| CTRI Number |
CTRI/2025/03/081557 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Trikantakadya Ghrita in Mutrakrucchra with special reference to urine routine and microscopic examination. |
|
Scientific Title of Study
|
Singla Arm Clinical Study To Assess The Efficacy Of Trikantakadya Ghrita IN Mutrakrucchra With Special Reference To Urine Routine And Microscopic Examination |
| 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 Dadasaheb Namdev Raut |
| Designation |
PG Scholar Rognidan |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur, Department of Rognidan , Division
No 1 , Room no 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
9158406408 |
| Fax |
|
| Email |
dadashree1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauri Atmaram Mulik |
| Designation |
Professor And HOD |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur, Department of Rognidan , Division
No 1 , Room no 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
gaurimohite492@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri Atmaram Mulik |
| Designation |
Professor And HOD |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur, Department of Rognidan , Division
No 1 , Room no 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
gaurimohite492@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur, Tal Walwa Dist Sangli 415409 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Dadasaheb Namdev Raut |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur,Tal Walwa Dist Sangli 415409 Maharashtra |
| 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 Dadasaheb Namdev Raut |
LRP Ayurvedic Medical College And Hospital |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur, Department of Rognidan , Division
No 1 , Room no 1
Sangli
MAHARASHTRA |
9158406408
dadashree1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College 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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikantakadya Ghrita, Reference: Bhaishjya Ratnawali 34/56, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Guda), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between 20yrs – 60 years.
2 Patients of both gender.
3 All patients with symptoms of-
Mutrakrucchrata (dysuria)
Tvarata (Urgency)
Dourgandhya(foul smelling)
Sheetapurvak jwara (fever with Chills)
Bastishool(pain over suprapubic area)
Muhur mutrata (Frequency of micturition)
|
|
| ExclusionCriteria |
| Details |
1 Age group below 20 years and above 60 years.
2 K/C/O Diabetes mellitus.
3 Renal Failure.
4 Immune compromised Patients.
5 Urinary Tract Malignancy.
6 UTI due to any cause of bladder out-flow obstruction.
7 Pregnancy.
8 Any surgical intervention which leads to acute symptoms of UTI.
9 Not willing to give consent.
10 K/C/O- Acute Glomerulonephritis
11 K/C/O- Nephrotis Syndrome
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Trikantakadya Ghrita in Mutrakrucchra with special reference to urine routine and microscopic examination |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study the mutrakrucchra according to Ayurveda.
2 To study the urinary tract infection.
3 To study the Urine Routine & Microscopic Examination in details.
4 To study the effect of Trikantakadya Ghrita in Mutrakrucchra & lakshana & to study change in Urine Routine & Microscopic Examination.
|
18 Months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/03/2025 |
| 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="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
|
Urinary tract infection (UTI)
is the most common infection worldwide. In the developing countries,
incidence and prevalence of UTI would be similar owing to the relatively short
duration of illness experienced with ready access to healthcare services. In recent years Ayurvedic drugs are creating
interest in the people by clinically proven effects. Considering this the drug
“Trikantakadya ghrita” have been taken in management of Mutrakrucchra
which is described by Yogaratnakar in Mutrakrucchra adhyay. Trikantakadya ghrita contains Dravyas like Gokshur, Eranda, Mula, Shatavari, Kusha, Kasha,
Shara, Ikshu, Nala, Ervaru. All of those drugs have snigdha guna in common as well as vata
pittahara properties.
|