Evaluation of the effectiveness of Trachyspermum ammi hydro-alcoholic extract on indicators related to kidney stones (randomized double-blind clinical study)
Evaluation of efficacy of hydro-alcoholic extract as a supplementary natural medicine for relieving the symptoms of patients with kidney stones
Design
Clinical trial with control group, including parallel, double blind, randomized, in phase 2 on 100 patients. Rand function in Excel software was used for randomization.
Settings and conduct
Study would be done in Yalda clinic of Tehran University of Medical Sciences byrandomized and double-blind method. Patients would be placed in a group receiving common therapy plus Ajwain drop or a group receiving common therapy plus placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-70 year; Stone diameter less than 10 mm; Filling consent form.
Exclusion criteria: Pregnancy of Breastfeeding; Being a candidate for surgery or lithotripsy; Hypercholesterolemia; Concurrent therapy with anti-coagulants or anti-platelets; cirrhosis of the liver; Moderate to severe renal insufficiency.
Intervention groups
The first intervention group will receive tamsolosin, analgesic (NSAID and opioid if necessary), hydrochlorthiazide and pyridoxine plus drop containing Ajwain extract. The second intervention group will receive tamsolosin, analgesic (NSAID and opioid if necessary), hydrochlorthiazide and pyridoxine plus drop containing placebo.
Main outcome variables
Pain level based on Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N15
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Trachyspermum ammi hydro-alcoholic extract on indicators related to kidney stones (randomized double-blind clinical study)
Public title
Efficacy of trachyspermum ammi hydro-alcoholic extract on kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be between 18 to 70 years old
The diameter of the patints' stone must be less than 10 mm
Patient's informed consent to enter the study
Exclusion criteria:
Pregnant and lactating patients
Patient with hyperchloesterolemia
Patients that use anti-coagulant and anti-platelet medicine
Patients with liver cirrhosis
Patients with a stone diameter greater than 10 mm or a patient who is a candidate for lithotripsy or surgery
Patients with moderate to severe renal insufficiency
Patient dissatisfaction with continuing the study after enrollment
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the Random number generation plugin in Excel software, a table of random numbers from 1 to 100 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 50 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 100.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient will take the drug (intervention or comparison group) in closed envelopes that code
receives are categorized. Coding by one of the project collaborators It takes place and they are the doctor, the evaluator and the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Emam khomeini dospital of tehran University of Medical Sciences
Research Ethichs Committees of The Institute of Pharmaceutical Sciences- Tehran University Of Medica
Street address
16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-10-11, 1400/07/19
Ethics committee reference number
IR.TUMS.TIPS.REC.1400.196
Health conditions studied
1
Description of health condition studied
Kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Patient's pain
Timepoint
At the beginning of the study (before beginning of intervention) and 7, 14, 21 and 28 days after beginning of intervention
Method of measurement
Scoring patients based on Visual Analogue Scale from 0 to 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving a drop containing Ajwain extract (in which in each 30 drops are equivalent to one gram of plant fruit in the form of extract) which is taken orally in about 25 ml of lemon juice, in addition to one of the drug treatment protocols for kidney stones including tamsulosin (one 0.4 mg capsule per day), analgesic (non-steroidal anti-inflammatory and opioid if needed), hydrochlorothiazide (25 mg every 12 hours) and pyridoxine (40 mg tablets, once daily) For one month
Category
Treatment - Drugs
2
Description
Control group: Receiving an oral drop without active ingredient (containing one percent of a food colorant similar to the drug containing Ajwain) in the morning, noon and night, 30 drops in half a glass of lemon juice each time, plus one of the treatment protocols for kidney stones including tamsulosin (one 0.4 mg capsule daily), analgesics (NSAIDS and opioids if needed), hydrochlorothiazide tablet (25 mg every 12 hours) and pyridoxine tablet (40 mg, once daily) for one month