NCT05572268

Brief Summary

I This clinical trial aims to VIVO AND IN VITRO COMPARATIVE STUDY ON EFFICACY OF ANSA (experimental drug) \& CRAN MAX (control drug) SACHET IN UNCOMPLICATED UTI in females. The main question\[s\] it aims to answer are: • Hypothesis I ANSA is an effective therapy for uncomplicated UTI treatment and inhibits or kills E.coli and other organisms in vitro and in vivo Null Hypothesis ANSA is not an effective therapy for uncomplicated UTI treatment and couldn't inhibit or kill E.coli and other organisms in vitro and in vivo Hypothesis II Cran Max is an effective therapy for uncomplicated UTIs and inhibits or kills E.coli and other organisms in vitro and in vivo Null Hypothesis Cran Max is not an effective therapy for uncomplicated UTI treatment and couldn't inhibit or kill E.coli and other organisms in vitro and in vivo

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2021

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

September 28, 2022

Last Update Submit

October 6, 2022

Conditions

Treatment Compliance

Keywords

Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa

Outcome Measures

Primary Outcomes (1)

  • Urine D/R

    To check the urinary infection

    I week

Secondary Outcomes (1)

  • Improvement in clinical symptoms

    I week

Study Arms (2)

ANSA Sachet

EXPERIMENTAL

Ansa sachet having three APIs (Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa)

Drug: to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection

Cran Max Sachet

ACTIVE COMPARATOR

Cran Max is only having Vaccinium macrocarpon

Drug: to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection

Interventions

to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infectionDRUG

to evaluate the safety and efficacy of Cranmax for the treatment of UTi and control of Ecoli infection

Also known as: Cranmax
ANSA SachetCran Max Sachet

Eligibility Criteria

Age15 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients of age 15 to 70 years
  • Patient suffering from complain of burning micturition and will be diagnosed as a case of uncomplicated UTI by Urine D/R
  • Female patients from Karachi related to any discipline
  • All socioeconomic classes included in the study

You may not qualify if:

  • \. Males are not included in this study 2. Pregnant females 3. Patient having surgical history related to renal disorder are excluded 4. Patients with co-morbidities like diabetes, uncontrolled hypertension and liver disorder are excluded 5. Patient having any drug reaction from any of the study drug is excluded 6. Patient suffering from serious illness like encephalitis, coma, meningitis or head injury are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Misbah Ahmed

Karachi, Sindg, 74600, Pakistan

RECRUITING

Pakistan

Karachi, Sindh, 74600, Pakistan

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Misbah Ahmed, BEMS

    Jinnah University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Halima Nazar, Ph.D

CONTACT

03322889976halimanazar76@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson Department of Eastern Medicine, Jinnah University

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 7, 2022

Study Start

August 12, 2021

Primary Completion

August 12, 2024

Study Completion

August 12, 2024

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations

PA(2)