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CTRI Number  CTRI/2020/07/026674 [Registered on: 19/07/2020] Trial Registered Prospectively
Last Modified On: 19/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ayurveda Spice Mix Tablet for the Prevention of COVID-19 infection in people exposed to Covid 19 and in high risk patients 
Scientific Title of Study   "Randomized Clinical Trial of Ayurveda Spice Mix Tablet for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel/High-Risk patients” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ghanashyam Marda 
Designation  Medical Officer-Principle Investigator 
Affiliation  Ashtang Ayurveda Mahavidyalaya 
Address  Ashtang Ayurveda Mahavidyala Hospital Kayachikitsa-Panchakarma Department 2062 sadashiv Peth Pune

Pune
MAHARASHTRA
411030
India 
Phone  9372009589  
Fax    
Email  drgmarda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ghanashyam Marda 
Designation  Medical Officer 
Affiliation  Ashtang Ayurveda Mahavidyalaya 
Address  Ashtang Ayurveda Mahavidyalaya Hospital Kayachikitsa-Panchakarma Department 2062 Sadshiv Peth Pune

Pune
MAHARASHTRA
411030
India 
Phone  9372009589  
Fax    
Email  drgmarda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manoj Chaudhari 
Designation  Vice principal- Co investigator 
Affiliation  Ashtang Ayurveda Mahavidyalaya 
Address  Ashtang Ayurveda Mahavidyalaya Samhita Department 2062 Sadashiv Peth Pune

Pune
MAHARASHTRA
411030
India 
Phone  8830239316  
Fax    
Email  drgmarda@gmail.com  
 
Source of Monetary or Material Support  
Ashtang Ayurveda Mahavidyalaya 2062 Sadashiv Peth Pune 411030 
Suraj Bio Herbal Pvt Ltd 102 Dixit Society Law College Road Erandwane Pune 411030 
 
Primary Sponsor  
Name  Suraj Ayurveda Clinic and Research center 
Address  102 dixit society law college road Erandwane Pune  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Suraj Bio Herbal Pvt ltd  102 dixit society law college road Erandwane Pune  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj Chaudhari Dr Ghanashyam Marda  Ashtang Ayurveda Mahavidyalaya  Ashtang Ayurveda Mahavidyala Hospital Kayachikitsa-Panchakarma Department 2062 sadashiv Peth Pune
Pune
MAHARASHTRA 
8830239316

manojsamhita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe Ashtang Ayurveda Mahavidyalaya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human exposed to COVID 19 or having Contact History and high risk patient group for Covid 19 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurveda Spice Mix tablet  Ayurveda Spice mix (Tulsimmune) 500 mg INGREDIENTS 1.Licorice-Glycerrhizaglabra – 50mg 2.Tulsi-Ocimum sanctum – 100 mg 3.Ginger – Zinzber officinalis 40 mg 4.Cinnamon – cinnamomum zylenicum 40 mg 5.black pepper – Piper nigrum 25 mg 6.Turmeric – Curcuma Longa 25 mg 7.Pippali - piper longum 40 mg 8.Amalaki – Phyllanthus emblica 80 mg 9. Guduchi – Tinospora cordifolia 100 mg The said formulation is FSSAI approved / and under approval of Fda  
Comparator Agent  Standard Prophylactic treatment used as per ICMR  HCQS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male or female aged 18-75 years
2. Health care workers/Covid Fighters like police/Social workers etc or high risk group patients in public/private hospitals in India or People in areas of risk of SARS-CoV-2 transmission.
3. People exposed to Covid 19 or having Contact history in 14 days
4. Understanding of the aim of the study and, therefore,acknowledging they have not been on any drug aiming atpre exposure prophylaxis against SARS-CoV-2 (COVID-19) since 1st of May 2020 untill 7 days before the study. This also includes drug forHIV.
5. Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause
 
 
ExclusionCriteria 
Details  1. COVID + Ve Patient with Symptoms of pneumonia/Hospitalized
2. Active hepatitis B infection, HIV infection
3. Renal failure with estimated glomerular filtration rate (GFR) < 60 ml/min) and patients on Hemodialysis.
4. Participant with any immunosuppressive condition or hematological disease
5. Breastfeeding
6. Known allergy to any of the medication used in this trial
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reducing number of infected patients in health professionals /workers, Covid fighters like police, social workers etc and people exposed Covid 19 or having history of Contact.   day 0, day 14, day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction in numbers of patients and duration of symptoms measured in days and severity of Symptoms of SARS-CoV-2 (COVID-19) confirmed infected participants of SARS-CoV-2 (COVID-19
2. Reduction in clinical severity of SARS CoV2 by SpO2%, Temperature, BP etc, Lab testing and Pulmonay Imaging if any
 
1. Reducing Duration of Symptoms in day 0, day 14, day 28
2. Change is Spo2%, Temp, BP, Lab testing and Pulmonary Imaging If anyday 0, day 14, day 28  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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 1 
Date of First Enrollment (India)   27/07/2020 
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="0"
Months="3"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

1. Title of the Research Project: "Randomized Clinical Trial of Ayurveda Spice Mix Tabetfor the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel/Covid Fighters/High-Risk patients”

2. Objectives:

Primary: Reducing the number of patients in Health workers/health professionals, Covid fighters like Police social worker and high risk patients in public/private hospitals in India or in areas of risk of SARS-CoV-2 transmission and PEOPLE EXPOSED to COVID 19 Or having CONTACT history

Secondary: Reduction in duration of symptoms measured in days and severity of Symptoms of SARS-CoV-2 (COVID-19) confirmed infected participants of SARS-CoV-2 (COVID-19in Covid Fighters/health care personnel and clinical severity COVID-19 among hospitals aged 18 to 75 years in public/private hospitals in India or in areas of risk of SARS-CoV-2 transmission and PEOPLE EXPOSED to COVID 19 or Having CONTACT history

3. Methodology

Inclusion Criteria-

1.  Male or female aged 18-75 years

2.  Health care workers/Covid Fighters like police/Social workers etc or high risk group patients in public/private hospitals in India or People in areas of risk of SARS-CoV-2 transmission.

3.  People exposed to Covid 19 or having Contact history in 14 days

4.  Understanding of the aim of the study and, therefore,acknowledging they have not been on any drug aiming atpre exposure prophylaxis against SARS-CoV-2 (COVID-19) since 1st of May 2020 untill 7 days before the study. This also includes drug forHIV.

5.  Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause.

Exclusion Criteria -

1.  COVID + Ve Patient with Symptoms of severe pneumonia/Hospitalised

2.  Active hepatitis B infection, HIV infection

3.  Renal failure with estimated glomerular filtration rate(GFR) < 60 ml/min) and patients on Hemodialysis.

4.  Participant with any immunosuppressive condition orhematological disease

5.  Breastfeeding

6.  Known allergy to any of the medication used in this trial

STUDY ARMS - Two

1.    Experimental – Ayurveda  spice mix therapy(Tulsi immune) with conventional treatment if taken already

2.    Standard control – Conventional Treatment HCQS+ Antiviral/azithromycin

STUDY DESIGN – Randomised controllede clinical trial

Randomisation – 1:1 After screening for inclusion

Allocation – computer generated numbers Concealment of allocation – central randomization

Sampling method – simple sampling method

Sample size 130 patients

Study sites – Ashtang Ayurved Mahavidyalaya- Rugnalaya, Pune Postal address: 2062, Sadashiv Peth, Late   Vd. H. B. Paranjpe Chouk, Vijayanagar Colony, Pune 411030

4.  Intervention and detailed posology

THE STUDY INTERVENTION PROCEDURE, The Aryurvedic therapy will be start at D0 to all SARS Cov2 health personnel /covid Fighter like police social workers/high risk patients who will continue their conventional treatment in experimental arm.

Conventional treatment patients taking is a standard control for this study.

·      Experimental - Ayurveda spice mix Tablet (Tulsimmune) with life style advise like Gargling, Nasal/chest oil Application and liquid dominant diet Intervention

1.Internal Intervention – Ayurveda Spice mix (Tulsimmune) tablet 500 mg three times a day with preferably chewing or with hot water/water

2.A special lifestyle regimen diet plan the person will follow which will include two substantial meals and one liquid meal, tea with spice like ginger, nasal chest application of Coconut oil with camphor in it.

Each Participant will receive  Ayurveda spice mix tablet (Tulsimmune) for 28 days

·      Standard Control – Conventional treatment-like HCQS +antival/azithromycin

5.  Assessment criteria

Primary Outcome measures

1.Reducing number of infected patients in health professionals /workers, Covid fighters like police, social workers etc.

Secondary Outcome Measures

1. Reduction in duration of symptoms measured in days and severity of Symptoms of SARS-CoV-2 (COVID-19) confirmed infected participants of SARS-CoV-2 (COVID-19

2. Reduction in clinical severity of SARS CoV2 by SpO2, Temp. Bp, Lab testing and Pulmonary Imaging If

6. Anticipated Outcome

Invention of Preventive prophylactic treatment for SARS Cov2 infection

7. Summary of the proposed research (up to 150 words ) indicating overall aims of the research, importance of the objectives and their application in the context of the priority areas set out in the application form.

Healthcare professionals/workers and covid fighters like police, social workers are particularly at risk of SARS-CoV-2. In the absence of a vaccine, other strategies aiming to reduce the development of COVID-19 in the population, more specificallyin healthcare workers is being sought. Administration ofeffective drugs to people at risk of developing an infectiousdisease is well accepted and is part of clinical practice. To date

there are some on-going randomized clinical trial on Preexposureprophylaxis evaluating chloroquine /hydroxychloroquine amd Antiviral drugs like Remdesivir efficacy for health care workers and othergroups of patients at high risk. Ayurveda, an ancient system of health and medicine described the epidemic or pandemic situation occurs due to contaminated air, water, seasons etc2 as well as touch of plant, human, animal etc. asa result ofthat human can suffer from fever, respiratory distress and degenerations Ayurveda says. This study aims to assess the efficacy of a daily Three dose ofAyurvedic spice mix tablet (Tulsimmune) with conventional treatment like HCQS antiviral/azithromycin as prophylaxis during 28 days: (1)reducing the incidence of symptomatic disease and (2)reducing clinical severity COVID-19 among healthcareworkers/professionals Covid fighters aged 18 to 65 years in public/private hospitals inIndia and High risk area of transmission. The spice Mixcontents are described in study design/appendix. The ingredients arehaving antiviral, immunomodulatory effects. Also they are supportingrespiratory system, reducing inflammation

8. Relevance and usefulness of the study with particular reference to concerned AYUSH system.

As there is no proven prophylactic preventative measures and Ayush system is known for preventative measures, this study will establish the role of Ayush system in prevention of novel diseases emerging in 20th century. It will establish the importance of usefulness of simple spices in food and Deencharya regimen in new diseases. It will also underlines the importance of Ancient knowledge system in todays perspective.

 
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