| CTRI Number |
CTRI/2020/09/027911 [Registered on: 18/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Kshara] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Tila Nala Kshara For The Treatment Of Stones Of Urinary System. |
|
Scientific Title of Study
|
"Study Of Efficacy Of Tila Nala Kshara In The Management Of Mutrashmari With Special Reference To Urolithiasis: Randomized Open Labelled Controlled Clinical Trial" |
| Trial Acronym |
STIM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Madhukar Bhagat |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Department Of Shalyatantra
Government Ayurved College And Hospital Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9096344563 |
| Fax |
|
| Email |
shubham.29may@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Hemant Rohidas Maske |
| Designation |
Assistant Professor And Guide |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Department Of Shalyatantra
Government Ayurved College And Hospital Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422185884 |
| Fax |
|
| Email |
hemantmaske2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Hemant Rohidas Maske |
| Designation |
Assistant Professor And Guide |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Department Of Shalyatantra
Government Ayurved College And Hospital Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422185884 |
| Fax |
|
| Email |
hemantmaske2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Own Funded and Will be Carried out at Government Ayurved College and Hospital Nanded |
|
|
Primary Sponsor
|
| Name |
Shubham Bhagat |
| Address |
Department of Shalyatantra
Government Ayurved college and hospital
Vazirabad
Nanded
|
| 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 |
| Vd Hemant Rohidas Maske |
Government Ayurved College And Hospital |
Department of Shalyatantra
Government Ayurved College and Hospital
Vazirabad
Nanded 431601
Nanded
MAHARASHTRA |
9422185884
hemantmaske2010@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: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kadali Kshara |
Kadali Kshara
Route of administration- oral
Dose-500mg twice a day
Duration-28 days |
| Intervention |
Tila Nala Kshara |
Tila Nala Kshara
Route of administration-oral
Dose-1gm twice a day
Duration -7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient Of Mutrashmari Of Size Minimum 4mm To Maximum 20mm
Patients Of Obstructive As Well As Non Obstructive Pathology With Normal KFT
Patients Of Mutrashmari With Renal And/Or Ureteric And/Or UVJ Calculus |
|
| ExclusionCriteria |
| Details |
Patients Of Obstructive Pathology With Changes Of Severe Hydronephrosis In USG
Patient Is Having Uncontrolled Diabetes And/Or Hypertension And/Or Asthma And Other Major Systemic Illness
Impaired Renal Function
Pregnant And Lactating Mother
Urinary Calculi Having Size More Than 20mm
Kshara Ayogya Vyadhi |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out how this drug reduces the size of Mutrashmari or promotes its expulsion |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To establish the better medicinal alternative in the management of Mutrashmari
To find out whether this drug shortens the duration of treatment of Mutrashmari than other drugs |
7days |
|
|
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)
|
02/10/2020 |
| 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="2"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
"This Study Is Randomized Open Labelled Controlled Clinical Trial Of Efficacy Of Tila Nala Kshara In The Management Of Mutrashmari With Special Reference To Urolithiasis for 7 days and follow up and assessment on 7th, 14th, 21st and 28th Day.This study is conducted as a compulsory part of PG course at single centre.The primary outcome is to find out whether this drug reduces the size of Mutrashmari or promotes its expulsion |