EFFICACY OF ANSA (Experimental Drug) & CRAN MAX (Control Drug) SACHET

October 6, 2022 updated by: Dr. Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital

IN VIVO AND IN VITRO COMPARATIVE STUDY ON EFFICACY OF ANSA (Experimental Drug) & CRAN MAX (Control Drug) SACHET IN UNCOMPLICATED UTI

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, the emphasis is to evaluate the in vivo & in vitro efficacy of Ansa sachet having three APIs (Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa) in comparison with Cran max sachet in female patients having uncomplicated UTI. It is a single-blinded, randomized controlled trial. UTI (urinary tract infection) is mainly caused by E.coli and other associated organisms about 80% in females of fertile age and it occurs with less percentage in males. Uncommon recurrent UTIs is more prevalent in females than males. Post-menopausal women have higher rates of UTIs because of pelvic prolapse, lack of estrogen, loss of lactobacilli in the vaginal flora, increased peri-urethral colonization by Escherichia coli (E. coli), and a higher incidence of medical illnesses such as diabetes mellitus (DM).The microorganism that causes UTIs is similar, in most cases, to the sporadic infection. Most uro-pathogens from the rectal flora ascend to the bladder after colonizing in the peri urethral area and urethra. Keeping in mind that Helix Pharma designed ANSA in such a combination that it not only helps in the prevention of UTIs but also decreased recurrent UTIs as other APIs in ANSA have the capacity to normalize hormonal levels in females which is the basic cause of peri-menopausal and menopausal woman. The objective is to do a comparison of whether the Ansa sachet (experimental drug) or cran max sachet (control group) is a clinically good choice.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindg
      • Karachi, Sindg, Pakistan, 74600
    • Sindh
      • Karachi, Sindh, Pakistan, 74600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANSA Sachet
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
to evaluate the safety and efficacy of Cranmax for the treatment of UTi and control of Ecoli infection
Other Names:
  • Cranmax
Active Comparator: Cran Max Sachet
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
to evaluate the safety and efficacy of Cranmax for the treatment of UTi and control of Ecoli infection
Other Names:
  • Cranmax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine D/R
Time Frame: I week
To check the urinary infection
I week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in clinical symptoms
Time Frame: I week
Improvement in clinical symptoms such as burnining micturation
I week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa Ul Mulk Memorial Hospital

Investigators

  • Principal Investigator: Misbah Ahmed, BEMS, Jinnah University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2021

Primary Completion (Anticipated)

August 12, 2024

Study Completion (Anticipated)

August 12, 2024

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Misbah Ahmed
  • UTI (Other Identifier: Jinnah University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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