Treatment CompliancePhase 3NCT05572268
EFFICACY OF ANSA (Experimental Drug) & CRAN MAX (Control Drug) SACHET
A Phase 3 study of Treatment Compliance, run by Shifa Ul Mulk Memorial Hospital at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Treatment Compliance
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPakistan
- Study dates
- 12 Aug 2021to 12 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Misbah Ahmed
Karachi, Sindg, 74600
Misbah Ahmed, 03352142391, ahmedmisbah024@gmail.com
- Recruiting
Pakistan
Karachi, Sindh, 74600
Halima Nazar, 03322889976, halimanazar76@gmail.com
About this study
Official title: 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
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.
- Conditions
- Treatment Compliance
- Being tested
- to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection
- Keywords
- Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infectionDrug
Also called Cranmax
to evaluate the safety and efficacy of Cranmax for the treatment of UTi and control of Ecoli infection
| Study group | Role | What they receive |
|---|---|---|
| ANSA Sachet | Experimental | Ansa sachet having three APIs (Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa) Receives: 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 Receives: Drug: to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine D/R
To check the urinary infection
Measured: I week
Secondary outcomes (1)
Improvement in clinical symptoms
Improvement in clinical symptoms such as burnining micturation
Measured: I week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start12 Aug 2021
- Primary completion12 Aug 2024 (estimated)
- Study completion12 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Ul Mulk Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital
- Investigators
- Misbah Ahmed, BEMS, Principal investigator, Jinnah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572268
- Sponsor's protocol ID
- Misbah Ahmed
- Other IDs
- UTI
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN VIVO AND IN VITRO COMPARATIVE STUDY ON EFFICACY OF ANSA (Experimental Drug) & CRAN MAX (Control Drug) SACHET IN UNCOMPLICATED UTI
- ClinicalTrials.gov ID
- NCT05572268
- Acronym / sponsor ID
- Misbah Ahmed
- Conditions
- Treatment Compliance
- Keywords
- Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shifa Ul Mulk Memorial HospitalUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 12 Aug 2024 (estimated)
- Study completion
- 12 Aug 2024 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANSA Sachet | Experimental | Drug: to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infectionAnsa sachet having three APIs (Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa) |
| Cran Max Sachet | Active comparator | Drug: to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infectionCran Max is only having Vaccinium macrocarpon |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to evaluate the safety and efficacy of Ansa for the treatment of UTi and control of Ecoli infectionAlso: Cranmaxto evaluate the safety and efficacy of Cranmax for the treatment of UTi and control of Ecoli infection | Drug | ANSA Sachet, Cran Max Sachet |
Primary outcome
Urine D/R
Time frame: I week
To check the urinary infection
1 secondary outcome
Improvement in clinical symptoms
Time frame: I week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ahmed, BEMS principal investigator
Jinnah University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Treatment Compliance, run by Shifa Ul Mulk Memorial Hospital at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halima Nazar, Ph.D (03322889976, halimanazar76@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine D/R (time frame: I week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.