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IRCT20141011019489N3 IRCT 2020-04-20 Shiraz University of Medical Sciences Effect of a natural cream on hemorrhoids in comparison with the conventional ointment Effect of a natural cream on hemorrhoids in comparison with conventional anti-hemorrhoid ointment: A double-blind controlled trial 2018-09-22 anticipated 80 Complete https://irct.ir/trial/45941 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use two variables to remove the effect of confounding factors: age and weight. In this method, the effect of the abovementioned two variables is controlled via analysis of variance. So, the effect of the independent variable (drug) on the dependent variable will be determined. To control age and weight we use randomized block design, i.e. quadratic blocks for weight and binary blocks for age. According to that, the samples will be allocated into A and B groups, Blinding description: The main researcher does not have any contact with the participants. The gastroenterologist only visits the participants and fills out the checklists. So, he will be kept unaware of the allocation into A or B groups. Moreover, the participants and the pharmacy technician who renders the ointments do not recognize the tubes (A or B) belonging to which group (drug or control). All tubes are the same form. 3 Condition 1: Hemorrhoid. Condition 2: Hemorrhoid. Intervention 1: Intervention group: Herbal cream containing the extract of oleaster, wild leek and camomile, and the essence of common myrtle. Route of administration and dose: Locally one gram on the anal region by a special applicator twice daily for 14 days. Manufacturer: Barij Essence Pharmaceutical Company. Intervention 2: Control group: Anti-hemorrhoid ointment (containing lidocaine 5 grams+Hydrocortisone Acetate 0.275 grams+ Aluminium sub-acetate 3.5 grams+ Zinc oxide 18 grams%). Route of administration: Locally on the anal region by a special applicator twice daily for 14 days. Manufacturer: Aburaihan Pharmaceutical Company/Barij Essence Pharmaceutical Company. An edible green color is used for the placebo to change the color similar to the drug. Yes - There is a plan to make this available What will be shared: The publication of data is restricted on demographic information and values obtained from the diagnostic checklist for hemorrhoids. This data will be published unrecognizably in the form of scientific articles in authentic journals. When: From March 2021 to March 2022 To whom: All audiences Conditions: The data can be used for similar researches under the prohibition of plagiarism Where to obtain: The data is available online for all audiences How to obtain: There is no process for obtaining information Comments:
public Mohammad Ebrahim Zohalinezhad
Zand St.
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3208 4241 zohalinm@sums.ac.ir Shiraz University of Medical Sciences scientific Meysam Shirzad
No. 25 Sarparast Ave., Taleqani St.
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 shirzad@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age: 18 and more Hemorrhoid Grade 1,2 18 years no limit Both Any types of malignancy Hypertension Hepatic or renal failure Diabetes mellitus K64.0 K64.1 First degree hemorrhoids Second degree hemorrhoids Treatment - Drugs Placebo Intervention group: Herbal cream containing the extract of oleaster, wild leek and camomile, and the essence of common myrtle. Route of administration and dose: Locally one gram on the anal region by a special applicator twice daily for 14 days. Manufacturer: Barij Essence Pharmaceutical Company Control group: Anti-hemorrhoid ointment (containing lidocaine 5 grams+Hydrocortisone Acetate 0.275 grams+ Aluminium sub-acetate 3.5 grams+ Zinc oxide 18 grams%). Route of administration: Locally on the anal region by a special applicator twice daily for 14 days. Manufacturer: Aburaihan Pharmaceutical Company/Barij Essence Pharmaceutical Company. An edible green color is used for the placebo to change the color similar to the drug. Manifestations of hemorrhoid. Timepoint: The onset of the intervention, 2 weeks later, 6 weeks later. Method of measurement: A checklist for hemorrhoid manifestations including 1- Anal pain (VAS zero to 10) 2- Difficulty in defecation (VAS zero to 10) 3- Bleeding severity (4-point Likert) 4- Anal pruritus (4-point Likert) 5- Anal burning (4-point Likert) 6- Subjective general improvement (percent). Barij essence pharmaceutical company Approved 2019-03-09 Ethics committee of Shiraz University of Medical Sciences 6th Floor, Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)