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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
 
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.

 
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