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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:U071||COVID 19 virus identified. Ayurveda Condition: SANNIPATA-JVAROPADRAVAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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. |