| CTRI Number |
CTRI/2024/11/077048 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial to Study the Effectiveness of Erand Leaf Alkaline Extract in the Management of Urinary Tract Infection and Painful Urination |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study to Evaluate the Efficacy of Eranda Patra Kshara in the Management of Mutrakrucchra with Special Reference 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 Shubham Shahaji Borse |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9922953663 |
| Fax |
|
| Email |
shubhborse7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramachandra Shedge |
| Designation |
HOD Professor in Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Shahaji Borse |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9922953663 |
| Fax |
|
| Email |
shubhborse7@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Tal Walawa District Sangli 415409 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Shahaji Borse |
| Address |
Department Of Shalyatantra LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Tal Walawa District Sangli 415409 Maharashtra India |
| 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 Shubham Shahaji Borse |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre |
Department of Shalyatantra Division No 1 Room No 1 LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Tal Walwa Dist Sangli 415409
Sangli
MAHARASHTRA |
9922953663
shubhborse7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: MUTRAKRUCCRAM, (2) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yavakshara, Reference: धनà¥à¤µà¤¨à¥à¤¤à¤°à¤¿à¤¨à¤¿à¤˜à¤£à¥à¤Ÿà¥ - २ शतपà¥à¤·à¥à¤ªà¤¾à¤¦à¤¿à¤µà¤°à¥à¤—, Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda Patra Kshara, Reference: à¤à¤¾.पà¥à¤°.नि.६४, Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Water ), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having sign and symptoms of Mutrakruchra (Sadaha, Saruja Mutrapravruti) etc.
2.The age group between 18 to 60 years.
3.Patients irrespective of religion, sex and socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy & lactation.
2.Prostate enlargement.
3.Patients who having known case of any part of urinary tract, Renal failure, chronic kidney diseases, Renal calculus, Nephritis, Pyelonephritis.
4.Phimosis or paraphimosis.
5.Patients having known case of systemic illness like DM, HTN, Asthma, HIV, HbsAg.
6.Patients who having autoimmune disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Sign and Symptoms of jwar, Sadah mutrata, Sarakta mutrata, Saruja mutrata due to Urinary Tract Infection. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant Decrease in Sign and Symptoms of Kruchra mutrata, Sadah mutrata, Muhurmuhur mutrata, Puya mutrata due to Urinary Tract Infection. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
26/11/2024 |
| 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
|
Objective: To
study the efficacy of Eranda-Patra Kshara is Effective in the Management
of Mutrakrucchra with Special Reference to Urinary Tract Infection.
Group
A: Eranda-Patra Kshara.
Group B:
Yavakshara.
Appropriate
Sampling Technique: Simple randomised sampling method by computerised
random technique will be done for 80 patients of age group 18 to 60
years.
The
subjects will be randomised in two study groups i.e., Group A and B. The time
and date of recruitment shall also be recorded in the enrolment log.
Follow up:
10th, 15th day.
Assessment
Criteria: The study will be strictly based on assessment of subjective
parameter by the grading them.
The data
obtained will be analyzed statistically.
Observation
and Results: Observation and results will be drawn according to assessment
criteria.
Discussion:
The observed phenomena will be discussed.
Conclusion:
Conclusion will be drawn strictly on basis of statistical analysis and will be
unbiased
Summary:
The research study will be summarized in brief.
Ethical Consideration: The study will be conducted in
accordance with ethical guidelines and inform consent from participant. |