L-Arginine Role for Stone Lower Ureter : A Randomized Control Study

NCT06753526 | Completed Phase 4 FDA Drug

• 1 other identifier: Soh-Med-23-05-09PD
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effects of L-Arginine 1000mg once daily as a medical expulsive therapy (MET) for lower ureter stones.

Conditions

Stone Lower Ureter

Keywords

stone; medical expulsive therapy

Outcome Measures

Primary Outcomes (4)

• Spontaneous stone expulsion rates (SER)

  detect the rate at which stone pass from the ureter

  From 1st renal colic till the time of stone pass or for four weeks

• Stone expulsion time

  time at which stone pass

  From 1st renal colic till the time of stone pass or for four weeks

• Number of daily colic episodes

  number of renal colic attack

  number of colicky attack From 1st renal colic till the time of stone pass or for four weeks

• Total required analgesic dosage

  Total required analgesic dosage

  From 1st renal colic till the time of stone pass or for four weeks

Study Arms (3)

Group I

PLACEBO COMPARATOR

about 53 patient, received NSAIDs

Drug: NSAID

Group II

ACTIVE COMPARATOR

about 53 patients received L-arginine 1000 mg once daily

Drug: L-Arginine, 500 Mg Oral Capsule

group III

ACTIVE COMPARATOR

included 51 patients who received Tamsulosin 0.4 mg once daily.

Drug: Tamsulosin 0.4 mg QD

Interventions

NSAID DRUG

For 1st group of patients

Group I

L-Arginine, 500 Mg Oral Capsule DRUG

group 2by twice dose

Group II

Tamsulosin 0.4 mg QD DRUG

group 3 by once per day

group III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old, ureter stones in size between 4 and 10 mm, single stone

You may not qualify if:

• Acute azotemia, stones larger than 10 mm, solitary kidney, symptomatic urinary system infection, impacted status, severe hydronephrosis, multiple or bilateral stones, pregnancy, anatomic urinary system abnormalities, benign prostate hyperplasia.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine, Sohag University

Sohag, 82511, Egypt

Location

Related Links

• most papper used

MeSH Terms

Conditions

Calculi

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Arginine; Tamsulosin

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology at faculty of medicine ,sohag university

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 31, 2024
• Study Start: July 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 31, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)