| CTRI Number |
CTRI/2020/05/025370 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
25/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Role of Ayurvedic Drug- Guduchi Ghan Vati in the treatment of COVID-19 related illness |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Ayurveda Intervention (Guduchi Ghan Vati) in the management of COVID-19 infection (Asymptomatic & Mild symptoms)- An open label single arm prospective clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Abhimanyu Kumar |
| Designation |
Vice Chancellor |
| Affiliation |
Dr. S.R. Rajasthan Ayurved University, Jodhpur |
| Address |
Office of the Vice Chancellor, Room no- 101, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8800543828 |
| Fax |
|
| Email |
vc.dsrrau@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Abhimanyu Kumar |
| Designation |
Vice Chancellor |
| Affiliation |
Dr. S.R. Rajasthan Ayurved University, Jodhpur |
| Address |
Office of the Vice Chancellor, Room no- 101, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8800543828 |
| Fax |
|
| Email |
vc.dsrrau@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY SRIVASTAVA |
| Designation |
Assistant professor |
| Affiliation |
Dr. S.R. Rajasthan Ayurved University, Jodhpur |
| Address |
Department of Shalya Tantra, University College of Ayurveda, Room Number 162, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur 342037 |
|
|
Primary Sponsor
|
| Name |
Dr SR Rajasthan Ayurved University Jodhpur |
| Address |
Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur 342037 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr ABHIMANYU KUMAR |
Covid care centre |
Boranada
Jodhpur
Jodhpur
RAJASTHAN |
8800543828
vc.dsrrau@gmail.com |
| Prof Dr ABHIMANYU KUMAR |
Covid care centre- University Hospital |
University Hospital
DSRRAU Jodhpur
Jodhpur
RAJASTHAN |
8800543828
vc.dsrrau@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC UCA DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi Ghan Vati |
Dose: 500mg- BD(Twice a day),
Route of Administration- Oral,
Duration- 30 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All hospitalized cases above 18-60 years of age, clinically diagnosed with corona virus disease 2019 (Covid19) and who are asymptomatic or having Mild symptoms.
2. Participants who can take medicines orally.
3. Patients willing to provide signed informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Cases of severe vomiting which would affect oral administration of medicine difficult.
2. Cases of respiratory failure and requiring mechanical ventilation.
3. Patients having Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper range of normal limits.
4. Patients with COVID-19 in critical condition or ARDS or NIAD 8 –point ordinal score-2 (Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation
5. Combined organ failure requiring ICU monitoring.
6. Patients with uncontrolled Diabetes Mellitus, (HbA1c more than 8.0), Malignant Hypertension (systolic BP more than 180 and diastolic 110), Chronic Renal Failure and those on immunosuppressive medication.
7. Patients with history of malignancy, IHD, CAD, triple vessel disease, history of CABG, Stroke, etc.
8. Any other condition, which as per the investigator would jeopardize the outcome of the trial.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Clinical cure rate: Time to get a negative status of Covid-19. (defined as viral load of respiratory specimen negative for two consecutive times when tested in an interval of two days) [Time frame 1 month] |
[Time frame 1 month] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of fever and each of the respiratory symptoms
2.Improvement in hematological and laboratory parameters (lymphocyte count, Hs-CRP, ESR, TC,DC, Absolute lymphocyte count, LFT,RFT,IL-6, Ig E, Ig-G,Ig-M, LDH, Platelet count),
3.No of cases Reporting any ADR/AE
4.Number of patients referred.
5.Number of cases that required invasive or non-invasive oxygen therapy during the intervention.
6.Number of cases that progressed to multi- organ failure while under clinical trial. |
[Time Frame: 1 month]
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2020 |
| 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="1"
Days="15" |
|
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
|
1. To assess the efficacy of Guduchi Ghan Vati in the patients of positive coronavirus Disease. (Laboratory confirmation + Patients with/ without uncomplicated respiratory tract infection which may have non-specific symptoms such as fever, fatigue, cough, anorexia, malaise, muscle pain, sore throat, dyspnoea, nasal congestion, or headache).
2.To assess the clinical safety of Guduchi Ghan Vati in the patients of positive coronavirus Disease. |