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

Phase 3

Recruiting

• Conditions: Treatment Compliance
• Interventions: Drug: to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection

• Registration Number: NCT05572268
• Lead Sponsor: Shifa Ul Mulk Memorial Hospital

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

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 Timeline

• Study Start: 2021-08-12
• Study First Submitted: 2022-09-28
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANSA Sachet	to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection	Ansa sachet having three APIs (Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa)
Cran Max Sachet	to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection	Cran Max is only having Vaccinium macrocarpon

Primary Outcome Measures

Name	Time	Method
Urine D/R	I week	To check the urinary infection

Secondary Outcome Measures

Name	Time	Method
Improvement in clinical symptoms	I week	Improvement in clinical symptoms such as burnining micturation

Trial Locations

Locations (2)

Misbah Ahmed; 🇵🇰 Karachi, Sindg, Pakistan

Pakistan; 🇵🇰 Karachi, Sindh, Pakistan