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CTRI Number  CTRI/2020/03/023820 [Registered on: 06/03/2020] Trial Registered Prospectively
Last Modified On: 03/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Percentage of Depression In Patients Attending NIUM Hospital  
Scientific Title of Study   Assessment of Depression and its Determinants in the patients attending NIUM Hospital - A cross sectional study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saba Varsee 
Designation  PG Scholar 
Affiliation  National Institute Of Unani Medicine 
Address  National Institute Of Unani Medicine, Kottegepalya, Magadi Main Road, Bengaluru
National Institute Of Unani Medicine, Kottegepalya, Magadi Main Road, Bengaluru
Bangalore
KARNATAKA
560091
India 
Phone  8400369813  
Fax    
Email  sabawarsi24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abdul Haseeb Ansari 
Designation  Associate Professor 
Affiliation  Deptt. of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine 
Address  Deptt. of Tahaffuzi wa Samaji Tib (PSM), National Institute of Unani Medicine, Kottegepalya, Magadi Main Road, Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9448258140  
Fax  23584180  
Email  ahansari_001@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abdul Haseeb Ansari 
Designation  Associate Professor 
Affiliation  Deptt. of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine 
Address  Deptt. of Tahaffuzi wa Samaji Tib (PSM), National Institute of Unani Medicine, Kottegepalya, Magadi Main Road, Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9448258140  
Fax  23584180  
Email  ahansari_001@rediffmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine Kottigepalaya Magadi Main Road Bangalore 560091 
 
Primary Sponsor  
Name  National Institute Of Unani Medicine 
Address  Kottigepalya Magadi Main Road Bengaluru 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Saba Varsee  National Institute of Unani Medicine   Specialised OPD 3 National Institute of Unani Medicine Hospital, Kottigepalya Magadi Main Road BANGALORE 560091
Bangalore
KARNATAKA 
8400369813
0
sabawarsi24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIUM/IEC/2018-19/018/TST/03  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: E888||Other specified metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patient willing to participate 
 
ExclusionCriteria 
Details  Patient below 18 years of age and above 60 years
Patient unwilling to cooperate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Assess The Depression In The Patients Attending National Institute of Unani Medicine Hospital  once a visit 
 
Secondary Outcome  
Outcome  TimePoints 
To Find The Determinants Of Depression In Patients Attending National Institute of Unani Medicine Hospital  once a visit 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   10/03/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Depression is a major public health problem, contributing to significant morbidity, disability as well as mortality, along with significant socioeconomic losses. It affects large number of children, adolescents, middle-aged groups and elderly, both men and women, residing in urban, rural areas and slums of India. India is home to an estimated 57 million people (18% of the global estimate) affected by depression. Globally, the total number of people with depression was estimate to exceed 300 million people equivalent to 4.4% in 2015. According to World Health Organization (WHO), Depression is a common mental disorder, characterized by persistent sadness and a loss of interest in activities that you normally enjoy, accompanied by an inability to carry out daily activities, for at least two weeks. In Unani Medical Hippocratic writings (fourth century BC), serious mental illness was ascribed mainly to physical cause, which were represented in the theory that health depended on correct balance of the four body ‘humour’ blood, phlegm, yellow bile, and black bile. Melancholia was ascribed to an excess of black bile.8 Melancholia, formerly the psychological condition known as depression. The term now refers to extreme features of depression, especially the failure to take pleasure in activities. Depression is the common cold of mental disorder most people will be affected by depression in their lives either directly or indirectly through a friend or family member. In the classical literatures of Unani System of Medicine, Melancholia is defined as a disease in which there is disturbance of thoughts and intellect. It is characterized by social isolation, loneliness, negative thoughts, mistaken belief, fear of objects by which an average person is not afraid, loss of interest and pleasure in usual activities, hallucination, excessive grief, mainly due to disproportion (excess) of  Sawdā’ or deterioration in the quality of it. Depression is associated with medical illness like cardiovascular diseases, diabetes mellitus, cancer, neurologic disorders, hypothyroidism etc. The life time prevalence of depression in HIV present individuals has been estimate at 22-45%.

 

 

 
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