| CTRI Number |
CTRI/2023/11/060154 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
15/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate efficacy of Eladi yog in Mritrakrichhra |
|
Scientific Title of Study
|
Randomised open controlled clinical study to evaluate efficacy of Eladi yog in Mutrakrichhra with special ref erence to Urinary Tract Infection |
| 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 Tejesh Dhanraj Malbhage |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic college PGT and RC kodoli |
| Address |
Yashwant Ayurvedic college PGT and RC
kodoli
OPD no 4 Shalyatantra Department
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9021289269 |
| Fax |
|
| Email |
tmalbhage@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayaji Desai |
| Designation |
Associate professor |
| Affiliation |
Yashwant Ayurvedic college PGT and RC kodoli |
| Address |
Yashwant Ayurvedic college PGT and RC
kodoli
OPD no 4 Shalyatantra Department
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423282354 |
| Fax |
|
| Email |
drsayaji@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejesh Dhanraj Malbhage |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic college PGT and RC kodoli |
| Address |
Yashwant Ayurvedic college PGT and RC
kodoli
OPD no 4 Shalyatantra Department
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9021289269 |
| Fax |
|
| Email |
tmalbhage@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic college PGT and RC
Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Tejesh Dhanraj Malbhage |
| Address |
Yashwant Ayurvedic college PGT and RC
Kodoli |
| 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 Tejesh Dhanraj Malbhage |
Yashwant Ayurvedic college PGT and RC Kodoli |
Yashwant Ayurvedic college PGT and RC
Kodoli
OPD no 4 Shalyatantra Department
Kolhapur
MAHARASHTRA |
9021289269
tmalbhage@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:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | liquid Disodium hydrogen citrate | Disodium hydrogen citrate is urinary alkalinzer |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Mootrakrichhra according to classical sign & symptoms
H/o- Urinary Tract Infection not more than 7 days & didn’t taken any antibiotics
DukhenMutrapravritti
MutraDaha
MutrendriyaShool
KukshiShool
VankshanShool
BastiShool
SwalpaMuhurmuhuMutrapravritti
|
|
| ExclusionCriteria |
| Details |
Subjects having surgical problems of UTI and its complications
Congenital Anomalies
K/C/O: BPH / Cancer / T.B / DM / HTN / STD / Impaired Renal Function and any other systemic disease
Renal Calculi, Pyelonephritis
Pregnant and Lactating Woman
Ashmarijanya, Shukrajanya, Purishaj and ShalyajMutrakrMutrakrichhra
Patient above 40 years and below 16 years
Any Comorbid condition |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of Eladi Yog in Mutrakrichhra with special reference to Urinary Tract Infection. |
To study the role of Eladi Yog in Mutrakrichhra with special reference to Urinary Tract Infection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the literature of Eladi Yog in disease Mutrakrichhra w.s.r. to UTI.
To study the efficacy of Eladi Yog on sign and symptoms of Mutrakrichhra in 14 days.
To study the diseases of mutrakrichhra according to ayurvedic science & modern science
To observe adverse effects if any.
|
14 days interval |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| 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 is a randomised controlled clinical study to evaluate the efficacy of Eladi Yog in Mutrakrichhra with special reference to urinary tract infection. Observations will be made upon the symptoms of Mutrakrichhra. Study will be carried out in the OPD of Shalyatantra Department of Yashwant Ayurvedic College, Kodoli. |