| CTRI Number |
CTRI/2024/11/076627 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Effect of Argvadhadi Kwatha and
Haritkyadi Kwatha in the management of Pittaja Mutrakruccra (Urinary Tract
Infection) in children |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative
Controlled Clinical Study to evaluate the efficacy of Argvadhadi Kwatha and
Haritkyadi Kwatha in the management of Pittaja Mutrakruccra (Urinary Tract
Infection) in children |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neerja Saini |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7988966973 |
| Fax |
|
| Email |
neerjasaini2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kataria |
| Designation |
Associate professor PG Dept. of Kaumarbhritya |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9034001230 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neerja sain |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Resea |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7988966973 |
| Fax |
|
| Email |
neerjasaini2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research umri road sector 8 Kurukshetra 136118 |
| Type of Sponsor |
Government 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 |
| Dr Neerja Saini |
Institute for Ayurved Studies and Research |
Room no 99 Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA |
7988966973
neerjasaini2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna AYUSH University |
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: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritkyadi Kwatha, Reference: Bhaishajya Ratnavali Mutrakrichra Chikitsa Prakrmana chapter 34 verse 67, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 16(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -mean dose for 6 to 14 year of age is mentioned and further dose will be calculated by clarks formula
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Argvadhadi Kwatha, Reference: Harita Samhita Tritya Sthana Mutrakrichra Adhyay chapter 19 verse 7, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 16(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -mean dose for 6 to 14 year of age is mentioned and further dose will be calculated by clarks formula |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents of children willing to participate in the research trial.
2. Children of age group 6-14 years. irrespective of Caste, Sex, Religion and socioeconomic status.
3. The patient having classical sign and symptoms of Pittaja Mutrakruccra (urinary tract infection). |
|
| ExclusionCriteria |
| Details |
1.Patients in age below 6 year and above 14 years.
2.Patient known case of Nephrotic syndrome, Nephritic syndrome, Phimosis, Renal calculi, Diabetes mellitus, malignancy and other systemic disorders.
3.Patient having congenital anomalies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
All the signs and symptoms of Pittaja mutrakruchra such
as Peeta Mutrapravruti, Sadaha Mutrapravruti, Saruja Mutrapravruti, Kricchra Mutrapravruti, Muhurmuhu Mutrapravruti, Sarakta Mutrapravruti, Fever and
objective parameter such as pus cells in urine, Urine Culture will be assessed |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of Pathya- Apathya will be assessed on 7th ,14th, 21th & 28th day.
Litrary data related to Pittaja Mutrakruccra (urinary tract infection) will be complied &
compare from different text of ayurveda & modern text.
|
7th ,14th, 21th & 28th day |
|
|
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)
|
14/12/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| 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
|
A randomized clinical trial has been designed to assess the efficacy of Argvadhadi Kwatha and
Haritkyadi Kwatha in the management of Pittaja Mutrakruccra (Urinary Tract
Infection) in children of age group 6 year to 14 year is
selected from O.P.D. of Kaumarbhritya Department of Institute for Ayurved Studies and Research. |