| CTRI Number |
CTRI/2025/07/090924 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral administration of medicated Ayurveda preparation in treating urine infection in children |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Vari vidaryadi Kashaya in the management of Pittaja Mutrakrichra |
| 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 Arsha KP |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Kaumarabhrithya
Alvas Ayurveda Medical College and Hospital
Vidyagiri Moodubidire
Dakshina Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7736840858 |
| Fax |
|
| Email |
arshakp1098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Kaumarabhrithya
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Kaumarabhrithya
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
574227 |
|
|
Primary Sponsor
|
| Name |
Dr Arsha KP |
| Address |
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
574227 |
| 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 Arsha KP |
Alvas Ayurveda Medical College and Hospital |
Department of Kaumarabhrithya
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
574227
Dakshina Kannada
KARNATAKA |
7736840858
arshakp1098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N30-N39||Other diseases of the urinary system. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Kashaya, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vari vidaryadi Kashaya, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of sex between age group of 6 to 16 years
Patients fulfilling the diagnostic criteria of Pittaja Mutrakrichra
Symptoms less than 1 week duration |
|
| ExclusionCriteria |
| Details |
A child having UTI associated with surgical intervention and instrumentation
Child who is not accepting orally and suffering with any serious systemic illness eg septicemia meningitis severe dehydration shock persistent vomiting severe abdominal pain fever
Recurrent UTI with congenital kidney diseases pyelonephritis renal failure hematuria nephrotic syndrome vesicouteric reflex enuresis phimosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Vari vidaryadi kashaya in the management of pittaja mutrakrichra |
Before treatment
on 3rd day
on 7th day
on 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective parameters are assessed
Pus cells/ hpf
Epithelial cells/ hpf
RBC / hpf |
Before treatment
on 3rd day
on 7th day
on 14th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is randomized parallel group actively controlled comparative clinical study with Haritakyadi kashaya as standard drug and Vari vidaryadi kashaya as interventional drug which is given orally in the dosage of average 10 ml twice a day before food for a period of 7 days The study will be conducted on subjects having pittaja mutrakrichra belonging to the age group of 6 to 16 years who has given written and verbal consent by parents for undergoing clinical study The study will be conducting in Alvas Ayurveda Medical College and Hospital Moodubidire Interventional period of the study is 14 days and assessment will be done before treatment, on 3rd, 7th and 14th day |