Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection

NCT04575493 | Completed DMC

• 1 other identifier: EM-DP-14-001
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Urine Culture Examination

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

  15 days

Study Arms (2)

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

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

Drug: Ciprofloxacin 500 mg

Interventions

Crano-cure DIETARY_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.

Test Group

Ciprofloxacin 500 mg DRUG

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

control group

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Islamia University of Bahawalpur: lead
• Hamdard University: collaborator

Study Sites (2)

Jalil Ur Rehman

Bahawalpur, Punajb, 63100, Pakistan

Location

University College of Conventional Medicine

Bahawalpur, 63100, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 39110045 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 5, 2020
• Study Start: October 5, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)