| CTRI Number |
CTRI/2026/03/106644 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study Effect of Triphaladi Kalk in Mutrakriccha with special reference to urinary tract infection |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL TRIAL TO EVALUATE
THE EFFICACY OF TRIPHALADI KALK IN THE MANAGEMENT OF
MUTRAKRICHCHHA 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 Neha Jagannath Bhujbal |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8788829484 |
| Fax |
|
| Email |
nehabhujbal28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Sadanand Shiralkar |
| Designation |
Assistant Professor |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
MAHARASHTRA
416114
India
Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9011747576 |
| Fax |
|
| Email |
dr.abhijit7777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Jagannath Bhujbal |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
MAHARASHTRA
416114
India
Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8788829484 |
| Fax |
|
| Email |
nehabhujbal28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post graduate training and Research centre Kodoli taluka Panhala district kolhapur Pincode 416114 India
|
|
|
Primary Sponsor
|
| Name |
Dr Neha Jagannath Bhujbal |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala ,
Dist Kolhapur Kolhapur MAHARASHTRA 416114 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 Neha Jagannath Bhujbal |
Yashwant Dharmartha Rugnalay Kodoli |
Opd no 4
Shalyatantra
department 2nd floor
Yashwant Ayurvedic
College Post Graduate
Training and Research
Center, Kodoli
Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA |
8788829484
nehabhujbal28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli Tal-Panhala Dist - Kolhapur |
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: Triphaladi Kalk, Reference: 1) Yogratnakar, vidyotini hindi teeka, vaidya laxmipatishastri, uttarardh, 57/1,chaukhamba prakashan, 2024,page no 57 2) Bhavprakash, vidyotini teeka, bhishagratn shree brahmshankarmishra,Chikitsa sthan madhyam khand 35/41,Chaukhamba Sanskrit bhavan, Varanasi, 2020 page no 366, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Liquid Disodium Hydrogen Citrate , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Mutrakrichhra of age 18-40 years irrespective of gender,
occupation, socio-economic, etc
2) Patient diagnosed with symptoms
Muhurmuhu Mutrapravritti (Increased frequency of micturition)
Sashoola Mutrapravrutti (Pain during micturition)
Sadaha Mutrapravrutti (Burning Micturition)
3) Acute onset of Mutrakriccha (symptoms present less than 7 days |
|
| ExclusionCriteria |
| Details |
Subjects having surgical problems of UTI and its complications
Congenital, Neurological Anomalies of genitourinary system
K/C/O BPH/Cancer/TB/DM/HTN/STD/Impaired Renal Function and any
other systemic disease
Renal Calculi Pyelonephritis
Pregnant and Lactating Woman
Ashmarijanya, Shukrajanya, Purishaj and Shalyaj Mutrakrichhra
Patients having Foreign body (Urethra catheter, ureteral Dj stent) in urinary
tract |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Triphaladi Kalk in reducing the symptoms
of Mutrakriccha in patients aged 18–40 years over a period of 14 days. |
14 days BD before meal with water |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the effect of Triphaladi Kalk and Disodium Hydrogen Citrate
in symptoms of mutrakriccha.
2. To assess the effect of Triphaladi Kalk on objective parameters pus cell,
epithelial cell count, urine pH.
3. To evaluate the improvement in individual subjective symptoms
Mutradaha (burning micturition), Sashoola Mutrapravrutti (pain during
micturition) Muhurmuhu Mutrapravrutti (Increased frequency of
micturition).
4. To observe any adverse side effects during the treatment |
14 days BD after meal with water |
|
|
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)
|
01/04/2026 |
| 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 study is designed as a Randomized Open Controlled
Clinical Trial to evaluate the efficacy of Triphaladi Kalk in
the management of Mutrakriccha with special reference to Urinary
Tract Infection Study will be carried in OPD of Shalyatantra department of Yashwant Ayurvedic College PGT and RC Kodoli Assessment of signs and symptoms will be done at regular intervals. Result will be drawn according to statistical data |