]>
IRCT20160306026938N15 IRCT 2022-12-07 Tehran University of Medical Sciences Efficacy of trachyspermum ammi hydro-alcoholic extract on kidney stone Evaluation of the effectiveness of Trachyspermum ammi hydro-alcoholic extract on indicators related to kidney stones (randomized double-blind clinical study) 2022-12-21 anticipated 100 Complete https://irct.ir/trial/54942 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Kidney stone. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information about the primary outcome can be shared When: Access started from 2023 To whom: Researchers working in academic and scientific institutions will be allowed to access the data Conditions: The data can be used for further research Where to obtain: Receiving data will be possible via Dr. Mehdi Vazirian by E-mail address of: mehdivazirian@gmial.com How to obtain: After receiving the E-mail and confirming the identity of the sender of the request, the data will be sent to the person for a maximum of one month. Comments:
public Mahdi vazirian
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6412 1223 vazirian_m@tums.ac.ir Tehran University of Medical Sciences scientific Mahdi vazirian
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6412 1223 vazirian_m@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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 N20.0 Calculus of kidney Treatment - Drugs Placebo 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 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 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. Tehran University of Medical Sciences Approved 2021-03-07 Ethics committee of Emam khomeini dospital of tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran Tehran Iran (Islamic Republic of) Approved 2021-10-11 Research Ethichs Committees of The Institute of Pharmaceutical Sciences- Tehran University Of Medica 16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219. Tehran Tehran Iran (Islamic Republic of)