| CTRI Number |
CTRI/2024/04/066411 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicines in cases of Gall stone |
|
Scientific Title of Study
|
A Role of Homoeopathic Medicines in the cases of gall stones and its management through Prospective study |
| 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 Devarshi Jayswal |
| Designation |
PG Scholar |
| Affiliation |
Smt A J savla homoeopathic medical college and research institute Mehsana Gujarat |
| Address |
department of surgery OPD no 29 ground floor
Smt A J savla Homoeopathic medical college and research institute
Pushpanjali building near district session court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7405872006 |
| Fax |
|
| Email |
devarshijayswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Trivedi |
| Designation |
Professor |
| Affiliation |
Smt A J Savla Homoeopathic medical college and research institute |
| Address |
PG department of Homoeopathic materia medica
Smt A J savla Homoeopathic medical college and research institute
Pushpanjali building near district session court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9974342824 |
| Fax |
|
| Email |
nisha.mehul26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devarshi Jayswal |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic medical college and research institute |
| Address |
department of surgery OPD no 29 ground floor
Smt A J savla Homoeopathic medical college and research institute
Pushpanjali building near district session court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7405872006 |
| Fax |
|
| Email |
devarshijayswal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic medical college and research institute
Pushpanjali building near district session court Mehsana Gujarat 384001 |
|
|
Primary Sponsor
|
| Name |
Dr Devarshi Jayswal |
| Address |
department of surgery OPD no 29 ground floor
Smt A J Savla Homoeopathic medical college and research institute Pushpanjali building near district session court Mehsana Gujarat |
| Type of Sponsor |
Other [Self] |
|
|
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 Devarshi Jayswal |
Smt A J Savla Homoeopathic Medical college and research institute |
Department of surgery OPD no 29 ground floor Pushpanjali building near district session court Mehsana
Mahesana
GUJARAT |
7405872006
devarshijayswal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic Medical college Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Potency various Potency Decimal Centecimal 50Millecimal etc
Doses as per need of cases
Medicines will be dispensed as per potency
Frequency as per need of case
Route of administration Oral
Duration of therapy upto 8 months as per need of case |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients diagnosed with gall bladder stones patient who have been clinically diagnosed with gall bladder stone and confirmed with ultrasound report
2 Age range age group of 18 to 75 years
3 Gender Includes both males and females
4 Relevant characteristics It is important to include specific characteristics such as stone size less than15 mm location stone present inside the gall bladder only number of stones or associated symptoms
5 Patient having one or multiple stones less than 15 mm will be included in study
|
|
| ExclusionCriteria |
| Details |
1 Patients with other underlying medical conditions Patients who have significant comorbidities or medical conditions such as epilepsy malignancy that could confuse the homeopathic treatment of gall bladder stones may be excluded
2 Cases which need to manage with surgical intervention and complications like obstructive jaundice perforation gangrene of gall bladder carcinoma acute intestinal obstruction acute pancreatitis
3 Patient having accelerated hypertension uncontrolled sugar level etc which need emergency management
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Significant improvement complete removal dissolution of stone with general sense of well being.
2 Improvement decreased size of stone minimum 2 to 3 mm and decreased intensity complaints
3 Status quo no any change in size of stone and/or symptoms
4 Left the treatment worsening of complaints and or increased size of stone
|
Data will be taken at the baseline and after the treatment up to 8 months of period
To assess the role of Homoeopathic medicines in the cases of Gall stone
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="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
|
This study is a prospective study pre test post test one group experimental study to assess the efficacy of Homoeopathic medicines for 8 months in 40 participants with diagnosed cases of Gall stone and its management that will be conducted as per inclusion and exclusion criteria from outpatient department and the outcomes measures will assess the reduction in size of gall stone and symptoms of patients follow up as per need of case at every 15 or 21 or 30 days up to for 8th months of duration |