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IRCT20231022059800N1 IRCT 2023-12-07 Mazandaran University of Medical Sciences the effect of an herbal Formula of Zizifus Jujuba on elderly functional constipation the effect of an herbal Formula of Zizifus Jujuba as complementary treatment of elderly functional constipation 2023-12-18 anticipated 60 Complete https://irct.ir/trial/73811 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study is conducted as an open label. Because the pharmaceutical forms are different and the two drugs are completely different in appearance, packaging, taste and way of consumption, Randomization description: The random block method will be used to allocate the samples to two groups. For this purpose, patients will receive number 1 to 60 according to their arrival. The randomization unit will be individually and by number with blocks of 4 people. The selection of the group type for each person will be done through random allocation 2 statistical software. In order to create a random sequence, codes A and B will be generated from the desired software, where code A will mean the application of the intervention group and code B will mean the application of the control group for each individual. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment. 3 Functional constipation of the elderly. Intervention 1: Intervention group: Intervention group: Jujube-based traditional medicine product, two tablespoons every 12 hours on an empty stomach with a glass of warm water, for 4 weeks. Intervention 2: Control group: A 20 gram sachet of Pidrolox powder is dissolved in 1 glass of water and taken 1 glass daily 2 hours after breakfast for 4 weeks. 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 There is no further information
public Assie Jokar
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 3117 a.jokar@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr taghavi.shirazi
Hassan Abad Square, Vahdat Eslami St., south side of Shahr Park, No. 847, beginning of Behesht St., Faculty of Iranian Medicine
Tehran Iran (Islamic Republic of) ۱۱۱۴۷۳۳۳۱۱ +98 21 5563 9667 taghavi.shirazi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age above 60 years, when the presence of functional constipation based on Roman IV indicators has been confirmed by a respected gastroenterologist. 60 years no limit Both History of allergy to jujube fruit or jujube product or pidrolox powder. Use of anti-Parkinson drugs, anti-psychotics, tricyclic antidepressants, anti-convulsants, anti-cholinergics, anti-spasms, anti-neoplastic, calcium blockers, 5HT antagonists, iron products.Alcohol and drug abuse. Suffering from severe mental illness and psychiatric disorders. Suffering from neurological diseases such as multiple sclerosis, Parkinson's, progressive systemic sclerosis, spinal cord injury, stroke. Suffering from a metabolic disease such as uncontrolled diabetes, hypothyroidism, hypercalcemia, pheochromocytoma, and any organic disease related to constipation, severe asthma, and bronchitis. Cardiac and hematological patients in case of taking drugs that cause constipation, including calcium blockers, furosemide, iron products, opioids. Inability to do physical activity and having special medical conditions such as inability to move. History of intestinal or stomach surgery, ostomy. History of malignancy and cancer. Kidney and liver failure. Endoscopy, colonoscopy, and radiology report in the last 5 years that has any abnormality and malignancy or IBD. Stool has abnormal OB, FBS, TFT, Ca. Viral gastroenteritis symptoms in the last two weeks. Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Jujube-based traditional medicine product, two tablespoons every 12 hours on an empty stomach with a glass of warm water, for 4 weeks. Control group: A 20 gram sachet of Pidrolox powder is dissolved in 1 glass of water and taken 1 glass daily 2 hours after breakfast for 4 weeks. Number of bowel movements per week. Timepoint: Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention. Method of measurement: Asking the patient through a questionnaire. Feeling of incomplete emptying after defecation. Timepoint: Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention. Method of measurement: Questionnaire and questions from the patient. Number of times of manual maneuver in defecation. Timepoint: Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention. Method of measurement: Questionnaire and questions from the patient. Consistency of stool. Timepoint: Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention. Method of measurement: Questionnaire and questions from the patient. The quality of life. Timepoint: Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention. Method of measurement: Quality of life questionnaire for functional constipation patients. Mazandaran University of Medical Sciences Approved 2023-10-24 Research Ethics Committee of Mazandaran University of Medical Sciences Ethic committee of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)