]>
IRCT20191104045328N48 IRCT 2025-12-17 Arak University of Medical Sciences Effect of cinnamon on the improvement of urgency urinary incontinence Investigating the effect of adding cinnamon to toltrodine in the treatment of urinary incontinence in women 2025-12-11 anticipated 80 Complete https://irct.ir/trial/87780 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two intervention and placebo groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 4 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 4 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced, Blinding description: In this study, a capsule resembling the cinnamon capsule, made of starch and serving as a placebo, will be prepared and administered to the placebo group; therefore, the participants will not be aware of their group allocation. The medications will be prescribed by the attending physician, who is the principal supervisor. The designated assistant will collect the patients’ outcomes based on their medical record number or their name and surname and will provide them to the attending physician, who will then code the data. Therefore, the data collector, who is the resident responsible for the project, will remain blinded to the group assignments. 3 Urgency Urinary Incontinence. Intervention 1: Intervention group: In the intervention group, patients will receive a 1‑gram cinnamon capsule (Dr. Abidi Company) daily for 6 weeks. Intervention 2: Control group: In the placebo group, patients will receive a starch‑filled placebo capsule for 6 weeks. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2026/01/21 to 2029/01/21 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: Academic researchers and university faculty members, after initiating contact via message or email with the relevant supervisor, may request permission to access and use the data from Dr. Maryam Shekarpour. Dr. Maryam Shekarpour: Phone: +98‑918‑363‑4212 Email: Maryam_shokrpour@yahoo.com Address: Sina Rezaei Ashtiani Hospital, Basij Square, Sardasht, Arak, Iran How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Maryam Shokrpour
Sina Rezaei Ashtiani Hospital, Basij Square, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3601 Maryam_shokrpour@yahoo.com Arak University of Medical Sciences scientific Amir Almasi Hashian
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3383 8319 amiralmasi2007@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All women with urgency urinary incontinence Having informed consent to participate in the study 18 years 70 years Female Presence of systemic diseases such as chronic liver disorders, kidney disorders, and diabetes Presence of autoimmune diseases such as multiple sclerosis and neurological disorders Presence of cystocele and rectocele History of allergy to cinnamon and its derivatives N39.41 Urge incontinence Treatment - Drugs Placebo Intervention group: In the intervention group, patients will receive a 1‑gram cinnamon capsule (Dr. Abidi Company) daily for 6 weeks. Control group: In the placebo group, patients will receive a starch‑filled placebo capsule for 6 weeks. Daily urinary frequency. Timepoint: At baseline, 3 weeks, and 6 weeks after the intervention. Method of measurement: Asking the patient. Number of daily urgency urinary incontinence episodes. Timepoint: At baseline, 3 weeks, and 6 weeks after the intervention. Method of measurement: Asking the patient. Number of daily urinary urgency episodes. Timepoint: At baseline, 3 weeks, and 6 weeks after the intervention. Method of measurement: Asking the patient. Number of nocturia episodes per night. Timepoint: At baseline, 3 weeks, and 6 weeks after the intervention. Method of measurement: Asking the patient. Arak University of Medical Sciences Approved 2024-09-29 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)