Urinary Tract InfectionsNCT04575493
Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection
A study testing Crano-cure and Ciprofloxacin 500 mg in people with Urinary Tract Infections, run by Islamia University of Bahawalpur at 2 sites in Pakistan.
Trial summary
The main objectives of the study are; to determine the efficacy of test drug Crano-cure for the treatment of urinary tract infection, to compare the effectiveness of Polyherbal formulation Crano-cure vs. Standard allopathic. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Crano-cure and Ciprofloxacin 500 mg
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesPakistan
- Study dates
- 5 Oct 2020to 30 Nov 2020
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15 to 60 years with symptomatic acute urinary tract infection.
- Willing to participate in the study
- Non-pregnant adult females.
- Clinical signs and symptoms of a UTI (e.g., dysuria, frequency, urgency to urinate, Burning sensations during urination, Hematuria, suprapubic pain) with onset of symptoms < 72 hours prior to study entry.
- One positive pre-treatment clean-catch midstream urine culture within 48 hours of enrollment in the study, defined as > 105 CFU/mL.
- Patients having all socioeconomic classes including lower, middle and higher.
- In-vitro susceptibility testing of the uropathogen to test and control drug.
Who cannot join
- • Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control. If an antimicrobial agent is to be studied for the treatment of UTI in pregnant women, this proposal should be justified, the risk/benefit expectations explained, and the issue presented to the division.
- Three or more episodes of acute uncomplicated UTI in the past 12 months.
- Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder.
- Patients with onset of symptoms 96 hours or more prior to entry.
- Patients with a temperature > 1010 F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection.
- Patients with known or suspected hypersensitivity to the test or control drug.
- Patients who received treatment with other antimicrobials within 48 hours prior to entry.
- Patient suffering in chronic illness Diabetes mellitus, chronic liver diseases
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Jalil Ur Rehman
Bahawalpur, Punajb, 63100
University College of Conventional Medicine
Bahawalpur, 63100
About this study
The main objectives of the study are; to determine the efficacy of test drug Crano-cure for the treatment of urinary tract infection, to compare the effectiveness of Polyherbal formulation Crano-cure vs. Standard allopathic. Antibacterial/ antibiotic (Ciprofloxacin 500 mg) in treatment of UTI, to assess the safety of trial drug.
Research literatures have revealed that Tribulus terrestris (Gokhro), Vaccinium macrocarpon (karonda), Cuminum cyminum (Zeera sufaid), Rheum emodi (Revand chini) and Piper cubeba (Kabab chini) are important therapeutic plants. Many pharmacological researches have been done on these plants. For instance, antioxidant, antiseptic, anti-microbial, anti-bacterial, anticancer etc. In the above claims and facts, the study is conducted to formulate and evaluate the polyherbal capsule and to find out the most effective combination having anti-bacterial activity.
Read the detailed description
A urinary tract infection (UTI) is the infection of kidney that affects urinary tract. It affects the urinary bladder (cystitis) and kidney (pyelonephritis). Symptoms of urinary bladder infection are painful urination, frequent micturation, and urinary incontinence. Symptoms of infection in kidney include pyrexia and lumber pain also in addition to symptoms of a lower urinary tract infection and rarely blood in the urine. In older age and in young adults, symptoms may be unclear or non-specific [1].
Urinary tract infections are grouped into two types; complicated and uncomplicated. In uncomplicated cases of urinary tract infections, the function of urinary tract system does not disturb. In complicated UTI, the normal function of UT system disturbs [2].
Uncomplicated UTI is usually caused by E. coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis Enterococcus spp. While complicated UTI is caused by Similar organisms which causes uncomplicated UTI Staphylococcus spp. Enterococcus spp. P. aeruginosa
Current studies on the prevalence of urinary tract infections approximately one third population of the world has been suffering from this disease. This disease causes Pyuria, burning urination, heamaturia, pyrexia, Vaginal itching, Offensive" smell and turbid urine, urinate frequent, urgency to urinate and suprapubic pain or pain in pelvis. It is not life-threatening disease. Different antibacterial/ antibiotics are available such as Co-trimaxazole, amoxicillin, nitrofurantoin, trimethoprim, combination of trimethoprim and sulfamethoxazole and quinolone antibiotics is taken as a choice for the treatment of UTI [3]. The antibacterial agents/ antibiotic available but they are limited in number, have adverse effects, resistance of bacteria to these agents and relapse of the UTI. In order to overcome the problem of less availability of drugs needed to treat urinary tract infection, with traditional medicine derived from medicinal plants. This encouraged the search for new and dynamic antibacterial agents from plant sources.
- Conditions
- Urinary Tract Infections
- Being tested
- Crano-cure, Ciprofloxacin 500 mg
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crano-cureDietary supplement
Research literatures have revealed that Tribulus terrestris (Gokhro), Vaccinium macrocarpon (karonda), Cuminum cyminum (Zeera sufaid), Rheum emodi (Revand chini) and Piper cubeba (Kabab chini) are important therapeutic plants. Many pharmacological researches have been done on these plants. For instance, antioxidant, antiseptic, anti-microbial, anti-bacterial, anticancer etc. In the above claims and facts, the study is conducted to formulate and evaluate the polyherbal capsule and to find out the most effective combination having anti-bacterial activity.
Ciprofloxacin 500 mgDrug
Being a standard drug as antibiotic and will be used in Control group.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | No of enrolled Pts. 102 Drug Cap. Crano-cure 500mg. Quantity 500 mg Bd Usage 1 cap Bd Duration of study 14 days Follow up 1st follow up after 2 weeks 2nd follow up after 4 weeks Receives: Dietary Supplement: Crano-cure |
| control group | Active comparator | No of enrolled Pts. 103 Drug Tab. Ciprofloxacin 500mg Quantity 500mg Bd Usage 1 Tab Bd Duration of study 14 days Follow up 1st follow up after 2 weeks 2nd follow up after 4 weeks Receives: Drug: Ciprofloxacin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Culture Examination
Urine Culture examination for
Escherichia coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start5 Oct 2020
- Primary completion30 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trials are designed to understand the nature of disease, its associated symptoms, and patient's response towards management. The study has aim to evaluate the effect of medical intervention with allopathic and herbal medicine to treat urinary tract infection. For this purpose, the patient suffering from urinary tract infection were examined and managed in different medical centers such as Shifa-ul-Mulk Memorial Hospital Hamdard University Karachi, Naseem ul Sehat Eastern Medicine Clinic Bahawalpur, Matab Hakeem Atta ur Rehman Siddique Lahore and khurshid Siddique Clinic Lahore.
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Collaborators
- Hamdard University
- Responsible party
- Principal investigator, Hafiz Abdul Sattar Hashmi, Islamia University of Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575493
- Sponsor's protocol ID
- EM-DP-14-001
- Status last verified
- Jun 2021
- First submitted
- 25 Sep 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ur Rehman J, Iqbal A, Asif HM, Hadi F, Ahmed K, Ahmed M, Sumreen L. Alternative Approaches for the Management of Urinary Tract Infection with Crano-cure: A Randomized Clinical Trial. Altern Ther Health Med. 2024 Jul;30(7):12-19.
PubMed 39110045
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT04575493
- Acronym / sponsor ID
- EM-DP-14-001
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Collaborators
- Hamdard University
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 5 Oct 2020 (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.
The main objectives of the study are; to determine the efficacy of test drug Crano-cure for the treatment of urinary tract infection, to compare the effectiveness of Polyherbal formulation Crano-cure vs. Standard allopathic. Antibacterial/ antibiotic (Ciprofloxacin 500 mg) in treatment of UTI, to assess the safety of trial drug.
Research literatures have revealed that Tribulus terrestris (Gokhro), Vaccinium macrocarpon (karonda), Cuminum cyminum (Zeera sufaid), Rheum emodi (Revand chini) and Piper cubeba (Kabab chini) are important therapeutic plants. Many pharmacological researches have been done on these plants. For instance, antioxidant, antiseptic, anti-microbial, anti-bacterial, anticancer etc. In the above claims and facts, the study is conducted to formulate and evaluate the polyherbal capsule and to find out the most effective combination having anti-bacterial activity.
Detailed description
A urinary tract infection (UTI) is the infection of kidney that affects urinary tract. It affects the urinary bladder (cystitis) and kidney (pyelonephritis). Symptoms of urinary bladder infection are painful urination, frequent micturation, and urinary incontinence. Symptoms of infection in kidney include pyrexia and lumber pain also in addition to symptoms of a lower urinary tract infection and rarely blood in the urine. In older age and in young adults, symptoms may be unclear or non-specific [1].
Urinary tract infections are grouped into two types; complicated and uncomplicated. In uncomplicated cases of urinary tract infections, the function of urinary tract system does not disturb. In complicated UTI, the normal function of UT system disturbs [2].
Uncomplicated UTI is usually caused by E. coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis Enterococcus spp. While complicated UTI is caused by Similar organisms which causes uncomplicated UTI Staphylococcus spp. Enterococcus spp. P. aeruginosa
Current studies on the prevalence of urinary tract infections approximately one third population of the world has been suffering from this disease. This disease causes Pyuria, burning urination, heamaturia, pyrexia, Vaginal itching, Offensive" smell and turbid urine, urinate frequent, urgency to urinate and suprapubic pain or pain in pelvis. It is not life-threatening disease. Different antibacterial/ antibiotics are available such as Co-trimaxazole, amoxicillin, nitrofurantoin, trimethoprim, combination of trimethoprim and sulfamethoxazole and quinolone antibiotics is taken as a choice for the treatment of UTI [3]. The antibacterial agents/ antibiotic available but they are limited in number, have adverse effects, resistance of bacteria to these agents and relapse of the UTI. In order to overcome the problem of less availability of drugs needed to treat urinary tract infection, with traditional medicine derived from medicinal plants. This encouraged the search for new and dynamic antibacterial agents from plant sources.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical trials are designed to understand the nature of disease, its associated symptoms, and patient's response towards management. The study has aim to evaluate the effect of medical intervention with allopathic and herbal medicine to treat urinary tract infection. For this purpose, the patient suffering from urinary tract infection were examined and managed in different medical centers such as Shifa-ul-Mulk Memorial Hospital Hamdard University Karachi, Naseem ul Sehat Eastern Medicine Clinic Bahawalpur, Matab Hakeem Atta ur Rehman Siddique Lahore and khurshid Siddique Clinic Lahore.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Dietary Supplement: Crano-cureNo of enrolled Pts. 102 Drug Cap. Crano-cure 500mg. Quantity 500 mg Bd Usage 1 cap Bd Duration of study 14 days Follow up 1st follow up after 2 weeks 2nd follow up after 4 weeks |
| control group | Active comparator | Drug: Ciprofloxacin 500 mgNo of enrolled Pts. 103 Drug Tab. Ciprofloxacin 500mg Quantity 500mg Bd Usage 1 Tab Bd Duration of study 14 days Follow up 1st follow up after 2 weeks 2nd follow up after 4 weeks |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 15 to 60 years with symptomatic acute urinary tract infection.
Key exclusion criteria (8 listed)
- • Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control. If an antimicrobial agent is to be studied for the treatment of UTI in pregnant women, this proposal should be justified, the risk/benefit expectations explained, and the issue presented to the division.
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 |
|---|---|---|
| Crano-cureResearch literatures have revealed that Tribulus terrestris (Gokhro), Vaccinium macrocarpon (karonda), Cuminum cyminum (Zeera sufaid), Rheum emodi (Revand chini) and Piper cubeba (Kabab chini) are important therapeutic plants. Many pharmacological researches have been done on these plants. For instance, antioxidant, antiseptic, anti-microbial, anti-bacterial, anticancer etc. In the above claims and facts, the study is conducted to formulate and evaluate the polyherbal capsule and to find out the most effective combination having anti-bacterial activity. | Dietary supplement | Test Group |
| Ciprofloxacin 500 mgBeing a standard drug as antibiotic and will be used in Control group. | Drug | control group |
Primary outcome
Urine Culture Examination
Time frame: 15 days
Urine Culture examination for Escherichia coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Derived from this study: PubMed 39110045Ur Rehman J, Iqbal A, Asif HM, Hadi F, Ahmed K, Ahmed M, Sumreen L. Alternative Approaches for the Management of Urinary Tract Infection with Crano-cure: A Randomized Clinical Trial. Altern Ther Health Med. 2024 Jul;30(7):12-19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crano-cure and Ciprofloxacin 500 mg in people with Urinary Tract Infections, run by Islamia University of Bahawalpur 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 24 Jun 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Culture Examination (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575493, which also lists 1 linked publication.
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 24 Jun 2021.