CTRI Number	CTRI/2020/05/025273 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On:	17/03/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	Impact of effect of Ayurvedic treatment on novel Corona virus disease
Scientific Title of Study	Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19)
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Ganpat Devpura  Address  Professor Department of Medicine National Institute of Medical Sciences and Research, Jaipur India 303121 NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India Jaipur RAJASTHAN 303121 India  Phone  9829069669   Fax     Email  gdevpura@yahoo.co.in
Details Contact Person Scientific Query Modification(s)	Name  Dr Abhishek Sharma  Address  Professor Department of Medicine National Institute of Medical Sciences and Research, Jaipur India 303121 NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India Jaipur RAJASTHAN 302021 India  Phone  9828816135   Fax     Email  dr.abhisheksharma1987@gmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Abhishek Sharma  Address  Professor Department of Medicine National Institute of Medical Sciences and Research, Jaipur India 303121 NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India Jaipur RAJASTHAN 302021 India  Phone  9828816135   Fax     Email  dr.abhisheksharma1987@gmail.com
Source of Monetary or Material Support Modification(s)	Patanjali Research Institute Governed by Patanjali Reserach Foundation Trust, Haridwar, Uttrakhand
Primary Sponsor	Name  Patanjali Research Institute  Address  Patanjali Research Institute Patanjali Yogpeeth Trust Haridwar, Uttarakhand  Type of Sponsor  Research institution
Details of Secondary Sponsor	Name  Address  National Institute of Medical Sciences Jaipur  NH 11 C Jaipur Delhi Highway, Nims University Campus, Jaipur, Rajasthan, India
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Deepak Nathiya  National Institute of Medical Sciences  Department of Medicine, National Institute of Medical Sciences & Research, Nims University Rajasthan, Jaipur NH 11 C Jaipur Delhi Highway Nims University Campus, Jaipur, Rajasthan, India Jaipur   9929600137 deepaknathiya@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Respiratory failure, unspecified
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Ayurvedic Therapy  Tablet Pure Ashwagandha 500mg BD, Oral, After Breakfast / Dinner Tablet Pure Giloy Extract 1000 mg BD, Oral, after Breakfast / Dinner Tablet Pure Tulsi Extract 500 mg BD, Oral, after Breakfast/Dinner Anu Taila 4 drops BD, Nasal Drop Powder Swasari Ras 2 gm BD, Oral, Before Breakfast / Dinner  Comparator Agent  Placebo Therapy  Placebo of same dosage form by Oral / Nasal route
Inclusion Criteria	Age From  15.00 Year(s) Age To  80.00 Year(s) Gender  Both  Details  Asymptomatic patients Mildly symptomatic patients Moderately symptomatic patients Age 15-80 years of age Patients able to give Informed consent and follow instructions Agree to follow at 14 days and 30 days after testing positive for COVID-19
ExclusionCriteria	Details  Severely symptomatic patients (SaO2 <90%) Acute Respiratory Distress Syndrome (ARDS) Life expectancy less than 1 year due to other co-morbid conditions
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment
Blinding/Masking
Primary Outcome	Outcome  TimePoints  Virological Clearance as measured by RT PCR of nasopharyngeal swab  Baseline, 3 Days, 7 Days, 14 Days
Secondary Outcome	Outcome  TimePoints  Conversion from Symptomatic to Asymptomatic patient Reduction in C-reactive protein, ESR & IL-6 Improvement in heamatological parameters eg Total Leucocyte count Safety analysis  Baseline, 3 Days, 7 Days, 14 Days
Target Sample Size	Total Sample Size="120" Sample Size from India="120"
Phase of Trial	N/A
Date of First Enrollment (India)	29/05/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="2" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Phytomedicine Volume 84 April 2021 153494
Brief Summary Modification(s)	COVID-19 infection is known to affect individuals with weak immunity more severely. Therefore, enhancing immunity is definitely one of the ways the doctors across the globe have been using for treating COVID-19 cases. The study is Interventional Randomized parallel group placebo controlled, Single Centric trial in which Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) will be accessed. To combat COVID-19 virus with Ayurveda, we have screened close to 1000 phytochemicals from more than 100 medicinal plants, in-sillico. We looked for their binding affinities to COVID-19 essential proteins and host protein interactions. We have discovered that natural phytochemicals in Ashwagandha, Giloy and Tulsi indeed have potentials to combat COVID-19 and its pathogenicity. The patients who will be included in the study’s active control group will receive - Tablet Swasari Ras                                       :             (500 mg) Tablet Pure Ashwagandha Extract            :             (500 mg) Tablet Pure Giloy Extract                           :             (500 mg) Tablet Pure Tulsi Extract                            :             (500 mg) Anu Taila (Nasal drop)   The above mentioned ayurvedic medicines will be used at following dosage : In the morning: At-least 60 mins before break-fast           :             4 drops of  Anu Taila (Nasal drop), in each nostril. At-least 30 mins before break-fast           :             Swasari Ras 2 gm (with luke-warm water)           At-least 30 mins after break-fast              :             2 Tablets Pure Giloy Extract 1 Tablet Pure Ashwagandha 1 Tablet Pure Tulsi Extract (with luke-warm water)   In the evening: At-least 30 mins before dinner                 :             Swasari Ras 2 gm (with luke-warm water) At-least 30 mins after dinner                    :             2 Tablets Pure Giloy Extract                                                                  :             1 Tablet Pure Ashwagandha                                                                                 1 Tablet Pure Tulsi Extract (with luke-warm water)   The above mentioned active control group will be compared with Placebo group receiving placebo of same dosage form. Symptomatic treatment will follow in both group along with treatment. The primary outcome of the study will be assessed by measuring virological clearance as measured by RT PCR for nasopharageal swab at baseline, 3rdday, 7thdays and 14th day. The secondary outcomes will be assessed by measuring conversion from symptomatic to asymptomatic patient, reduction in CRP protein, ESR & IL-6. Further improvement in hematological parameter, Total leucocyte count and lymphocyte count. Safety analysis will also be done.