| CTRI Number |
CTRI/2025/03/081939 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study of efficacy of yavakshaar in mutrakruccha( UTI) in children |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL
CLINICAL TRIAL TO STUDY THE EFFICACY OF YAVAKSHAAR IN
THE TREATMENT OF MUTRAKRUCCHA WITH SPECIAL REFERENCE TO URINARY TRACT INFECTION IN CHILDREN OF AGE GROUP 5-12 YEARS. |
| 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 Vinod Yadav |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital, Vazirabad Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital,Nanded, Vazirabad, Nanded. MAHARASHTRA 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
7506083752 |
| Fax |
|
| Email |
nehavy1410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini A Patil |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and Hospital, Vazirabad Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital,Nanded,Vazirabad, Nanded. 431601,Maharashtra.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9420247156 |
| Fax |
|
| Email |
organotech99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini A Patil |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and Hospital, Vazirabad Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital,Nanded,Vazirabad, Nanded. 431601,Maharashtra.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9420247156 |
| Fax |
|
| Email |
organotech99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Vazirabad,Nanded, 431601,Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr. Neha Vinod Yadav |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital, Vazirabad Nanded,431601, 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 Neha Yadav |
Government Ayurved Hospital Vazirabad, Nanded |
Department of
Kaumarbhritya Nanded
Maharashtra
Nanded
MAHARASHTRA
Nanded
MAHARASHTRA |
7506083752
nehavy1410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Ayurved College, Nanded |
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: Yavakshara, Reference: Bhaisjya Ratnavali chapter 34 verse 13, Route: Oral, Dosage Form: Kshara , Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Yavakshara will be adminisered in the syrup form to increase its palatability and to provide proper dilution | | 2 | Comparator Arm (Non Ayurveda) | | - | Oral administration of syrup containing Disodium Hydrogen Citrate | mainly used for the treatment of urinary tract infections, painful or difficult urination, kidney stones, urinary acidosis and gout. Disodium Hydrogen Citrate works by removing excess uric acid from the blood through urine. |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient irrespective of gender.
2. Age between 05 - 12 yrs.
3. Patient of Mutrakruchha fulfilling minimum two criteria as per diagnostic criteria.
4. Patients and parents willing to participate. |
|
| ExclusionCriteria |
| Details |
Patients having similar symptoms in the diseases other than UTI such as severe renalfunction impairment, carcinoma within urinary tract, gross hydronephrosis, pylonephrosis , severe obstruction uropathy, vesicle calculus.Patient suffering from major systemic illness like Hypertension, IHD, DM, Asthma, T.B.
etc.
Seriously ill patient of any disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To relive the urinary discomfort and other symptoms seen in mutrakruccha. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No any |
NO |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 about clinical trial to study the
efficacy of Yavakshara in Mutrakruccha (Urinary Tract Infection) in children of age
group 5 to 12 years.Yavakshara will be given twice a day for 7 days orally
and follow up on 3rd and 8th day. This study will be carried out
in two years of Pg course. Purpose of Study-Now a days Mutrakruccha is an
emerging problem because of unhygienic conditions and due to urine retention. this is one of the major cause of urine stasis which provides suitable condition for bacterial growth in urine. hence alkalization of urine is required to prevent bacterial growth in susceptible cases. Symptoms of Mutrakruccha are very disturbing for children due to irritation and urine discomfort . Hence I chose this topic for my study.
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