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Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Crano-cure
Ciprofloxacin 500 mg
Sponsored by
Islamia University of Bahawalpur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Tract Infections

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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

Sites / Locations

  • Jalil Ur Rehman
  • University College of Conventional Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Urine Culture Examination
Urine Culture examination for Escherichia coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis

Secondary Outcome Measures

Full Information

First Posted
September 25, 2020
Last Updated
June 23, 2021
Sponsor
Islamia University of Bahawalpur
Collaborators
Hamdard University
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1. Study Identification

Unique Protocol Identification Number
NCT04575493
Brief Title
Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection
Official Title
Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamia University of Bahawalpur
Collaborators
Hamdard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Crano-cure
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin 500 mg
Intervention Description
Being a standard drug as antibiotic and will be used in Control group.
Primary Outcome Measure Information:
Title
Urine Culture Examination
Description
Urine Culture examination for Escherichia coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: • 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
Facility Information:
Facility Name
Jalil Ur Rehman
City
Bahawalpur
State/Province
Punajb
ZIP/Postal Code
63100
Country
Pakistan
Facility Name
University College of Conventional Medicine
City
Bahawalpur
ZIP/Postal Code
63100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection

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