| CTRI Number |
CTRI/2021/05/033790 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Ayush medicine NOQ19 in treatment of Covid-19 patients |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, multi-centric, trial to determine the therapeutic efficacy of Ayush medicine NOQ19 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Bhardwaj |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Dept. of Community Medicine and Family Medicine, Vice Dean Research, Coordinator School of Public Health, Nodal officer Adult Vaccination
Basni phase 2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996903 |
| Fax |
|
| Email |
pankajbhardwajdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Bhardwaj |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Dept. of Community Medicine and Family Medicine, Vice Dean Research, Coordinator School of Public Health, Nodal officer Adult Vaccination
Basni phase 2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996903 |
| Fax |
|
| Email |
pankajbhardwajdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen K H |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Dept. of Community Medicine and Family Medicine, AIIMS
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9980030138 |
| Fax |
|
| Email |
naveenkhdoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sriveda Sattva Private Limited and Sri Sri Institute for Advanced Research Bangalore |
|
|
Primary Sponsor
|
| Name |
Sriveda Sattva Private Limited Sri Sri Tattva |
| Address |
III floor, No. 54/46, 39th cross, 11th main road, 4th T Block, Jayanagar, Bangalore, Karnataka, India-560041 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri Institute for Advanced Research SSIAR |
Art of Living International Center
21st KM, Kanakapura Road,
Udaypura, Bangalore South,
Karnataka-560 082, India
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Bhardwaj |
All India Institute of Medical Sciences |
Additional Professor, Dept. of Community Medicine and Family Medicine Basni phase 2
Jodhpur
RAJASTHAN |
8003996903
pankajbhardwajdr@gmail.com |
| Dr Monika Pathania |
All India Institute of Medical Sciences Rishikesh |
Associate professor
Department of medicine
Level 6, Admin Block A
AIIMS Rishikesh
Dehradun
UTTARANCHAL |
8126021556
anshupathania27@gmail.com |
| Dr G Kalaiselvan |
Sri Manakula Vinayagar Medical College and Hospital |
Professor and Head
Department of Community Medicine
Kalitheerthal kuppam, Madagadipet Puducherry
Pondicherry
PONDICHERRY |
9843155060
kalaiselvanmd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC Sri Manakula Vinayagar Medical College and Hospital Puducherry |
Approved |
| Institutional Ethics Committee AIIMS Jodhpur |
Approved |
| RRB AIIMS Rishikesh |
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: JVARAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurveda Medicine NOQ 19 |
500 mg , 2tabs thrice daily orally with water in morning, Noon and Night.
Duration of therapy: 7 days |
| Comparator Agent |
Placebo |
500 mg , 2tabs thrice daily orally with water in morning, Noon and Night.
Duration of placebo: 7 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic COVID 19 infection with or without comorbidities
Willingness to participate in the study
Indian nationals
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years or more than 75 years
Pregnancy and Lactation
Patient not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of NOQ19 in COVID 19 patients in time to become SARS COV2 RT-PCR negative, reducing the symptoms and duration of hospital stay |
7 days for each participant |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Effect of NOQ19 therapy on laboratory parameters - CBC, RBS, KFT, LFT, CRP |
Entry and Exit |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2021 |
| Date of Study Completion (India) |
30/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The current pandemic of Covid-19 has shaken the entire world. In spite of various scientific researches and technological advancements exact treatement to cure the disease is yet to be discovered. Ayurvedic medicine NOQ 19 is a polyherbal formulation that has immunomodulating and immune enhancing properties. This drug is licensed by Drug licensing authority, Department of AYUSH, Government of Karnataka. The present randomized, double blind, placebo controlled, multi-centric trial is planned to determine the therapeutic efficacy of Ayurvedic medicine NOQ19 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment. Three medical institutes providing Covid 19 care will be involved in conducting this trial. From each center 50 covid positive patients admitted in the hospital in the age group 18-75 years will be recruited and randomized into treatment and control arm. Following randomization 25 of them will be given Ayurvedic medicine NOQ 19 along with standard treatment and other 25 will receive placebo plus standard treatment. The follow up period will be 7 days. Outcome measures that will be assessed are time to become SARS CoV2 RT PCR negative, reduction in symptoms and duration of hospital stay. Apart from this the blood samples will be collected on the day of entry and exit to measure CBC, RBS, KFT, LFT, CRP. |