This single blind randomized clinical trial is conducted on 100 renal colic patients with ureteral stones less than 6 mm, from 23/09/2009 to 20/03/2010. After obtaining written consent all patients receive Hydrochlorothiazide (25 mg/day), Tamsulosin (0.4 mg/day), and analgesics and through simple randomization half of them also receive 150 ml/day Alhagi Pseudalhagi distillate from "Padina Natural Products, Mashhad" in 3 divided doses in addition to aforementioned drugs. All patients are visited again 2 weeks later and those with non-descent of stone, progressive hydronephrosis, or severe and unbearable symptoms are treated as medical treatment failures. Otherwise, the patients are followed for another 2 weeks and if at the end of the four-week period no stone is passed they will be categorized as no-stone-pass at the end of treatment. The stone expulsion rate and the time required for that will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804172134N1
Registration date:2009-12-29, 1388/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-12-29, 1388/10/08
Registrant information
Name
Ali Cyrus
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1888 1041
Email address
cyrus@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciencesو Deputy of Research
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Alhagi Pseudalhagi distillate on ureteral stone expulsion
Public title
The effect of Alhagi Pseudalhagi distillate on ureteral stone expulsion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having ureteral stones 6 mm, not severe hydronephrosis, age more than 20 yr and less than 60 yr, no signs of UTI or fever according to physical findings and urine analysis, no known renal diseases according to history and preliminary laboratory exams, no mandatory restriction of fluids due to an underlying disease, no bilateral ureteral stones, not having a single kidney, no known allergic reaction to Alhagi Pseudalhagi distillate or gum, not being pregnant, and body weight between 50 to 100 kg.
Exclusion criteria: patients' reluctance to continue participating in the study, no follow up visits, progressive hydronephrosis during follow up, occurrence of fever or UTI during follow up, repeated bouts of unbearable ureteral colics during follow up, allergic reactions or complications due to the treatment.
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Arak University of Medical Sciences
The control group receive Hydrochlorothiazide (25 mg/day), Tamsulosin (0.4 mg/day), Diclofenac sodium suppository (100 mg PRN), and Tramadol inj. (50 mg IM PRN).
Category
Treatment - Drugs
2
Description
The intervention group receive Hydrochlorothiazide tablets (25 mg/day), Tamsulosin capsules (0.4 mg/day), Diclofenac sodium suppository (100 mg PRN), Tramadol inj. (50 mg IM PRN), and 150 ml/day Alhagi Pseudalhagi distillate from "Padina Natural Products, Mashhad" in 3 divided doses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Vali Asr Hospital
Full name of responsible person
Dr. Ali Cyrus
Street address
Department of Surgery, Vali-Asr Hospital, Vali-Asr Square