| CTRI Number |
CTRI/2025/03/083373 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Bryophyllum calycinum mother tincture in case of Nephrolithiasis |
|
Scientific Title of Study
|
A Clinical Trial on the Efficacy of Bryophyllum calycinum in the Treatment of Urolithiasis A single-arm clinical trial |
| 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 Vivek Kumar Shail |
| Designation |
Associate professor |
| Affiliation |
RBTS Government of Homoeopathic Medical College and Hospital |
| Address |
Room number 1 Department of Practice of Medicine PG Block RBTS Government of Homoeopathic Medical College and Hospital Muzaffarpur Bihar India
Muzaffarpur
BIHAR
842002
India |
| Phone |
8298994658 |
| Fax |
|
| Email |
drviknih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama kumari |
| Designation |
PG Scholar |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Room number 3 Department of Homoeopathic Materia Medica PG Block RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar
India
Room number 3 Department of Homoeopathic Materia Medica PG Block RBTS Government of Homoeopathic Medical College and Hospital Muzaffarpur Bihar India
Muzaffarpur
BIHAR
842002
India |
| Phone |
09681809567 |
| Fax |
|
| Email |
anupamanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vivek kumar shail |
| Designation |
Associate professor |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Room number 1 Department of Practice of Medicine PG Block RBTS Government of Homoeopathic Medical College and Hospital Muzaffarpur Bihar India
Room number 1 Department of Practice of Medicine PG Block RBTS Government of Homoeopathic Medical College and Hospital Muzaffarpur Bihar India
Muzaffarpur
BIHAR
842002
India |
| Phone |
8298994658 |
| Fax |
|
| Email |
drviknih@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Government Medical College and Hospital |
| Address |
Ramdayalu Nagar.Muzaffarpur, Bihar,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 Vivek Kumar Shail |
RBTS Government Medical College and Hospital, Muzaffarpur,Bihar, 842002 |
PG Block of Practice of Medicine RBTS Government College and Hospital
Muzaffarpur
BIHAR |
8298994658
drviknih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RBTS Government Medical College and Hospital-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bryophyllum calycinum Q homoeopathic medicine prescribed after analysing the totality of symptom |
Selected medicine will be given in mother tincture and regular follow-up should be done at 2 weeks adhering strictly to the principles and guidelines of homoeopathy |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i Age: 15-60 years.
ii Self-reported & pre-diagnosed cases of Nephrolithiasis.
iii Patients with symptomatology of Nephrolithiasis.
iv Both sex.
v Cases confirmed either USG abdomen or X-ray. |
|
| ExclusionCriteria |
| Details |
i Patients unwilling to take part or not giving consent to join the study.
ii Diagnosed cases of systemic diseases psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
iii Patient of Age below 15 years & above 60 years.
iv Cases with impaired renal function.
v Substance abuse and/ or dependence.
vi Self-reported immune-compromised state
vii Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected from the study that it will improve the remedies for nephrolithiasis to ensure holistic and lasting relief by addressing unique symptoms and preventing recurrence and will provide a good alternative to the conventional mode of treatment with no side effect. |
11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know the importance of remedies indicating symptoms of nephrolithiasis.
To use a scoring system to assess the quality of life in nephrolithiasis.
To compare the symptomatic changes of patients before and after homoeopathic treatment. |
11 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
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
|
Kidney stone disease, also referred to as nephrolithiasis or urolithiasis, is a condition where urinary solutes crystallize and form aggregates in the urinary tract. The development of kidney stones is influenced by multiple factors, with calcium oxalate stones being the most common. The risk of stone formation is linked to genetic, metabolic, and environmental factors. Symptoms of kidney stones depend on their location—whether in the kidney, ureter, or bladder—and may remain asymptomatic initially. Over time, they can cause severe cramping pain (renal colic), flank pain, hematuria (bloody urine), urinary obstruction, infections, and hydronephrosis, often accompanied by nausea and vomiting. The purpose of this research is assess to efficacy of homoeopathic medicine in treating nephrolithiasis as well as to evaluate the effects on quality of life. |