| CTRI Number |
CTRI/2026/02/104121 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on an Ayurvedic Medicine (Gambhariyadi Vati) in urinary tract infection. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF
GAMBHARIYADI VATI IN THE MANAGEMENT OF LOWER URINARY TRACT
INFECTION (LUTI) WITH SPECIAL REFERENCE TO MUTRAKRICHHA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annpurna Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of PG And Ph.D. Studies in Shalya Tantra, Parul Institute of Ayurved, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9548233724 |
| Fax |
|
| Email |
annuvishnu1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Dean And Principal |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of PG And Ph.D. Studies in Shalya Tantra, Parul Institute of Ayurved, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
hemant.toshikhane@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annpurna Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of PG And Ph.D. Studies in Shalya Tantra, Parul Institute of Ayurved, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9548233724 |
| Fax |
|
| Email |
annuvishnu1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved,Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara Vadodara GUJARAT 391760 India |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
Department of PG And Ph.D. Studies in Shalya Tantra, Parul Institute of Ayurved, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara Vadodara GUJARAT 391760 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Annpurna Chauhan |
(1)Parul Ayurved Hospital, (2)Parul Sevashram Hospital |
OPD And IPD Wards Of Department Of Shalya Tantra, Department Of Kayachikitsa,Department Of Surgery, Department Of Urology. Department Of Medicine. Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara Vadodara GUJARAT 391760 India
Vadodara
GUJARAT |
9548233724
annuvishnu1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Parul institute of Ayurved |
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 | Drug | Classical | | (1) Medicine Name: Patalagarudi, Reference: Bhaisjya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ghambharyadi vati, Reference: Bhav Prakash Niganthu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18–70 years
Clinical symptoms of LUTI (burning micturition, frequency, urgency, dysuria)
Laboratory findings supporting LUTI (Urine routine and microscopic examination showing
Willing to give informed written consent. |
|
| ExclusionCriteria |
| Details |
Pyelonephritis
chronic kidney disease having LUTI
Pregnant and lactating women.
Patients with immunocompromised status (e.g., TB, chronic steroid use,
chemotherapy).
Patients with chronic systemic illnesses such as: Uncontrolled Diabetes Mellitus, Uncontrolled
Hypertension, Congestive Cardiac Failure.
Other Chronic Condition Having LUTI
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analytical study of Ghambhariyadi vati.
To assess the effect of Ghambhariyadi vati on signs and symptoms of LUTI.
|
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the therapeutic outcome of Gambhariyadi vati with Patalgarudi vati.
To evaluate changes in urine routine and micro findings before and after treatment.
|
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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
|
There is a growing burden of LUTIs and increasing antibiotic resistance No comparative clinical evaluation has been performed to assess the efficacy of Gambhariyadi vati and Patalgarudi tablets in Mutrakrichha. A comparative clinical trial will help in identifying the better formulation for LUTIs from an Ayurvedic perspective. Ayurveda formulations not only address the symptoms but also aim to strengthen mutravaha srotas, offering both therapeutic and preventive outcomes. |