| CTRI Number |
CTRI/2020/07/026568 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
10/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda Rasayan therapy for reducing risk of COVID infection in high risk individuals with comorbidities |
|
Scientific Title of Study
|
Reducing the risk of developing symptomatic Corona virus disease and reducing requirement of hospitalization by administering Ayurveda Rasayana therapy as a prophylactic therapy to individuals residing Coronavirus Hotspots and having comorbidities which increases the risk of developing severe stage Coronavirus disease or ARDS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketaki Jagtap |
| Designation |
Senior Physician |
| Affiliation |
Rasayu Ayurved Clinic |
| Address |
Rasayu Ayurved Clinic Flat No 1 and 2 Shreevijaya Apts Neelkamal Society Karvenagar Pune
Pune
MAHARASHTRA
411052
India |
| Phone |
9766897894 |
| Fax |
0000 |
| Email |
physician1@rasayuayurvedclinic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ketaki Jagtap |
| Designation |
Senior Physician |
| Affiliation |
Rasayu Ayurved Clinic |
| Address |
Rasayu Ayurved Clinic Flat No 1 and 2 Shreevijaya Apts Neelkamal Society Karvenagar Pune
Pune
MAHARASHTRA
411052
India |
| Phone |
9766897894 |
| Fax |
0000 |
| Email |
physician1@rasayuayurvedclinic.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ketaki Jagtap |
| Designation |
Senior Physician |
| Affiliation |
Rasayu Ayurved Clinic |
| Address |
Rasayu Ayurved Clinic Flat No 1 and 2 Shreevijaya Apts Neelkamal Society Karvenagar Pune
Pune
MAHARASHTRA
411052
India |
| Phone |
9766897894 |
| Fax |
0000 |
| Email |
physician1@rasayuayurvedclinic.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Rasayani .
Nande Mahalunge Road.
Mahalunge
Pune |
|
|
Primary Sponsor
|
| Name |
Ayurved Rasayani |
| Address |
48 7 Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune 411045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurved Rasayani |
48 7 Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune 411045 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ketaki Jagtap |
Rasayu Ayurved Clinic |
Rasayu Ayurved Clinic, Karvenagar Pune 411052
and
Rasayu Cancer Clinic Navi Peth Pune 411030
Pune
MAHARASHTRA |
9766897894
ketakirasayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indipendent Ethics Committee |
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 |
Pragmatic clinical study which studies the whole system personalised approch of meedcine practice. |
The investigator can prescribe the medcine which are based on his clinical logical .The medcine prescribed and dosage used will be analysed during the overall analysis of the study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals residing in Corona virus Hotspots as declared by Authorities
2 Individuals having any of the following comorbidities
3 Chronic Diabetic with more than 5 yearsof knownon set Chronic hypertensive with more than 5years of knownon set Patients with active malignancies or taking or taken anticancer therapy within last 6months Patients with chronic lowerrespiratory disease Patients with chronic liver or renalfailure Patients having immunosuppressivetherapies Or elderly person above 65 years of age with or without any comorbidities
|
|
| ExclusionCriteria |
| Details |
Pregnant women or women who are breast feeding
Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive study treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of individual becoming positive as determined by PCR or any other approved commercial or public health assays
|
Time Frame on day 30 or development of symptoms of corona virus disease
Severe stage |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes
Disease severity on an ordinal scale assessed on at weekly intervals telephonically.
Duration of stay in ICU
Percent mortality
Adverse events
CBC LFT RFT At baseline and day 30
|
Day 1 Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2020 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Background: The Coronavirus disease (COVID-19) is spreading at a great speed and has become a global pandemic. Currently in absence of any approved therapy in India to treat this disease, efforts are being made to reduce transmission via standard public health interventions based on isolation of cases and tracing of contacts. It is Predicted that such a strategy could contribute to reducing the overall size of an outbreak, but will still be insufficient to achieve outbreak control. Current evidence suggests that patients with any co- morbidity yield poorer clinical outcomes than those without. A greater number of comorbidities also is correlated with poorer clinical outcomes. Considering the poor outcomes and high mortality rates in patients with comorbidities and limitations of standard public health interventions in limiting the spread of disease it is very important to develop prophylactic therapy for individuals with comorbidities. This is a single arm, multicentric clinical study Hypothesis: Administration of oral Ayurveda Rasayana formulations will help reduce the risk of development of symptomatic or severe stage Corona virus disease in individuals with comorbidities and residing in Corona virus Hotspots.Participants will be provided with study medication thrice daily for 30days. |