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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
Intervention / Comparator Agent
|
|
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%.
|