Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection

Sponsor

Islamia University of Bahawalpur (Other)

Overall Status

Completed

CT.gov ID

NCT04575493

Collaborator

Hamdard University (Other)

205

Enrollment

Locations

Arms

1.8

Actual Duration (Months)

102.5

Patients Per Site

55.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Dietary Supplement: Crano-cure Drug: Ciprofloxacin 500 mg	N/A

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

Study Type:

Interventional

Actual Enrollment :

205 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection

Actual Study Start Date :

Oct 5, 2020

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Group 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	Dietary Supplement: Crano-cure 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.
Active Comparator: control group 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	Drug: Ciprofloxacin 500 mg Being a standard drug as antibiotic and will be used in Control group.

Arm

Intervention/Treatment

Experimental: Test Group

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

Dietary Supplement: Crano-cure

Active Comparator: control group

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

Drug: Ciprofloxacin 500 mg

Being a standard drug as antibiotic and will be used in Control group.

Outcome Measures

Primary Outcome Measures

Urine Culture Examination [15 days]
Urine Culture examination for Escherichia coli Staphylococcus saprophyticus Klebsiella pneumonia Proteus mirabilis

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jalil Ur Rehman	Bahawalpur	Punajb	Pakistan	63100
2	University College of Conventional Medicine	Bahawalpur		Pakistan	63100

Sponsors and Collaborators

Islamia University of Bahawalpur
Hamdard University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hafiz Abdul Sattar Hashmi, Principal Investigator, Islamia University of Bahawalpur

ClinicalTrials.gov Identifier:

NCT04575493

Other Study ID Numbers:

EM-DP-14-001

First Posted:

Oct 5, 2020

Last Update Posted:

Jun 24, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Urinary Tract Infections

Ciprofloxacin

Study Results

No Results Posted as of Jun 24, 2021