| CTRI Number |
CTRI/2021/04/032804 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
07/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of AEV01 (Kutki) for Mild COVID19 Elderly patients |
|
Scientific Title of Study
|
A Randomized, Placebo controlled, double blinded, parallel group clinical study to evaluate the efficacy and safety of AEV01 (Kutki) for Mild COVID19 in Elderly patients at risk of complications. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AEV01/008/21. Version: 1.0 |
Protocol Number |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
PM Medical Centre |
| Address |
Room no:2, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
632401
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanitha Muralikumar |
| Designation |
Director- Clinical Research |
| Affiliation |
Sri Sai Ram Ayurveda Medical College |
| Address |
Clinical Research Wing,Room no.1,Sri Sai Ram Ayurveda Medical College, Sai Leo Nagar, Poonthandalam, Tambaram West, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9176677750 |
| Fax |
|
| Email |
drvmkmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
PM Medical Centre |
| Address |
Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
632401
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu. |
|
|
Primary Sponsor
|
| Name |
PM Medical Centre |
| Address |
Wallajapet, Ranipet, Tamil Nadu. |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Kannan |
PM Medical Centre |
Room no:2, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU |
7708925866
srkguruvarshan@gmail.com |
| Dr Vamseedhar Annam |
Rajarajeswari Medical College and Hospital |
Department of Pulmonary Medicine, COVID OP/Ward,
Rajarajeswari Medical College,
#202, Kambipura, Kengeri Satellite Town, Mysore Road, Karnataka - 560074
Mysore
KARNATAKA |
9701500592
vamseedhar_a@yahoo.com |
| Dr Vanitha Muralikumar |
Sri Sai Ram Ayurveda Medical college and Research centre |
COVID Dedicated -OPD/Ward,Sri Sai Ram Ayurveda Medical college and Research centre,
Sai Leo Nagar, West Tambaram, Chennai- 44.
Chennai
TAMIL NADU |
9176677750
drvmkmd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| ECHR- Dhanwanthralaya Ayurveda Speciality Hospital |
Approved |
| Institute Ethics Committee - Sri Sai Ram Ayurveda Medical College & Research Centre |
Approved |
| PM Ethics Committee |
Approved |
| Rajarajeswari Medical College and Hospital |
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. Ayurveda Condition: Janapadoddhwansa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule. AEV01 100 mg |
AEV01 is a root extract of Kutki (Picrorhizakurroa 100 mg)
Given thrice daily orally after food for 30 days
|
| Comparator Agent |
Placebo capsule |
Placebo capsule given thrice daily orally after food for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing and able to provide written informed consent prior to performing study procedures.
2. Adult patients aged more than 50 years with SARS-CoV-2 infection and mild disease.
Patients with Mild (uncomplicated) Illness is defined as –
a.Diagnosed with COVID-19 by a standardized RT-PCR assay AND
b.Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
c.No signs of a more serious lower airway disease AND
d.RR<20, HR <90, oxygen saturation (pulse oximetry) > 94% on room air
|
|
| ExclusionCriteria |
| Details |
1. Participants with moderate and severe illness of COVID19.
2. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
3.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR< 30)
4.Immuno-compromised patients on medications.
5.Participation in any other clinical trial of an experimental treatment for COVID-19
6. Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time for clinical improvement , which is defined as;
1. Normalization of pyrexia and body pain
2. Respiratory rate less than 24/minute
3.Spo2 rate greater than 94%
4. Relief from cough and maintenance of above for more than 72 hours.
|
Day 1 to Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage of subjects reporting each severity rating on a 8-point ordinal scale.
2. Change from baseline in the following lab parameters namely, CBC, ESR, RBS, CRP, LFT, RFT, Serum electrolytes, serum ferritin, D-dimer, CD4, CD8, TNF-ï¡, IL-6, Covid-19 IgM & IgG and HRLCT scan.
3.Change from baseline in National Early Warning Score
4.Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) / SAEs
5.Time to Recovery
|
Day 1 to Day 30 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/04/2021 |
| Date of Study Completion (India) |
27/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| The selected 70 Participants will be randomized into 2 groups with 35 in each group. Placebo Group patients diagnosed as mild SARS-CoV-2 infection will receive Placebo + standard of care treatment(as per hospital regulation) as per the WHO/ICMR guidelines and Test Group patients diagnosed as mild SARS-CoV-2 infection will receiveAEV01+ standard of care treatment (as per hospital regulation) as per the WHO/ICMR guidelines. The primary outcome measures will be to assess the efficacy of the drug as follows; Time for clinical improvement [Time Frame: up to Day 30], which is defined as; 1. Normalization of pyrexia and body pain 2. Respiratory rate less than 24/minute 3.Spo2 rate greater than 94% 4. Relief from cough and maintenance of above for more than 72 hours. The secondary outcome measure will be ; 1. Percentage of subjects reporting each severity rating on a 8-point ordinal scale. 2. Change from baseline in various lab parameters. The results of the Placebo and treatment arm will be analyzed and compared. | |