| CTRI Number |
CTRI/2020/06/025800 [Registered on: 10/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Ayurveda in Covid 19 management. |
|
Scientific Title of Study
|
A comparative clinical study to involving Ayurvedic drug intervention in the management of COVID 19 patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adil Rais |
| Designation |
Panchakarma specialist |
| Affiliation |
LokBandhu Rajnarayan Combined Hospital |
| Address |
Panchakarma Unit
Room NO. 114
Lokbandhu Rajnarayan Combined Hospital
Lokbandhu Rajnarayan Combined Hospital
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
|
| Fax |
|
| Email |
adil.rais13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adil Rais |
| Designation |
Panchakarma specialist |
| Affiliation |
LokBandhu Rajnarayan Combined Hospital |
| Address |
Panchakarma Unit
Room no 114
LOkbandhu Rajnarayan Combined Hospital
Lokbandhu Rajnarayan Combined Hospital
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
7060272769 |
| Fax |
|
| Email |
adil.rais13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adil Rais |
| Designation |
Panchakarma specialist |
| Affiliation |
LokBandhu Rajnarayan Combined Hospital |
| Address |
Panchakarma Unit
Room no 114
Lokbandhu Rajnarayan Combined Hospital
Lokbandhu Rajnarayan Combined Hospital
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7060272769 |
| Fax |
|
| Email |
adil.rais13@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPMU National Health Mission
Uttar Pradesh Vishal complex 19-A VS marg near Akashwani Husainganj Lucknow 226001 |
|
|
Primary Sponsor
|
| Name |
National Health Mission Uttar Pradesh |
| Address |
Mainstreaming of AYUSH,
State programme Management unit, National Health Mission, Uttar Pradesh, Vishal Complex, 19 A Vidhan Sabha marg, Near Akashwani, Hazratganj, Lucknow 226001 |
| 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 |
| Dr Adil Rais |
Lokbandhu Rajnarayan Combined Hospital |
Panchakarma Unit
Room no 114
Lokbandhu Rajnarayan Combined hospital
Lucknow
UTTAR PRADESH |
7060272769
adil.rais13@gmail.com |
| Dr Adil Rais |
Ramsagar Mishra 100 bed Hospital |
Administrative office
Ramsagar Mishra 100 Bed hospital
Lucknow
UTTAR PRADESH |
7060272769
adil.rais13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokbandhu Rajnarayan Combined Hospital Lucknow |
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 |
| Comparator Agent |
Control Group (Group C) |
Warm water and Vitamin C tablet once daily for 10 days |
| Intervention |
Kashaya Group (Group A) |
Vyaghryadi kashaya 50 ml BD for 10 days
Samshamani Vati 500 mg BD for 10 days
Agnikumara Rasa 125 mg BD for 10 days |
| Intervention |
Shunthi and Rasona (Group B) |
Shunthi churna 2 gm twice daily for 10 days
Rasona kalka 1 gm once daily with warm water for 10 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients tested Positive for COVID 19.
Asymptomatic Patients or with Mild Symptoms.
Those willing to give informed Consent. |
|
| ExclusionCriteria |
| Details |
Patients below 25 years and above 60 years of age.
Patients presenting with increased severity of disease.
Those having serious Comorbidities, including Diabetes, Hypertension.
Pregnant Women
those not willing to give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce Virus Clearance Time.
To improve General Quality of Life.
To minimise the chances of Disease progression in terms of Severity.
To assess role of Ayurveda medicines in the COVID 19 Pandemic management.
To establish Ayurvedic drugs role in National programme for COVID management |
5 days and 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To ascertain role of Ayurveda in the National management of COVID 19 Pandemic |
5 days and 10 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/06/2020 |
| Date of Study Completion (India) |
30/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The outcome of the Study will be published in International peer reviewed Journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This was a randomized Clinical comparative study to be conducted at Lokbandhu Rajanarayan Combined Hospital, a COVID 19 level 2 Hospital in Lucknow, Uttar Pradesh. The prime objective was to ascertain the role of Ayurvedic medicine in the Management of COVID 19 Pandemic in India. The
observations were noticed and results were analyzed statistically. Improvement
in symptomsenhancement in Agni and recovery from COVID-19 infection was observed. The results obtained were encouraging and showed better
viral clearance and control of symptom progression in the patients placed on
Ayurvedic medications. The most significant finding
in this study was that a restrain was observed in the disease progression to
rigorous stages and evasion of population spread due to faster viral clearance
in the management of COVID-19 cases with Ayurveda drugs in both groups A and B than the control group. This paves the way to
a more integrated approach towards this pandemic wherein community spread and
progression to severe stages is the key for its restraint. From here a more
holistic and progressively planned study may be considered involving larger
sample base for the management of the more severe form of the morbidity which
is the current need of the hour to minimize the mortalities worldwide. |