| CTRI Number |
CTRI/2020/09/028132 [Registered on: 29/09/2020] Trial Registered Prospectively |
| Last Modified On: |
28/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A cross sectional study to assess the impact of COVID-19 on patints with non communicable disease at AYUSH LSD clinics |
|
Scientific Title of Study
|
Impact and management of Covid-19 Pandemic on patients with Non-communicable disease: A cross sectional study at AYUSH LSD Clinics of Krishna and Darjeeling District |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varanasi Roja |
| Designation |
Research Officer(H)/Scientist-2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area
opp D Block Janakpuri
New Delhi
Clinical Research
Room no.317
South West DELHI 110058 India |
| Phone |
9999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer(H)/Scientist-2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area
opp D Block Janakpuri
New Delhi
Clinical Research
Room no.303
South West DELHI 110058 India |
| Phone |
9873404012 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area
opp D Block Janakpuri
New Delhi
Clinical Research
Room no. 406
South West DELHI 110058 India |
| Phone |
9811952274 |
| Fax |
|
| Email |
oberai.praveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy,
61-65, Institutional Area
opp. D Block, Janakpuri, New Delhi, 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area
opp D Block Janakpuri
New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Gurudev Choubey |
Clinical Research Unit (Homoeopathy) |
Gokhel Road (Near Matri Bhandar), Arobindopally, Siliguri – 734006
Clinical Research
Room no.1 Darjiling WEST BENGAL |
7908955160
gurudev.choubey@gmail.com |
| Dr Ch Raveendar |
Regional Research Institute(Homoeopathy) |
Dr. GGH Medial College Campus, Eluru Road, GUDIVADA 521 301 (AP)
2nd floor
Room no. 1 Krishna ANDHRA PRADESH |
9849126380
drraveendarch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central 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
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1Patients under treatment for non communicable diseases at AYUSH LSD clinic at Krishna and Darjeeling district
2Patient who give their verbal consent |
|
| ExclusionCriteria |
| Details |
Patients who do not give verbal consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the impact of covid19 on patients suffering from non communicable diseases |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of Covid-19 Pandemic on Daily Routine and Chronic Care |
one time |
|
|
Target Sample Size
|
Total Sample Size="450" Sample Size from India="450"
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)
|
05/10/2020 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In India the COVID-19 cases are growing fast with each passing day. People are physically, emotionally and psychologically disturbed. The challenges are many more with patients having chronic conditions. It is clear that the pandemic will seriously undermine global efforts to attain the sustainable development goals. Among the major challenges are increased indoor time leading to increased exposure of other behavioral risk factors for non-communicable diseases (NCDs) such as unhealthy diet, alcohol use, stress, inadequate access to essential medicines. This time-sensitive study among higher-risk, adults living with chronic conditions to determine how they are managing their conditions during the pandemic, their current awareness of COVID-19, their perception of the seriousness of its threat, their level of worry and concern related to contracting the virus, whether it is affecting their daily routine or existing plans, how prepared they feel to handle an outbreak, and their confidence in the government response. The objective of the study is to determine the impact of Covid19 pandemic on patients with Non-communicable disease. A study concluded that many adults with comorbid conditions lacked critical knowledge about COVID-19 and, despite concern, were not changing routines or plans. Noted disparities suggest that greater public health efforts may be needed to mobilize the most vulnerable communities. This cross sectional study is planned to determine the impact of covid19 in managing their conditions during the pandemic, their current awareness of COVID-19, their perception of the seriousness of its threat, their level of worry and concern related to contracting the virus, whether it is affecting their daily routine or existing plans, management of chronic condition and if affected with Covid19 , how they have managed further. |