| CTRI Number |
CTRI/2024/08/072675 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To know relationship between temperament and BMI of individual |
|
Scientific Title of Study
|
Relationship between Body Weight and Mizaj in Volunteers of NIUM Campus, Bengaluru: A Cross-Sectional Study |
| Trial Acronym |
NIUM-National Institute of Unani Medicine |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sana khan |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine , Magadi Main Road, Kottigepalya, Bengaluru, Karnataka,560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9634521538 |
| Fax |
|
| Email |
khansananazmul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abdul Haseeb Ansari |
| Designation |
Professor |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine, Magadi Main Road, Kottigepalya, Bengaluru, Karnataka,560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9448258140 |
| Fax |
|
| Email |
ahansari001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sana khan |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine, Magadi Main Road, Kottigepalya, Bengaluru, Karnataka,560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9634521538 |
| Fax |
|
| Email |
khansananazmul@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.3 Department Of tahafuzi wa samaji tib National Institute Of Unani Medicine Magadi Main Road Bengaluru Karnataka 560091 India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Department Of tahafuzi wa samaji tib National Institute Of Unani Medicine Magadi Main Road Bengaluru Karnataka 560091India |
| 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 |
| Dr Sana Khan |
National Institute Of Unani Medicine |
Department Of tahafuzi wa samaji tib National Institute Of Unani Medicine Magadi Main Road Bengaluru Karnataka 560091 India
Bangalore
KARNATAKA |
9634521538
khansananazmul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication Of Decision of the Institutional Ethics Committee(IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
volunteers should not be bedridden, mentally retarded, pregnant or lactating women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Volunteers of NIUM, Bengaluru Campus (Students, Staff, patient’s attendants)
2.Age group ≥18 years - ≤60 years
3.Volunteers of either gender
|
|
| ExclusionCriteria |
| Details |
1.Unstable, bedridden, mentally retarded and with serious illness individuals
2.Pregnant and lactating women
3.individuals unwilling to cooperate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the reationship between BMI and mizaj of volunteers |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To make aware the volunteers of their body weight variation and the possibility of intervention according to their Mizāj. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="215"
Sample Size from India="215"
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)
|
27/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BMI as a measurement is typically used to gauge
the risk of developing chronic conditions such as diabetes, hypertension,
depression, and cancer. The BMI calculation will fall within a
numerical range, which places an individual into one of four categories. This
data is used by researchers and physicians to educate patients and the public about
potential health risks detected within a specified category. Researchers
continue to evaluate the correlation between BMI and long-standing illness. The use of Body Mass Index (BMI) is usually more predictive and
accurate in the assessment of the state of well-being of individuals.
Studies reveal the mean BMI showed an increasing trend
over the decades. A raised BMI value is an established risk factor for coronary
heart disease, ischaemic stroke, type-2 diabetes mellitus and carcinoma. Both low and high BMI are associated with an increased risk of mortality.
The weight of an individual is not only depend upon
the amount of fat and muscles but also on other components of the body a
decrease or increase in weight is also influenced by the Mizāj (temperament) of an individual.
In the Unani System of Medicine, Mizāj is an important parameter and if there is a change in Mizāj (Dam, Ṣafra’, Sawda’, Balgham)
or dominance of any of these Mizāj may also affect the structure
of the human body. So if Mizāj is determined accurately (assessment
is done correctly), any changes in the human body (regarding its weight and
structure) can be evaluated. Therefore, body weight that depends upon structure
must be measured accurately so that in case of a decrease or increase in weight
can be controlled by possible changes in the Mizāj of the individual.
It is the need
of the hour to make the patients and their relatives aware of the disease and
its risk factors. To make conscious the patients of higher BMI about
their Mizāj variation
and the possibility of intervention according to the Unani System of Medicine. Based on the study, the
researcher may provide lifestyle modifications so that the patient may benefit
from them.
Body habitus, as described by BMI is related to skeletal size, muscle
mass and adiposity. The objectives of this work are (i) to compare the value of
Body Mass Index in the individuals of different Mizāj. (ii) to find out whether BMI can be understood in terms of the state
of flesh or fat or both, of different Mijāz individuals, as described in Unani literature. |