| CTRI Number |
CTRI/2026/02/102752 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [clinical trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effectiveness of two Ayurvedic herbal treatments for relieving urinary tract infection symptoms in adults |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the effectiveness of Varividaryadi Kashaya and Duralabhadi Kashaya in lower 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. Aneesh.M |
| Designation |
Post Graduate Scholar |
| Affiliation |
Vishnu Ayurveda College |
| Address |
Third Semester PG Scholar
PG Department of Kayachikitsa
Vishnu Ayurveda College Shoranur
Vishnu Ayurveda College near Government press kulapully Pattambi Road Shoranur Kerala
679122
Palakkad
KERALA
679122
India |
| Phone |
8848431517 |
| Fax |
|
| Email |
draneeshkalarikkal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Midhun C K MD Ayu |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Ayurveda College |
| Address |
Associate Professor
PG Department of Kayachikitsa
Vishnu Ayurveda College Shoranur
Vishnu Ayurveda College near Government press kulapully Pattambi Road Shoranur Kerala
679122
Palakkad
KERALA
679122
India |
| Phone |
7902338877 |
| Fax |
|
| Email |
mithunisc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Midhun C K MD Ayu |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Ayurveda College |
| Address |
Associate Professor
PG Department of Kayachikitsa
Vishnu Ayurveda College Shoranur
Vishnu Ayurveda College near Government press kulapully Pattambi Road Shoranur Kerala
679122
Palakkad
KERALA
679122
India |
| Phone |
7902338877 |
| Fax |
|
| Email |
mithunisc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Ayurveda College
Near GOVT Press kulapully, Pattambi road,Shoranur,Palakkad district, kerala.PIN: 679122 |
|
|
Primary Sponsor
|
| Name |
Dr. Aneesh.M |
| Address |
Third Semester PG Scholar
Vishnu Ayurveda College
near Government Press Pattambi Road , Shoranur. PIN:679122 |
| 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 Aneesh M |
Vishnu Ayurveda Hospital Shoranur |
Vishnu Ayurveda Hospital,
Near Govt: Press, Kulapully, Pattambi road, Shoranur,Palakkad , Kerala. PIN: 679122
Palakkad
KERALA |
8848431517
draneeshkalarikkal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VISHNU AYURVEDA COLLEGE |
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: Duralabhadi kashaya, Reference: Bhaisajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sita ( 6gm)), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varividaryadi kashaya, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Yellow coloured urine,Dysuria,Increased frequency of micturition, Burning micturition, Urgency of micturition,Stranguria, Nocturia, Suprapubic discomfort
4 or more above symptoms will be selected for study. |
|
| ExclusionCriteria |
| Details |
High grade fever,Pregnancy and lactation, Diabetes mellitus, BPH, Urinary Calculi, PID, Foreign body in the urinary tract, Instrumentation of urinary tract,Pyelonephritis, Hydronephrosis, Sepsis, Chronic renal failure, Alcoholism, Acute UTI due to BPH or Urinary calculi |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in clinical symptoms of lower urinary tract infection |
Baseline, 2 weeks, 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms, comparative efficacy of both kashayas & safety profile of the intervention |
Baseline, 2 weeks, 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/02/2026 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [draneeshkalarikkal@gmail.com].
- For how long will this data be available start date provided 01-01-2029 and end date provided 31-12-2030?
Response (Others) - 2 years
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Lower Urinary Tract Infection (LUTI) is a common clinical condition characterized by dysuria, burning micturition, increased frequency, urgency, and suprapubic discomfort. In Ayurveda, these features closely resemble Pittaja Mutrakrichra. Although antibiotics are the mainstay of modern management, issues such as recurrence, resistance, and adverse effects necessitate safer and effective alternatives. The present study is a comparative interventional clinical trial aimed at evaluating the effectiveness of Varividaryadi Kashaya and Duralabhadi Kashaya, two classical Ayurvedic formulations indicated in Mutrakrichra. A total of 52 patients aged 18–50 years, fulfilling the diagnostic and inclusion criteria of Lower Urinary Tract Infection, will be randomly allocated into two groups of 26 each. Group A will receive Varividaryadi Kashaya and Group B will receive Duralabhadi Kashaya, both administered orally at a dose of 48 ml twice daily for 15 days, one hour before food. Assessment will be done on the 0th day, 16th day, and 21st day using both subjective parameters (clinical symptoms and Pittaja Mutrakrichra lakshanas) and objective parameters (urine routine microscopic examination). The outcomes will be statistically analyzed to compare the therapeutic efficacy of both interventions. This study aims to scientifically validate classical Ayurvedic formulations and identify a safe, effective, and economical treatment option for the management of Lower Urinary Tract Infection. |