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IRCT20210625051698N1 IRCT 2021-07-06 Karaj University of Medical Sciences The evaluation of effects of Daflon tablet on hemorrhoids The evaluation of effects of Daflon tablet on symptoms of hemorrhoids, its relapse and patients' duration of hospitalization 2021-08-23 anticipated 200 Complete https://irct.ir/trial/57149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are allocated into the intervention and control groups using permuted balance block randomization. The blocks are four. Using STATA software, random numbers are generated from 1 to 6. Another number is generated when the previous number is more than 6, without considering it. An individual who is not participated in design and conduction of study prepares the random numbers and put them in pockets with a five-digit serial number. All pockets with 5 digit numbers open after including a patient, and the patient is allocated to one of the two groups. In the case group patients are given Daflon 500mg per 12 hours for 4 weeks. In contrast, the control group patients are given placebo per 12 hours for 4 weeks, Blinding description: in this double blind study patients are not going to be aware of whether they have given placebo or Daflon. Moreover, the clinicians are not going to be aware of patients allocation. N/A Hemorrhoids. Intervention 1: Intervention group: Daflon group: After inclusion patients consume Daflon 500mg, which is produced Amin pharmaceutical company and comprise flavonoid agents by tablet each 12 hours (every day, twice a day) for 4 weeks (each participant consume 56 pills during the trial ). Intervention 2: Control group: Placebo group: Patients consume placebo, which is similar to Daflon in terms of taste and appearance each 12 hours (every day, twice a day) for 4 weeks (each participant consume 56 pills during the trial ). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not applicable.
public Mohsen Karimian
No 14 golestan3 ave , azimiye blvd,karaj town
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3255 8080 Mohsenkarimian494@gmail.com Karaj University of Medical Sciences scientific Mohsen Karimian
No 14 golestan3 ave , azimiye blvd,karaj town
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3255 8080 Mohsenkarimian494@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Patients over the age of 18 years old who were diagnosed with grade 3 or 4 of hemorrhoids based on a surgeons' physical exam and history taking 18 years no limit Both Does not have a history of previous treatment of hemorrhoids. Does not have a history of consumption or allergy to Daflon tablet. Does not have a history of renal failure or electrolytes imbalance. Does not have a serious underlying disease, including immunodeficiency disease, hyperparathyroidism, complete heart block, addison's disease, intestinal disorders, or malignancies. K64 Hemorrhoids and perianal venous thrombosis Treatment - Drugs Placebo Intervention group: Daflon group: After inclusion patients consume Daflon 500mg, which is produced Amin pharmaceutical company and comprise flavonoid agents by tablet each 12 hours (every day, twice a day) for 4 weeks (each participant consume 56 pills during the trial ). Control group: Placebo group: Patients consume placebo, which is similar to Daflon in terms of taste and appearance each 12 hours (every day, twice a day) for 4 weeks (each participant consume 56 pills during the trial ). Duration of improvements of sign and symptoms. Timepoint: 4 weeks after inclusion. Method of measurement: Duration of times that takes for patients for their signs to get improved. Severity of sign and symptoms. Timepoint: 4 weeks after inclusion. Method of measurement: The severity of symptoms are going to get reported by patients 4 weeks after inclusion based on visual Analogue scale. Relapse of sign and symptoms. Timepoint: 4 weeks after inclusion. Method of measurement: In case of resolution of symptoms in 4 weeks, patients report relapse of their symptoms. Karaj University of Medical Sciences Approved 2021-05-16 Ethics committee of Alborz University of Medical Sciences Deputy of research, Alborz university of medical sciences, Safarian street, Golshahr Karaj Alborz Iran (Islamic Republic of)