| CTRI Number |
CTRI/2025/11/097910 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effecs of two drugs, Sharbat -e- Bazoori Moatadil and Nitrofurantoin in children with urinary tract infection. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to Evaluate the Efficacy of Sharbat -e- Bazoori Moatadil Versus Nitrofurantoin in Pediatric 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 |
Mo Azahar |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
Department of Ilmul Atfal, State Unani Medical College and Hospital, old GT Road Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9044735150 |
| Fax |
|
| Email |
drpedia003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mo Azahar |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
Department of Ilmul Atfal, State Unani Medical College and Hospital, old GT Road Himmatganj, Prayagraj
Department of Ilmul Atfal, State Unani Medical College and Hospital, old GT Road Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9044735150 |
| Fax |
|
| Email |
drpedia003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mo Azahar |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
Department of Ilmul Atfal, State Unani Medical College and Hospital, old GT Road Himmatganj, Allahabad
Department of Ilmul Atfal, State Unani Medical College and Hospital, old GT Road Himmatganj, Allahabad
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9044735150 |
| Fax |
|
| Email |
drpedia003@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital, old GT Road Himmatganj Allahabad 211016, uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and Hospital |
| Address |
Department of Ilmul Atfal, State Unani Medical College and Hospital Himmatganj, Allahabad 211016 |
| 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 |
| Mo Azahar |
OPD No.02,Department of Ilmul Atfal, State Unani Medical College and Hospital |
Old GT Road Himmatganj, Prayagraj, Pincode-211016
Allahabad
UTTAR PRADESH |
9044735150
drpedia003@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nitrofurantoin |
5–7 mg/kg/day orally in 4 divided doses for 7 days |
| Intervention |
Sharbat -e- Bazoori Moatadil |
Dose will be administered orally twice a day after meal for 7 days.
The dose will be calculated as a fraction of the adult dose of 50 ml-
2–6 yrs: 8.3 ml BD; 7–9 yrs: 12.5 ml BD; 10–15 yrs: 18.8 ml BD; 16–18 yrs: 25 ml BD. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders aged 3 to 18 years diagnosed with uncomplicated UTI.
Signs and symptoms consistent with UTI (e.g., fever, dysuria, frequency, suprapubic pain,) plus a positive urine analysis (pyuria equal or more than 5 WBC per HPF or positive leukocyte esterase per nitrite) or positive urine culture (more than 105 CFU per mL for midstream clean-catch or per local diagnostic cut-offs).
First episode or non-complicated recurrent UTI (equal or less than 2 episodes in past 12 months).
Patient’s guardian or parents willing to sign the informed consent form and follow the study protocol. |
|
| ExclusionCriteria |
| Details |
Complicated UTI ( e.g., pyelonephritis with systemic toxicity, urosepsis, prostatitis etc.)
Structural or functional urinary tract abnormality.
Recent antibiotic used ( Use of systemic antibiotics active against urinary pathogens within 48–72 hours prior to screening).
Exclude culture sensitive proven Nitrofurantoin resistant cases.
Patient is unsure about attending schedule regularly. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urine Analysis and Urine culture |
At Baseline
7th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in UTI symptoms |
At Baseline
3rd Day
7th DAY
14th DAY |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
19/12/2025 |
| 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="0"
Months="0"
Days="14" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shlt869@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 31-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Urinary tract infections UTIs are one of the most common bacterial infections in childhood affecting approximately 7.8percent of children There are different clinical symptoms of UTI such as cystitis pyelonephritis asymptomatic bacteriuria chronic and recurrent UTIs of which cystitis is the most frequent presentation affecting the urinary bladder If prompt treatment is not received the bacteria may continue to grow in the urinary tract and cause a kidney infection Between 75 and 95 percent of all cases of uncomplicated UTI are community acquired and are brought on by uropathogenic E. coli UPEC and Klebsiella spp. The most prevalent uropathogen was found to be E. coli followed by K. pneumoniae Symptoms are classified by severity Minor pyrexia adequate fluid intake minor dehydration and good treatment compliance are characteristics of mild UTIs Lower UTIs represent the majority of mild UTIs |