| CTRI Number |
CTRI/2025/02/079921 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Darvyadi syrup for UTI relief in kids A Randomised Controlled Study |
|
Scientific Title of Study
|
A Randomized Controlled Clincal Study On Role Of Darvyadia Syrup In Pittaj Mutrakruchha WSR Urinary Tract Infection In Age Group Of 6 Years to 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 Siddhesh Rajendra Shete |
| Designation |
PG SCHOLAR |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of kaumarbhritya Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar
Hiravadi, Panchavati, Nashik, Maharashtra 420003,India
Nashik
MAHARASHTRA
420003
India |
| Phone |
7741042029 |
| Fax |
|
| Email |
sidshete98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
Hod and professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Ka |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar
Hiravadi, Panchavati, Nashik, Maharashtra 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
9224297523 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
Hod and professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Ka |
| Address |
Department of Kaumarbhritya,Ground Floor,Room No.4,Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar
Hiravadi, Panchavati, Nashik, Maharashtra 420003.
Nashik
MAHARASHTRA
420003
India |
| Phone |
9224297523 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kaumarbhritya Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar,hirawadi, panchavati, nashik, Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalay |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 420003 Nashik MAHARASHTRA 420003 |
| Type of Sponsor |
Other [Private Ayurved 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 Siddhesh Rajendra Shete |
Shree Saptashrungi Ayurved Mahavidyalaya, |
Department of Kaumarbhritya Ground floor, Room no 04,Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 420003.
Nashik
MAHARASHTRA |
7741042029
sidshete98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik |
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: PITTAJAMURCCA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi syrup ,, Reference: Yogratnakar mutrakruccha chikits, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Disodium hydrogen citrate, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Time of administration - 10ml PO TDS
Duration- 7days
Follow up-to 1,5,7 days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 6yrs to 12 yrs.
Patients irrespective of religion,sex,and
economicalstatus. Patients with sign and symptomsof
acute onset of Pittaj mutrakruchha. |
|
| ExclusionCriteria |
| Details |
Below the age of 6yrs and above the age of 12yrs. Congenital abnormalities.Patient having serious illness ,severe kidney diseases
Obstructive Pathologies Patient having infectious pathology
â— Chronic UTI pathology
urinaryneurologicalsymptoms
â— Any othersystemic illness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in sign and symptoms of pittaj mutrakruccha. |
Reduce in sign and symptoms of pittaj mutrakruccha after 1 week to 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of pittaj mutrkruccha |
7 days |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 3 |
|
Date of First Enrollment (India)
|
14/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/02/2025 |
| 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 Yet Recruiting |
| 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
|
1. Primary Objective
To study the effect of Darvyadi Syrup in Pittajmutrakrichha in age
group of 6yrs to 12yrs
2. Secondary Objective
1) To study the literature of pittaj mutrakrichha accordingto
classical Ayurveda texts. 2) To study the Urinary tract infection from modern literature. 3)To compare the effects of Darvyadi Syrup in Pittajmutrakrichha
against control drug Disodium Hydrogen citrate.
PARTICIPANTS 140 patients diagnosed with urinary tract infection meeting inclusion and exclusion criteria from OPD and IPD of department of kaumarbhritya of Shree Saptashrungi Medical College and Hospital Nashik.
Interventions 70 patients Darvyadi syrup: Administered according to standardized protocol. 70 patients Disodium hydrogen citrate : Administered according to standardized protocol. Primary Outcome : Reduce the sign and symptoms of pittaj mutrakruccha
Secondary Outcome: No recurrency of pittaj mutrakruccha Treatment
Duration : 7 Days Follow Up :1st , 5th , 7th Days
Data Analysis : Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervension on the primary and secondary outcomes.
Ethical Considerations : The study will be conducted in accordance with ethical guidelines and with informed consent from participents. |