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IRCT20221013056160N1 IRCT 2022-12-18 Applied Pharmaceutical Research Center, Tabriz University of Medical Sciences Investigating the effect of ointment prepared from Myrtus communis L. and Colchicum automnale L. for the treatment of grade I and II internal hemorrhoids Formulation, physicochemical evaluation and comparison of the effect of ointment prepared from Myrtus communis L. and Colchicum automnale L. with anti-hemorrhoid ointment on the symptoms of grade I and II internal hemorrhoids: a three-blind controlled clinical trial 2023-01-11 anticipated 60 Complete https://irct.ir/trial/66310 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule This method represents a large block for the entire sample volume, which means that the balance in the number of people It will be allocated to each of the groups at the end of the study. For this purpose, he first determined a total sample size, then randomly assigned a group of them to group A and the rest to group B, Blinding description: This three-blind randomized clinical trial will be conducted on 60 men and women with grade I and II hemorrhoids referring to health and treatment centers in Tabriz city. Eligible people will be assigned to two intervention and control groups using random block. In this study, the researcher, participant and clinical caregiver will not know the type of intervention received by the participants. 3 grade I and II internal hemorrhoids. Intervention 1: Intervention group: Intervention group: The intervention group includes 60 men and women with first and second degree hemorrhoids, referring to medical centers in Tabriz city, who will receive the herbal ointment. Intervention 2: Control group: The control group will include 60 men and women with first and second grade hemorrhoids in the same centers that will receive anti-hemorrhoid ointment or suppositories. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 12 months after the results are published To whom: Academic and scientific institutions Conditions: Mentioning the source should be used in all stages of their research and writing the article. Where to obtain: Dr. Hamed Hamishehkar Associate Professor of Faculty of Pharmacy in Tabriz Mobile phone: 00989143169252 Email: hamishehkar.hamed@gmail.com How to obtain: Immediately after the request, the effect will be arranged. Comments:
public Babak Abri Aghdam
Unit D, 5th Floor, Hakim Building, , Between Shariati and Taleghani Intersection, , Pastor New Street, Tabriz, Iran.
Tabriz Iran (Islamic Republic of) 0000000000 +98 41 3557 3306 babak756a@yahoo.com Tabriz University of Medical Sciences scientific Hamed Hamishehkar
Applied Pharmaceutical Research Center, Tabriz University of Medical Sciences, University Street, Tabriz.
Tabriz Iran (Islamic Republic of) 0000000000 +98 41 3336 3311 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Clients with first and second grade hemorrhoids who have been diagnosed with clinical symptoms and confirmation from a general surgeon. Patients should be in the age group of 17 to 70 years. Hemorrhoids of the clients are not caused by systemic diseases such as hypertension. Presence of hemorrhoid symptoms for at least more than 6 days Ability to read and write 17 years 70 years Both Use of systemic steroidal and non-steroidal anti-inflammatory drugs and analgesic treatments The use of systemic steroidal and non-steroidal anti-inflammatory drugs and analgesic and anti-hemorrhoid treatments (for one month before the study) and the use of anticoagulant drugs. The need for a surgical method to treat hemorrhoids (with the approval of a gastroenterologist and using clinical and colonoscopy tests) Patients with problems such as anorectal abscess, fistula, tuberculosis, herpes, varicella (confirmed by clinical tests or colonoscopy) Infectious inflammatory diseases of the digestive tract or colorectal cancer (according to the patient's statement) Previous use of laser or use of phlebotonic medicine to treat hemorrhoids one week before entering the study (according to the patient's statement) Participation in another interventional study Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: The intervention group includes 60 men and women with first and second degree hemorrhoids, referring to medical centers in Tabriz city, who will receive the herbal ointment. Control group: The control group will include 60 men and women with first and second grade hemorrhoids in the same centers that will receive anti-hemorrhoid ointment or suppositories. Investigating the amount of pain with the colo-rectal clinical treatment evaluation questionnaire. Timepoint: This questionnaire will be completed once before the start of the study and then in the first, second and fourth weeks, and once after the end of the intervention, in the eighth week after the start of the treatment. Method of measurement: (CORECTS= Colo-Rectal Evaluation of Clinical Therapeutics Scale). Investigating the amount of itching around the anus with the colorectal clinical treatment evaluation questionnaire. Timepoint: This questionnaire will be completed once before the start of the study and then in the first, second and fourth weeks, and once after the end of the intervention, in the eighth week after the start of the treatment. Method of measurement: (CORECTS= Colo-Rectal Evaluation of Clinical Therapeutics Scale). Investigating the amount of bleeding with the colo-rectal clinical treatment evaluation questionnaire. Timepoint: This questionnaire will be completed once before the start of the study and then in the first, second and fourth weeks, and once after the end of the intervention, in the eighth week after the start of the treatment. Method of measurement: (CORECTS= Colo-Rectal Evaluation of Clinical Therapeutics Scale). The questionnaire (WHOQOL-BREF) will be used to measure the quality of life. Timepoint: This questionnaire will be completed before the start of the study, in the fourth week after the intervention and in the eighth week after the start of the treatment. Method of measurement: Questionnaire (WHOQOL-BREF). Applied Pharmaceutical Research Center, Tabriz University of Medical Sciences Approved 2022-09-12 Ethics committee of TAbriz University of Medical Sciences Tabriz University, Building No. 2 of Medical Sciences, Research and Technology Vice-Chancellor, 3rd floor Tabriz East Azarbaijan Iran (Islamic Republic of)