| CTRI Number |
CTRI/2025/08/092475 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the effect of Pistacia lentiscus in treating urine infections caused by specific bacteria
|
|
Scientific Title of Study
|
Antibacterial activities of Pistacia lentiscus in patients with urinary tract infection (culture positive for selected bacteria): A Pilot Randomized Control Trial |
| 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. Swati |
| Designation |
Junior Resident, Department of Internal medicine |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Room no. 1073, 2nd floor, Block C, Department of Internal Medicine
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8218294237 |
| Fax |
|
| Email |
sainiswati029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Ravikant |
| Designation |
Professor and HOD, Internal medicine |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Room no. 1073, 2nd floor, Block C,
Department of Internal Medicine
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9870717859 |
| Fax |
|
| Email |
ravi.med@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Professor Ravikant |
| Designation |
Professor and HOD, Internal medicine |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Room no. 1073, 2nd floor, C block
Department of Internal Medicine
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9870717859 |
| Fax |
|
| Email |
ravi.med@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Self funded
Place- AIIMS Rishikesh, Virbhadra road, Rishikesh, Dehradun-249203,Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Dr Swati |
| Address |
Room no 1073 2nd floor Block C
Department of Internal Medicine AIIMS RISHIKESH
Uttarakhand
Pin 2492003
India |
| 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 Swati |
AIIMS RISHIKESH |
Room no. 1073, 2nd floor, Block C,
Department of Internal Medicine
AIIMS RISHIKESH,
Uttarakhand
Pin 2492003
India
Dehradun
UTTARANCHAL |
8218294237
sainiswati029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RISHIKESH |
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 |
Comparator - standard of care (Antibiotics according to culture sensitivity pattern) |
Comparator - standard of care (Antibiotics according to culture sensitivity pattern) |
| Intervention |
Pistacia lentiscus extracts |
Capsules of Pistacia lentiscus extracts along with standard of care ie antibiotic according to culture sensitivity pattern given for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of UTI having significant bacteriuria
2 Both male and female
3 Urine culture positive for Pseudomonas aeruginosa Escherichia coli Klebsiella spp Enterococcus spp |
|
| ExclusionCriteria |
| Details |
1 Patients with age less than or equal to 18yrs and more than or equal to 60 years
2 Patients with any known or clinically suspected structural urinary tract abnormalities
3 Urine culture having polymicrobial growth
4 Partially treated UTI
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in bacterial load in urine culture post treatment- urine routine microscopy and culture sensitivity reports |
Reduction in bacterial load in urine culture post treatment- urine routine microscopy and culture sensitivity reports at 4+/-1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical symptomatic releive
Biochemical inflammatory markers hsCRP ESR
Procalcitonin if indicated |
Clinical symptomatic releive
Biochemical inflammatory markers hsCRP ESR
Procalcitonin if indicated at 4 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
16/08/2025 |
| 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="0"
Months="8"
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 aims to evaluate the effectiveness of Pistacia lentiscus extract as an additional treatment in urinary tract infections caused by specific bacteria. It compares microbiological improvement between patients receiving standard care alone and those receiving Pistacia lentiscus extract along with standard treatment to assess its potential benefits. |