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CTRI Number  CTRI/2020/04/024731 [Registered on: 20/04/2020] Trial Registered Prospectively
Last Modified On: 18/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Homeopathy 
Study Design  Single Arm Trial 
Public Title of Study   Study to Evaluate Preventive Effect of Ayurveda and Homeopathy Treatment in COVID 19  
Scientific Title of Study   Evaluation of Effect of Composite AYUSH Treatment as Prophylaxis 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 Hemant Toshikhane 
Designation  Dean and Principal 
Affiliation  Parul Institute of Ayurved 
Address  Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia,

Vadodara
GUJARAT
391760
India 
Phone  8469496525  
Fax    
Email  drhemantt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailesh Deshpande 
Designation  Professor, Kayachikitsa 
Affiliation  Parul Institute of Ayurved 
Address  Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia,

Vadodara
GUJARAT
391760
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harish Daga 
Designation  Lecturer, Shalya Tantra 
Affiliation  Parul Institute of Ayurved 
Address  Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia,

Vadodara
GUJARAT
391760
India 
Phone  9428563415  
Fax    
Email  ayurharish90@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved 
 
Primary Sponsor  
Name  Superintendent 
Address  Parul Ayurved Hospital, Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia, Vadodara, Gujarat 391760 
Type of Sponsor  Private medical college 
 
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 Hemant Toshikhane  Parul Ayurved Hospital  Ground Floor, Parul Ayurved Hospital, Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia,
Vadodara
GUJARAT 
8469496525

drhemantt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers who have high chances of exposure to COVID 19 patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Samshamani Vati (500 mg twice daily after food with warm water for 15 days), Sudarshan Ghana Vati (250 mg thrice daily after food with warm water for 15 days), Khadiradi Vati (250 mg twice daily for chewing for 15 days), Murrchhita Tila Taila (for Nasya (nasal instillation) 2 drops in each nostril in morning and evening for 15 days), Aesenic Album 30 (4 tablets before lunch for 3 days)   For 15 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects who are not suffering from active illness due to infecction at the time of inclusion 
 
ExclusionCriteria 
Details  1.Subjects suffering from active illness due to infection at the time of inclusion.
2.Subjects suffering from uncontrolled DM, HTN etc.
3. Subjects who are known cases of immune-compromised or autoimmune condition such as HIV.
4.Pregnant and lactating women  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19 during lockdown in March and April 2020  From Baseline till the end of 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of COVID 19 infection in study population  From Baseline till the end of 15 days 
Requirement of treatment for symptoms developed, if any, during study period  From Baseline till the end of 15 days 
Analysis of adverse events, if any  From Baseline till the end of 15 days 
 
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 
Date of First Enrollment (India)   24/04/2020 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Brief Summary   The COVID 19 outbreak has been declared as pandemic by the world health organisation. In view of lack of precise treatment or vaccine, the incidence and mortality due to the infection remain high and are very high. Ayurveda explains many medications and treatments in the management of febrile illnesses (Jwara) and diseases of respiratory system (Pranavaha Srotsa) which are being practised since many years and are proven effective. Hence it is high time to evaluate its effect as a preventive measure in symptoms of respiratory system infection seen in COVID 19 patients. Ayurveda explains many medications and treatments in the management of febrile illnesses (Jwara) and diseases of respiratory system (PranavahaSrotsa) which are being practised since many years and are proven effective. Hence it is high time to evaluate its effect as a preventive measure in symptoms of respiratory system infection seen in COVID 19 patients. Rasayana is the Rejuvenation branch of Ayurvedic medicine. Rasayana treatments were traditionally utilized after a period where the body was warn-down or depleted. Rasayana therapies are also used to remedy old age, before the term ‘anti-ageing’, there was Rasayana. Many classical formulations mentioned in Ayurvedic classic are excellent Rasayana medicines which can be used in treatment of various diseases including Jwara, Kasa, Kshaya. SamshamaniVati, KhadiradiVati, Dashmoola katutrayadi GhanVati are such medicines which can be useful in this condition. Nasya with AnuTaila in PratimarshaMatra (2 drops) is a remedy mentioned in Dinacharya that has shown beneficial effects in many URTI conditions. Arsenic album 30 a homeopathic medicine that is claimed to be beneficial in prevention from COVID 19 infection.  
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