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CTRI Number  CTRI/2020/07/026756 [Registered on: 23/07/2020] Trial Registered Prospectively
Last Modified On: 22/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda strength and immunity enhancing protocol and immunity in health care workers : Clinical trial of an Ayurveda Intervention  
Scientific Title of Study   Evaluation of the efficacy of Ayurveda drugs for enhancing overall strength and immunity in health care workers of All India Institute Of Ayurveda - An exploratory clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanuja Manoj Nesari  
Designation  Director  
Affiliation  All India Institute Of Ayurveda 
Address  Director , Academic Building , Ground Floor ,All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar , New Delhi
Department of Dravya guna , 2nd Floor , Academic Building , All India Institute Of Ayurveda , New Delhi
South West
DELHI
110076
India 
Phone  9958817145  
Fax    
Email  director@aiia.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Kumar Bhatted  
Designation  Associate Professor  
Affiliation  All India Institute Of Ayurveda 
Address  Department of Panchakarma , 7th Floor , Academic Building , All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar ,New Delhi
All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar ,New Delhi
South West
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Kumar Bhatted  
Designation  Associate Professor  
Affiliation  All India Institute Of Ayurveda 
Address  Department of Panchakarma , 7th Floor , Academic Building , All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar ,New Delhi
All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar ,New Delhi
South West
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda , New Delhi  
 
Primary Sponsor  
Name  All India Institute Of Ayurveda  
Address  All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar ,New Delhi ,110076  
Type of Sponsor  Research institution and hospital 
 
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 Santosh Kumar Bhatted   All India Institute Of Ayurveda  All India Institute Of Ayurveda , Mathura Road , Gautampuri ,Sarita vihar ,New Delhi
South West
DELHI 		 9414048459

santoshbhatted@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All healthy human volunteers of both sex between age group of 19-60 years.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1)Tab Shanshamni Vati 2)Ayush Kadha 3)Chyavanprash 4)Anu Taila 5)Gargle with warm water mixed with rock salt and turmeric 6)Ayush Preventive guidelines for COVID 19 with Yoga and Pranayama All above treatment will be given for 60 days with a Follow up period of 60 days   1) Tab Shanshamni Vati 250 mg 2 bid after food with warm water 2) AYUSH Kadha 40ml bd empty stomach 3)Chyavanprash 3gms in morning once a day 4)Application Of Anu Taila 2 drops in each nostril once a day after bath in morning 5) Gargle with warm water mixed with rock salt and turmeric 6) AYUSH preventive guidelines for COVID 19 with Yoga and Pranayama All above treatment will be given for 60 days with a Follow up period of 60 days  
Comparator Agent  Not Applicable   Not Applicable  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either sex aged 19-60 years
2. Only willing staff of AIIA having risk of exposure to COVID-19 infection.
3. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals.
4. Individuals agree to give consent for participation
 
 
ExclusionCriteria 
Details  1. Individuals with chronic comorbid conditions which has affected the Bala of the Individual.
2. Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results
3. Individuals found positive for COVID 19 during the course of medication. Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19
4. Previously diagnosed with COVID-19
5. Subjects on other prophylactic medications.
6. Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Improvement in Bala of an individual
2 Immuno-stimulation leading to non-development of symptoms of COVID- 19 in risk population working in Hospital set up.
 
4 Assessments at a gap of 30 days
Baseline 0
Assessment 1
Assessment 2
Assessment 3
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life   4 Assessment at a gap of 30 days
Baseline 0
Assessment 1
Assessment 2
Assessment 3  
 
Target Sample Size   Total Sample Size="425"
Sample Size from India="425" 
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   N/A 
Date of First Enrollment (India)   28/07/2020 
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="4"
Days="0" 
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  

Research Hypothesis:

 

Standalone therapy with Ayurveda medicine as per AYUSH protocol/guidelines in an individual’s having risk of exposure to COVID-19 will help in preventing the infection by improving Bala (overall strength and Immunity) of the individual.

 

Null Hypothesis:

There is no significant changes in Bala (overall strength and Immunity), including quality of life of an individual having risk of exposure to COVID infection, hence unable to prevent COVID infection after Ayurveda Intervention.

Alternate Hypothesis:

There is significant changes in Bala (overall strength and Immunity), including quality of life of an individual having risk of exposure to COVID infection, hence able to prevent COVID infection after Ayurveda Intervention.

Aim

The aim of this exploratory study is to explore the efficacy of Ayurveda intervention as per AYUSH protocol in preventing the COVID-19 infection to an individual’s having risk of exposure to COVID-19 infection.

Objective:

·         Primary objective - To explore the efficacy of an Ayuveda intervention, in terms of improving Bala (overall strength and Immunity), in turn may help in preventing COVID-19 infection.

·         Secondary objective – Improvement in Quality of Life (QoL)

Methodology

Health care workers of AIIA, having risk of exposure to COVID-19 infection (n=425) will be administered with Ayurveda intervention along with the preventive measures as advised by AYUSH ministry and conventional prevention measures for COVID-19 infection. Individuals will be enrolled for the study after taking the written informed consent from all participants. This study will be subjected for approval by the institutional ethics committee of AIIA. Participants will be observed for a period of 120 days for any Changes in Deha bala (physical strength), Agni bala (digestion and metabolism) and Chetasa Bala (psychological strength), patient reported outcomes, Quality of Life, incidence of infection with COVID-19. Also the appearance of respiratory and other symptoms of COVID-19, and ADR’s if any.

Research Design: Interventional study Duration of Intervention: 60 Days Follow up: 60 Days

Total Duration of trial: 120 Days

Intervention- Ayurveda intervention along with following preventive guidelines of both AYUSH and conventional medicine- A single arm study

 

 

Inclusion criteria:

1.        Patients of either sex aged 19-60 years

2.        Only willing staff of AIIA having risk of exposure to COVID-19 infection.

3.      Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals.

4.        Individuals agree to give consent for participation

 

Exclusion criteria:

1.                 Individuals with chronic comorbid conditions which has affected the Bala of the Individual.

2.                 Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results

3.                 Individuals found positive for COVID 19 during the course of medication. Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19

4.                 Previously diagnosed with COVID-19

5.                 Subjects on other prophylactic medications.

6.                 Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.

Investigations: The following investigations will be done before starting the intervention in order to assess any underlying condition and after completion of intervention to assess the overall effect of intervention on the body apart from subjective assessment.

Hb, TC, DC, ESR, SGOT, Blood urea, Lipid profile, IGG and IGM

Intervention: (for 60 days)

1.        Tab Samshamani Vati 250 mg 2 bid after food with warm water

2.        AYUSH Kadha 40 ml BD empty stomach

3.        Chyavanprash 03 GMS in the morning once a day

4.        Application of Anu taila 2 drops in each nostril once a day after bath in the morning

5.        Gargle with warm water mixed with rock salt and turmeric

6.        AYUSH preventive guidelines for COVID 19 with Yoga and Pranayama

 

During follow up: (For 60 days)

1.        Only observation with routing preventive measures as mentioned above.

2.        Individuals will be assessed intermittently at 30 days of period and follow up will be done for 60 days after completion of the intervention.

Mechanism of Action of Intervention

Above drugs have been chosen as they play a significant role in enhancing the strength and immunity of the individual. Sanshamani Vati has Guduchi (Amrita), as main content, which is a drug described under Vayah Sthapana Mahakashaya (C.S. Su-4/18) Rasayan (Bha. Pr.), Anu taila performs the action of local barrier to the entry of virus through the portal of nose, besides strengthening the mucosal barrier of the respiratory system and nourishing other tissues. Chyavanprasha is one of the time tested Ayurveda formulation used since ancient time to enhance the strength and immunity in general and of the respiratory and cardio vascular system in particular, Amalaki being the main ingredient of Chyavanprasha known for its higher concentration of Vitamin C which is considered as the best molecule in the prevention and management of Covid-19 infection. Ingredients of AYUSH kadha (decoction) are known for antimicrobial action in general and enhances the digestion and metabolism which indirectly plays a significant role in the maintenance of healthy immune system and overall strength of the individual. Ayurveda believes in the principle of Kshetra (Host) that is strengthening of the body so that the seed of the disease may find it infertile to grow and flourish. Strengthening the body tissues is providing the Yuktikrita bala (Acquired Immunity) to the individual so that the disease may either not flourish at all or even if it manifests, it may produce the disease in a very mild form with less discomfort to the body and results in early healing.

Drugs used in this study are as per the protocol mentioned by Ministry of AYUSH, Govt. of India. Drugs used are intended to improve the Bala (strength and immunity) of an individual to fight against the infection in turn preventing COVID-19 infection.

Guduchi has been studied and found to have immunomodulation activity, anti-inflammatory, anti- arthritic, anti-pyretic, anti-infective, anti-osteoporotic, anti-allergic, anti-oxidant, anti-neoplastic, radio-protective, hepatoprotective, anti-hyperglycemic, cardio-protective activity. [13]

Anu taila (Ashtanga Hr.Sutra sthana-20/37-38) if applied in the nostrils, it acts as barrier for entry of virus. Anu taila Nasya has only few scientific studies till now, there is no study focused on its immunity boosting and nourishing effects etc. [17],

Hence, knowing the efficacy of Ayurveda drugs to improve the overall strength and provide healthy immune system in health care workers which may prevent them from acquiring Covid-19 infection.

Rescue Medication – If the patient complains of any new complain or any existing disease worsens, then rescue medication as needed will be given to the patients in the supervision of the respective experts and it will be recorded in the study along with their dose and duration. The Ayurveda intervention will be continued after the resolution of the symptoms.

Adverse events – Adverse events if any developed during the usage of the intervention will be recorded.

Restrictions - The patients will be advised to strictly follow the dietary guidelines regarding food, food habits and life style advised to them by Ministry of AYUSH. “Ayurveda’s immunity boosting measures for self-care during COVID 19 crisis”

Withdrawal of the Patient –

If the patient develops any adverse reaction or doesn’t want to continue with the study

Follow up

The patient’s will be assessed intermittently at 30 days of period and follow up will be done one month after completion of the trial.

Criteria for assessment

·         The subjective wellbeing of the individuals will be assessed.

·         Bala assessment of an individual will be done by assessing the Deha bala by Vyayama Shakti (capacity to do the physical activity including exercise), Agni bala by Abhyavaharana and Jarana Shakti (Digestive capacity), Chetasa bala by self-assessment questionnaire

·         To assess the effect objectively Specific lab investigations like IGG and IGM for immunity, SGOT for liver metabolism, Lipid profile for lipid metabolism, Blood urea for functioning of kidney, Hb% and TC, DC, ESR to assess status of any infection.

·         Assessment of Quality of Life by using WHO SF-36 questionnaire

·         The percentage of susceptible individuals developing infection of COVID-19

Source of data:

literature both Ayurveda and Contemporary Science

Health care workers working at All India institute of Ayurveda New Delhi.

Statistical Data Analysis

Suitable Statistical analysis will be done.

Outcomes of Study

 

Primary

 

 

 

 

·         Improvement in Bala of an individual

·         Immuno-stimulation leading to non-development of symptoms of COVID- 19 in risk population working in Hospital set up.

 

 Secondary

·         Overall Improvement in Quality of Life

 

Previous research work

As COVID-19 is a recent infection outbreak, no researches have been done on the efficacy of Ayurveda interventions in health care workers. To the best of our knowledge, this is the first study of its kind.

Purpose -

Any positive leads found in this study will provide breakthrough knowledge in stopping the epidemic of COVID-19 infections and decrease the morbidity and mortality related to the disease.


 
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