1 tablet 2 times a day c)Turmeric Plus tablet:1 tablet 2 times a day d)TulsiArka: 10 drops 3 times a day  
Comparator Agent  will not receive anything  will not receive anything. will be control arm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants willing to give written informed consent.(Annexure 1)
2.Participants of either sex aged between 18 and 60 years.
3.Health care workers -Nurses
 
 
ExclusionCriteria 
Details  Participants who are not willing to give consent for the study.
2. Participants with comorbidities like Hypertension, Type 1 or 2 Diabetes mellitus,
3. Participants suffering from chronic conditions affecting any of the major organs such as, Liver, Kidney, heart and Lungs
4. Pregnant women/lactating mothers
5. Participants on immunosuppressants
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Measurement of serum levels of Anti-oxidant biomarkers such as Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH) at baseline (Day 0) and Day 15
2. Measurement of serum levels of Immune biomarkers such as IFN-β and
IFN- λ at baseline (Day 0) and Day 15
 		 Day 0 and Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measure:
1.Number and severity of side-effects if any.
 		 Day 15 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/08/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet finalised on the journal in which the data from the current study would be published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Ayurveda, one of the world known renowned forms of Indian traditional medicine, mentions several immunity enhancing herbs. Goal of Ayurveda has always been to enhance or restore health to the optimum in addition to cure the disease. Herbs are very powerful with ingredients that have unique properties which helps strengthen immune system and improve respiratory health.

The herbal immunomodulators (Sri Sri Tattva) immunity kit includes Shakthi drops, Amruth tablet, Turmeric Plus tablet and TulsiArka.

Health care workers receiving Herbal Immunomodulator immunity kit which includes,

a)      Shakthi drops: 5 drops 3 times a day

b)     Amruth tablet: 1 tablet 2 times a day

c)      Turmeric Plus tablet:1 tablet 2 times a day

d)     TulsiArka: 10 drops 3 times a day

Duration of treatment: 14 days.

Shakthi drops, a polyherbal formulation (Amla, Ashwagandha, Bhringaraj, Brahmi, Amruth, Shankapushpi, Shatavari, Yashtimadhu) possess immunomodulatory action, antioxidant property and helps to strengthen immunity.[1]

Amruth (Tinosporacordifolia) has immunomodulatory property, boosts immunity, acts as rejuvenating agent, eliminates toxins, destroys pathogens and combats various infections.[2]

In Turmeric Plus tablet (Curcumin+Piperine), Piperine (active component of Pepper) enhances absorption and bioavailabilty of curcumin by 2000 fold, thus creating Curcumin complex, whereas Curcumin (active component of Turmeric) is responsible for anti-inflammatory, anti-oxidant, antiseptic, anti-microbial properties. Curcumin-piperine combination significantly improves oxidative and inflammatory status.[3]

Tulsi Arka has potent antimicrobial and anti-oxidant properties. It has multiple therapeutic actions including anti-inflammatory, cardioprotective and immunomodulatory effects.[4]

Hence, the herbal modulators (Sri Sri Tattva) can be useful in combating the novel coronavirus through its anti-oxidant and immunomodulatory action.


Visit 1/ Day 0/ baseline assessment

Participant will be given a thorough explanation of the study and written informed consent will be obtained.

Participant will be enrolled as per inclusion/exclusion criteria.

Details of Participant’s demographic characteristics, medical histories, concomitant medications and detailed physical/clinical evaluation will be recorded.

 Blood sample will be collected for investigations - Anti-oxidant biomarkers [Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH)] and immune markers (IFN-β and IFN- γ)

 Medication will be issued along with instructions regarding its use to the    participant

Visit-2/ Day 7/ Follow-up 1:

Oropharyngeal swab will be done for the participants on 7th day of exposure or sooner if they develop influenza like illness for RT PCR (as per ICMR protocol) [5]

Visit-3/ Day 15/ Follow-up 2:

Anti-oxidant biomarkers [Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH)] and immune markers (IFN-β and IFN- γ) levels will be measured

Medication compliance, any intercurrent illness or change in concomitant medication will be recorded.

All observed or spontaneously volunteered side-effects will be recorded.

The study termination form will be completed.


 
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