| CTRI Number |
CTRI/2026/01/100754 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Investigation into the Incidence and Causes of Gallbladder Stones among Male Patients. |
|
Scientific Title of Study
|
To study the incidence and etiopathogenesis of gallbladder stones in male. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mazhar Ikram |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Jarahat, Faculty of unani Medicne, Aligarh Muslim university
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8218018545 |
| Fax |
|
| Email |
mazharikram2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Iqbal Aziz |
| Designation |
Professor |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Jarahat, Faculty of unani Medicne, Aligarh Muslim university
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9897008768 |
| Fax |
|
| Email |
mail.iqbalaziz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mazhar Ikram |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Jarahat, Faculty of unani Medicne, Aligarh Muslim university
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8218018545 |
| Fax |
|
| Email |
mazharikram2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Jarahat, Ajmal Khan Tibbiya College, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Jarahat |
| Address |
Ajmal Khan Tibbiya College, faculty of Unani Medicine, AMU, Aligarh |
| 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 |
| Mazhar Ikram |
Ajmal Khan Tibbiya College and Hospital |
OPD No. 1, Department of Jarahat, AKTC Hospital, Faculty of Unani Medicine, AMU
Aligarh
UTTAR PRADESH |
8218018545
mazharikram2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Jarahat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Clinically and radiologically diagnosed male patients of Cholelithiasis |
|
| ExclusionCriteria |
| Details |
Uncontrolled HTN, severe COPD, HIV positive, HBSAG reactive, HCV positive, ASA grade III and IV CLD
BMI greater than 30
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore factors in detail to understand the roles in the development of gallstones in males. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Investigation: Estrogen ,progesterone, Testosterone,Lipid profile, serum calcium,serum uric acid, Thyroid profile. |
Baseline, 2 weeks & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The formation of gallstones involves a complex interplay of genetic, metabolic,
and environmental factors. This study aims to explore these factors in detail
to understand their roles in the development of gallstones in males. |