| CTRI Number |
CTRI/2025/05/087829 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study on the Effectiveness of Gandhakadi Yoga and Disodium Hydrogen Citrate in Treating urinary tract infection
|
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF GANDHAKADI YOGA IN THE MANAGEMENT OF MUTRAKRUCCHA IN COMPARISON WITH DISODIUM HYDROGEN CITRATE 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 Payal Ashish Kela |
| Designation |
MS scholar Shalyatantra department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Nashik |
| Address |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia
Nashik
MAHARASHTRA
422003
India |
| Phone |
9284443710 |
| Fax |
|
| Email |
payalkela405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Professor Shalyatantra Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Nashik |
| Address |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Ashish Kela |
| Designation |
M.S. Scholar Shalyatantra Samanya Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia
Nashik
MAHARASHTRA
422003
India |
| Phone |
9284443710 |
| Fax |
|
| Email |
payalkela405@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra Samanya OPD no. 3 Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra Samanya Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, OPD no. 3.Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hirawadi
Panchavati. Nashik 422003 Maharashtra India
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrPayal Ashish Kela |
Department Of Shalyatanta,Shree Saptashrungi Ayurved Mahavidyalaya And Hospital |
Department of Shalyatantra Samanya OPD no 3 Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003 India
Nashik
MAHARASHTRA |
9284443710
payalkela405@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik Panchavati Nashik Maharashtra 422003 |
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: Gandhakadi yoga , Reference: Bhaishajya ratnavali 37/16, Route: Oral, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Disodium hydrogen citrate | 10 ml BD
21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinical diagnosis of UTI-associated Mutrakruccha |
|
| ExclusionCriteria |
| Details |
1)Pregnant or lactating women
2) Patients with known allergies or
Contraindications to the study medications
3) Patients with severe renal impairment or
Other serious comorbidities.
4) Patients having malignancy of any part of urinary tract.
5) Patients having sulphur allergy. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Gandhakadi Yoga in Mutrakruchhra with Special
reference to Urinary tract infection.
Urinary tract infection will be studied
Effect of gandhakadi yoga will be studied on given sample size |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Gandhakadi Yoga on comparison with disodium
hydrogen citrate in Mutrakruchhra with Special reference to Urinary tract
infection.
To study effect of disodium hydrogen citrate in UTI
To study effect of gandhakadi yoga in UTI
To study urinary tract infections |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/06/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Urinary Tract Infection (UTI), commonly presenting with symptoms like painful urination, frequency, and burning sensation, is often correlated with Mutrakruccha in Ayurveda. Conventional treatment includes antibiotics and urinary alkalizers such as disodium hydrogen citrate, which may lead to side effects or antibiotic resistance with repeated use. Ayurveda offers various formulations for managing Mutrakruccha, including Gandhakadi Yoga, which possesses antimicrobial, anti-inflammatory, and diuretic properties. This randomized controlled clinical trial aims to evaluate the efficacy and safety of Gandhakadi Yoga in the management of Mutrakruccha, in comparison with disodium hydrogen citrate. The study will assess symptomatic relief, improvement in urine analysis parameters, and recurrence rate over a defined treatment period. The sample size of this study will be 60 . The outcome of this study may support the integration of Ayurvedic formulations in UTI management, offering a natural and holistic alternative with potentially fewer side effects. Therefore the drug used in this trial can have an effective result in UTI |