| CTRI Number |
CTRI/2025/09/094420 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effects of individualised homoeopathic medicine in patients with cholelithiasis in age group 18 to 60 years |
|
Scientific Title of Study
|
Study of efficacy of individualised homoeopathic medicine in the treatment of cholelithiasis patients in the age group 18-60 |
| 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 Dhina Jalan |
| Designation |
PG student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri 411018 |
| Address |
Homoeopathic materia medica
room no.4
ground floor
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri pune 411018 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
8329619769 |
| Fax |
|
| Email |
dhinajalan1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhina Jalan |
| Designation |
PG student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri 411018 |
| Address |
Homoeopathic materia medica
Room no. 4
Ground floor
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8329619769 |
| Fax |
|
| Email |
dhinajalan1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaphekar P A |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri 411018 |
| Address |
Homoeopathic materia medica
Room no. 4
Ground floor
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9423580018 |
| Fax |
|
| Email |
priyagauri.chaphekar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD and IPD complex
department of Homoeopathic materia medica
room no. 4
ground floor
Dr.D Y Patil Homoeopathic Medical college and research centre sant tukaramnagar Pimpri pune 411018 maharashtra India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [no sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhina Jalan |
Dr D Y Patil Homoeopathic Medical College And Research Centre |
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
08329619769
dhinajalan1999@gmail.com |
| Dr Dhina Jalan |
Keshav Nagar peripheral OPD |
Keshar Nagar Chinchwad Pune
Pune
MAHARASHTRA |
08329619769
dhinajalan1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College and Research Centre Institutional Ethics 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 |
Individualised Homoeopathic Medication
|
Dose 30 potency
frequency thrice daily
route of administration oral
total duration 6months |
| Comparator Agent |
nil |
nil as it is single arm study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18yrs to 60yrs
All genders
Gall stone of size till 5mm
Multiple or single stone both
Sludge
|
|
| ExclusionCriteria |
| Details |
Age group below 18yrs and above 60yrs
Gall stone of size more than 5mm
Patients having emergency of obstruction or torsion , emphysematous, gangrenous or suppurative gall bladder , cholangitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the size of stone |
To reduce the size of stone in 3 to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief |
3 to 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2025 |
| 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 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
|
| An Experimental interventional single arm study will be done on patients who are diagnosed with cholelithiasis who are going to be managed by Individualised homoeopathic medication The outcome will be seen on the basis of symptomatic relief which will be assessed using The Gastrointestinal Quality of Life Index (GIQLI) scale and size of gall stones by doing Ultrasonography | |