| CTRI Number |
CTRI/2019/11/022159 [Registered on: 26/11/2019] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the effect of homoeopathic medicines on kidney stones |
|
Scientific Title of Study
|
An exploratory clinical trial on the effficacy of homoeopathic LM potencies on urolithiasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirmala Pratap P |
| Designation |
PG Scholar |
| Affiliation |
National homoeopathy research institute in mental health |
| Address |
National homoeopathy research institute in mental health
Sachivothamapuram PO
Kottayam 686532
Kottayam
KERALA
686532
India |
| Phone |
8606189503 |
| Fax |
04812432238 |
| Email |
nirmalaprathap@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Dastagiri |
| Designation |
Assistant Professor Dept of Medicine |
| Affiliation |
National homoeopathy research institute in mental health |
| Address |
National homoeopathy research institute in mental health
Sachivothamapuram PO
Kottayam 686532
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
04812432238 |
| Email |
drdastagirinhrimh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nirmala Pratap P |
| Designation |
PG Scholar |
| Affiliation |
National homoeopathy research institute in mental health |
| Address |
National homoeopathy research institute in mental health
Sachivothamapuram PO
Kottayam 686532
Kottayam
KERALA
686532
India |
| Phone |
8606189503 |
| Fax |
04812432238 |
| Email |
nirmalaprathap@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in mental Health
Sachivothamapuram PO
Kottayam 686532 |
|
|
Primary Sponsor
|
| Name |
Nirmala Pratap P |
| Address |
National Homoeopathy Research Institute in mental Health
Sachivothamapuram PO
Kottayam |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Nirmala Pratap P |
National homoeopathy research institute in mental health |
OPD Department of medicine
Kottayam
KERALA |
8606189503
04812432238
nirmalaprathap@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE NHRIMH KOTTAYAM |
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 |
Homoeopathic medicine |
Homoeopathic Medicines in LM potency starting from lowest to increasing doses according to the need of case
repetition every day once twice or thrice according to symptom severity
Intervention for one year |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH SYMPTOMS OF UROLITHIASIS
URINARY TRACT CALCULI OF SIZE LESS THAN 10MM |
|
| ExclusionCriteria |
| Details |
LARGE URINARY CALCULI MORE THAN 10MM
OBSTRUCTED CALCULI WITH SEVERE HYDONEPHROSIS,MACROSCOPIC HEMATURIA
IMPAIRED RENAL FUNCTION,STRUCTURAL ABNORMALITIES OF KIDNEYS,ACUTE RETENSION OF URINE MORE THAN 24 HOURS
CASES WITH COMORBIDITIES,ADVANCED PATHOLOGIES,UNCONTROLLED DIABETES MELLITUS OR HYPERTENSION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CHANGES IN THE UROLITHIASIS IN ULTRASONOGRAPHY EXPULSION OR REDUCTION IN SIZE |
1 year followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in size of calculi in ultrasonography changes in visual analogue scale scores after intervention |
1 year followup |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an exploratory trial to find the efficacy of homoeopathic LM potencies on urolithiasis. Patients presenting with symptoms of urolithiasis or pre diagnosed cases will be screened after ultrasonography,routine blood and urine investigations and enrolled considering inclusion and exclusion criteria after getting written consent.Investigations will be done at baseline,6th month and 12th month.Visual analogue scale is used to assess every case at baseline and during each follow up.The improvement in urolithiasis will be assessed with changes in Ultrasonography KUB,VAS score after intervention with Homoeopathic medicines. |