CClinicalTrials.gg
Status unknownNCT05572268Updated Oct 7, 2022

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

A Phase 3 interventional study of to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection in Treatment Compliance, sponsored by Shifa Ul Mulk Memorial Hospital. Status unknown at 2 sites in Pakistan. Open to female participants aged 15 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Shifa Ul Mulk Memorial Hospital · Phase 3, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Aug 2021, registered Sep 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
15 Years to 70 Years
Sex
Female
01

Study 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
Read the 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.

02

Conditions studied

  • Treatment Compliance

Keywords

  • Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa
03

In context

Lead sponsor

Shifa Ul Mulk Memorial Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Drugto 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

    Also known as: Cranmax

06

What researchers measure

Primary outcomes

  1. Urine D/R

    To check the urinary infection

    Time frame: I week

Secondary outcomes

  1. Improvement in clinical symptoms

    Improvement in clinical symptoms such as burnining micturation

    Time frame: I week

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05572268
Lead sponsor
Shifa Ul Mulk Memorial Hospital
Responsible party
Dr. Hafiz Muhammad Asif (Chairperson Department of Eastern Medicine, Jinnah University, Shifa Ul Mulk Memorial Hospital) — Principal investigator
First posted
Oct 7, 2022
Start date
Aug 12, 2021
Primary completion
Aug 12, 2024 (estimated)
Completion
Aug 12, 2024 (estimated)
Last update
Oct 7, 2022

Study contacts

Halima Nazar, Ph.D
Contact
halimanazar76@gmail.com
03322889976
Misbah Ahmed, BEMS
principal investigator · Jinnah University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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