| CTRI Number |
CTRI/2024/05/068108 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Symptomatic treatment of case of renal colic through Homoeopathy |
|
Scientific Title of Study
|
A Clinical trials to study the dominating role of particular symptoms of Phatak repertory through cases of renal colic |
| 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 Mohammed Sajim |
| Designation |
PGT Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Room Number 202 PG Building Academic Block
RBTS Government Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur BIHAR 842002 India |
| Phone |
7551127786 |
| Fax |
|
| Email |
sajim0918@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ram Kumar |
| Designation |
Associate Professor Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Room Number 202 PG Building Academic Block
RBTS Government Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur BIHAR 842002 India |
| Phone |
9470039820 |
| Fax |
|
| Email |
drramkumar26@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ram Kumar |
| Designation |
Associate Professor Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Room Number 202 PG Building Academic Block
RBTS Government Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur BIHAR 842002 India |
| Phone |
9470039820 |
| Fax |
|
| Email |
drramkumar26@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.B.T.S. Govt. Homoeopathic Medical College & Hospital,
Ramdayalu Nagar, Muzaffarpur, Bihar
Pin code -842002
|
|
|
Primary Sponsor
|
| Name |
R.B.T.S. Govt. Homoeopathic Medical College & Hospital, |
| Address |
Ramdayalu Nagar, Muzaffarpur, Bihar
Pin code -842002
|
| 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 Ram Kumar |
Surgery OPD 4 and Practice of Medicine OPD 1 |
Department of Surgery OPD 4 and Department of Practice of Medicine OPD 1 at Hospital Block RBTS Government College and Hospital Muzaffarpur BIHAR |
9470039820
drramkumar26@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: N22||Calculus of urinary tract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine
|
Selected Medicine is Prescribed in 30C, 200C and 1M Potency for Oral Intake and Followup is Done at 15 Days Interval |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in the study
2.Patients of both Gender, all religions and any socio-economic status.
3.Patients of Age group 30 to 50 years.
4.Cases with radiographic evidence (X ray and ultrasound of kidney/ureter/bladder [KUB]) of calculi in KUB
5.Calculi size less than 11 mm as confirmed by USG.
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to take part in the study or not giving consent.
2.Patients with co-morbidity – systemic illness/ psychiatric illness or other illness affecting quality of life.
3.Pregnant individuals from the trial due to potential variations in symptom presentation.
4.Cases with gross developmental defects or structural abnormality of kidney
5.Patients of self-reported immuno-compromised state.
5.Stone Size greater than 11 mm as confirmed by USG.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultimately, the expected outcomes aim to advance our understanding of the role of symptoms in Phatak Repertory in guiding effective homeopathic interventions for patients with renal colic, fostering evidence-based practices in the field of homeopathy. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the most common and dominating symptoms in cases of renal colic using Phatak Repertory. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| Date of Study Completion (India) |
13/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
primary aim of this clinical trial is to systematically study and analyze the
dominating role of particular symptoms listed in Phatak’s Repertory in cases of
renal colic. The focus will be on identifying key symptoms that consistently
manifest in patients experiencing renal colic, as per the repertory, to enhance
our understanding of the disease and contribute valuable insights to
homeopathic practice. As per studies and research till
date on Phatak repertory, it is modern clinical repertory and very useful in
clinical cases, the intention behind this research is to observe and identify
the dominating role of particular symptoms that can lead to more accurate
remedy selection, potentially reducing treatment time and pain severity in
renal colic patients.
Renal colic, characterized by severe
flank pain due to the passage of a kidney stone, is a common and debilitating
condition. While effective
treatments exist, managing the acute pain can be challenging. Homeopathic remedies
offer a potential alternative, but their selection often relies on subjective
symptom matching, leading to uncertainty and potentially ineffective treatment.
In Phatak’s
Repertory, a comprehensive homeopathic symptom database, could hold the key to
identifying particular, dominating symptoms for targeted remedy selection in
renal colic cases. |