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CTRI Number  CTRI/2022/02/040562 [Registered on: 23/02/2022] Trial Registered Prospectively
Last Modified On: 21/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Ayurveda intervention as clinical trial against COVID-19  
Scientific Title of Study   Evaluating clinical efficacy of Guduchyadi compound in the management of Mild to Moderate COVID-19 cases along with comorbid conditions as stand alone and add on medicine. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Tanuja Manoj Nesari  
Designation  Director AIIA 
Affiliation  All India Institute of Ayurveda 
Address  All India Institute Of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 India

South
DELHI
110076
India 
Phone  8826167515  
Fax    
Email  tnesari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divya Kajaria 
Designation  Assistant professor, Department of Kayachikitsa 
Affiliation  All India Institute of Ayurveda 
Address  Room no 616, 6th floor Department of Kayachikitsa All India Institute Of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 India

South
DELHI
110076
India 
Phone  8826167515  
Fax    
Email  divyakajaria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasanth Dharmarajan 
Designation  Assistant professor, Department of Panchakarma 
Affiliation  All India Institute of Ayurveda 
Address  Room no 707,7th floor Department of Panchakarma All India Institute Of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 India

South
DELHI
110076
India 
Phone  9895174060  
Fax    
Email  drprasanthd@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda  
 
Primary Sponsor  
Name  All India Institute Of Ayurveda  
Address  All India Institute Of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
All India Institute Of Ayurveda    
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Divya kajaria  All India Institute Of Ayurveda   CHC,All India Institute Of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
South
DELHI 
8826167515

divyakajaria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The institutional ethics committee of All India Institute of Ayurveda, New DelhI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:U071||COVID 19 virus identified. Ayurveda Condition: SANNIPATA-JVAROPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Guduchyadi tablet, Reference: astanga hridaya jwara , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Newly diagnosed COVID-19 confirmed by RT-PCR.
2.Mild to Moderate COVID-19 infection.
3.Comorbid conditions (HTN, Diabetes, Metabolic
Syndrome)
4.Willingness and ability to comply with trial and follow-up
procedures.
5.Ability to understand the nature of this trial and give written informed consent. 
 
ExclusionCriteria 
Details  1.Patients with severe and critical infection will be excluded.
2.Patients with severe COVID-19 infection
3.Patients with respiratory failure who need mechanical ventilation
4.Patients who cannot take drug orally
5.Inability or unwillingness to comply with study and/or follow-up procedures
6.Enrolled in other researches for treatment of COVID-19 infection 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The proportion of the patients becoming RT – PCR Negative after being positive for covid-19  baseline (day 0) and after 7th day (day 8) and after 10 days (day 11) 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life (SF-36 proforma will be used)   30 days follow up after stopping ayurvedic medication 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/03/2022 
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="2"
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)?  

Response - NO
Brief Summary  
In the wake of COVID 19, an infectious disease caused by a newly discovered coronavirus,
entire mankind across the globe is suffering. Till date, no medicine or therapy has demonstrated
promising results in either preventing the disease or improving its prognosis to prevent this
infection.The intervention proposed under the project is a herbal combination based on traditional
knowledge of Ayurveda. The intervention is expected to improve quality of life of COVID
patients treated in addition to disease cure without major side effects.
 
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