Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05572268
Status:
UNKNOWN
Last Update Posted:
2022-10-07
First Post:
2022-09-28
Brief Title:
EFFICACY OF ANSA Experimental Drug CRAN MAX Control Drug SACHET
Sponsor:
Shifa Ul Mulk Memorial Hospital
Organization:
Shifa Ul Mulk Memorial Hospital
Study Overview
Official Title:
IN VIVO AND IN VITRO COMPARATIVE STUDY ON EFFICACY OF ANSA Experimental Drug CRAN MAX Control Drug SACHET IN UNCOMPLICATED UTI
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions it aims to answer are
Hypothesis I ANSA is an effective therapy for uncomplicated UTI treatment and inhibits or kills Ecoli and other organisms in vitro and in vivo Null Hypothesis ANSA is not an effective therapy for uncomplicated UTI treatment and couldnt inhibit or kill Ecoli and other organisms in vitro and in vivo Hypothesis II Cran Max is an effective therapy for uncomplicated UTIs and inhibits or kills Ecoli and other organisms in vitro and in vivo Null Hypothesis Cran Max is not an effective therapy for uncomplicated UTI treatment and couldnt inhibit or kill Ecoli and other organisms in vitro and in vivo
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 questions it aims to answer are
Hypothesis I ANSA is an effective therapy for uncomplicated UTI treatment and inhibits or kills Ecoli and other organisms in vitro and in vivo Null Hypothesis ANSA is not an effective therapy for uncomplicated UTI treatment and couldnt inhibit or kill Ecoli and other organisms in vitro and in vivo Hypothesis II Cran Max is an effective therapy for uncomplicated UTIs and inhibits or kills Ecoli and other organisms in vitro and in vivo Null Hypothesis Cran Max is not an effective therapy for uncomplicated UTI treatment and couldnt inhibit or kill Ecoli 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 Ecoli 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 DMThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTI | OTHER | Jinnah University | None |