| CTRI Number |
CTRI/2024/10/076072 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Conceptual and Survey Study Of Gall bladder Stones In Females Of different Individuals |
|
Scientific Title of Study
|
To Study the incidence of Cholelithiasis
hissat e marara in females of different temperaments
]
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shereen begum |
| Designation |
PG Scholar |
| Affiliation |
Govt Nizamia TIbbi College and Hospital |
| Address |
OPD 6 Dept of kulliyat e tibb,
Govt Nizamia Tibbi College and hospital charminar hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9160899581 |
| Fax |
|
| Email |
drshereentabassum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Yousuf uddin |
| Designation |
Guide and HOD |
| Affiliation |
Govt Nizamia TIbbi College and Hospital |
| Address |
OPD 6 Govt Nizamia Tibbi college and hospital charminar hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9912904786 |
| Fax |
|
| Email |
yousufmohd96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shereen begum |
| Designation |
PG Scholar |
| Affiliation |
Govt Nizamia TIbbi College and Hospital |
| Address |
OPD 6 Dept of kulliyat e tibb Govt Nizamia Tibbi college and hospital charminar hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9160899581 |
| Fax |
|
| Email |
drshereentabassum@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Nizamia tibbi college and hospital charminar hyderabad 500002 Telangana India |
|
|
Primary Sponsor
|
| Name |
Govt Nizamia tibbi college and hospital |
| Address |
Govt Nizamia Tibbi college and hospital charminar hyderabad 500002 Telangana India |
| Type of Sponsor |
Government medical college |
|
|
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 Shereen Begum |
Govt Nizamia Tibbi college and hospital |
opd 6 Dept of kulliyat e tibb Govt Nizamia Tibbi college and hospital charminar 500002 hyderabad India
Hyderabad
TELANGANA |
9160899581
drshereentabassum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients attending opd of Govt Nizamia tibbi college and hospital.
Sex : females
|
|
| ExclusionCriteria |
| Details |
Females of age below 18yrs and above 55 yrs
Male
Pregnant women
Pancreatitis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Prove the statistical analysis of incidence of cholelithiasis in females individual of different temperaments. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the majority of patients with particular temparaments in cholelithiasis |
5 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/11/2024 |
| 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="0"
Months="4"
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
|
In India Prevalence of cholelithiasis is about 10 - 22 percent in general population. To Estimate the prevalence of cholelithiasis in females of different temperaments.
Cholelithiasis are twice more frequent in women than in men so the assessment of mizaj is needed.
To create awareness about Mizaj and its importance. |