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IRCT20210325050769N3 IRCT 2026-05-05 Bagheiat-allah University of Medical Sciences Magnesium citrate in functional constipation Efficacy and safety of SAMANIK RELAX® (magnesium citrate) in the treatment of functional constipation: a randomized, double-blind, placebo-controlled clinical trial 2026-05-10 anticipated 160 Recruiting https://irct.ir/trial/89804 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized, placebo-controlled, parallel-group, double-blind clinical trial. Intervention duration is 28 days (one month). Follow-up includes daily phone calls for data recording in diaries and clinic visits at week 2 and week 4. Efficacy assessment is based on Rome IV criteria and Bristol Stool Form Scale, Randomization description: The study utilizes block randomization with blocks of four. The random sequence is generated using Microsoft Excel 2019 software via a custom module defined in the Visual Basic for Applications (VBA) environment. In this method, treatment blocks for the two groups (intervention and control) are randomly permuted (e.g., possible permutations for a block of 4 include AABB, ABAB, etc., with equal probability). The final randomization list is prepared by a person independent of the research team and placed in sealed envelopes. After recording patient details, the researcher randomly selects one envelope to assign the patient to either the intervention or control group, Blinding description: The study is designed as a double-blind trial. 1. Physical Appearance: The placebo is prepared as a powder with a color and taste (blueberry) similar to the active product, but without the active ingredient (Magnesium Citrate). The packaging, labeling, sachet color, and distribution boxes (two 28-sachet boxes) are identical for both groups, making it impossible to distinguish between the intervention and placebo visually. 2. Blinding of Patients and Physicians: Both the patients and the treating physician/researcher are unaware of the assigned intervention (SAMANIK RELAX® or placebo). Each patient is assigned a unique identification code by the physician, who remains blinded to the group allocation. 3. Blinding of Assessors: To assess stool consistency using the Bristol Stool Form Scale, patients send photos of their stool. These images are evaluated by a trained member of the research team who is strictly blinded to the patient's group assignment. 4. Blinding of Analysts: At the end of the study, only one team member, who was not involved in data collection or assessment, holds the key linking codes to group assignments. Prior to statistical analysis, this individual reclassifies the codes into Group A (Placebo) and Group B (SAMANIK RELAX®) and provides the coded dataset to the statistical analyst. Thus, the data analyst is also blinded to the group allocation. 3 Functional constipation. Intervention 1: The intervention group receives two sachets of SAMANIK RELAX® (containing magnesium citrate) daily, with each sachet providing 300 mg of elemental magnesium. Participants are instructed to dissolve each sachet in 200 ml of water and consume it separately in two divided doses (morning and evening). The use of other laxatives is prohibited during the study, except in cases of no bowel movement for more than 72 hours, where glycerin enema is permitted as a rescue medication and recorded. Intervention 2: The control group receives two placebo sachets daily, which are identical in appearance, color, packaging, and taste (blueberry) to the active product but contain no active ingredient (magnesium citrate). Participants in this group are instructed to consume the placebo exactly as the intervention group, dissolving each sachet in 200 ml of water in two divided doses (morning and evening). The monitoring protocol for adverse effects and restrictions on laxative use are identical to those in the intervention group. Yes - There is a plan to make this available What will be shared: All data can be shared after un-identification of individuals. When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic centers as well as to industry professionals. Conditions: Statistical analyzes on data are allowed for scientific and research use after obtaining permission from the project manager. Where to obtain: For data and documentation, refer to the Research Center for Gastroenterology and Liver Diseases and Dr. Mohammad Heiat. How to obtain: After receiving a written request from researchers... by the Baqiyatallah Research Center for Gastroenterology and Liver Disease and reviewing the application in the Research Council of the Research Center, the documents or data files will be delivered to the applicant after about 10 days. Comments:
public Mohammad Ali Abyazi Heris
Baqiyatallah Hospital, Mulla Sadra, Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915381 +98 21 8804 0060 yashar862@gmail.com Bagheiat-allah University of Medical Sciences scientific Mohammad Ali Abyazi Heris
Baqiyatallah Hospital, Mulla Sadra, Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915381 +98 21 8804 0060 yashar862@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with functional constipation based on Rome IV criteria Aged 18-60 years Filling consent form 18 years 60 years Both Pregnancy Lactation Organic gastrointestinal diseases (IBD, obstruction, tumors) History of gastric/bowel surgery Advanced renal/hepatic/cardiac diseases Concurrent use of laxatives or drugs affecting gut motility K59.0 Constipation Treatment - Drugs Treatment - Drugs The intervention group receives two sachets of SAMANIK RELAX® (containing magnesium citrate) daily, with each sachet providing 300 mg of elemental magnesium. Participants are instructed to dissolve each sachet in 200 ml of water and consume it separately in two divided doses (morning and evening). The use of other laxatives is prohibited during the study, except in cases of no bowel movement for more than 72 hours, where glycerin enema is permitted as a rescue medication and recorded. The control group receives two placebo sachets daily, which are identical in appearance, color, packaging, and taste (blueberry) to the active product but contain no active ingredient (magnesium citrate). Participants in this group are instructed to consume the placebo exactly as the intervention group, dissolving each sachet in 200 ml of water in two divided doses (morning and evening). The monitoring protocol for adverse effects and restrictions on laxative use are identical to those in the intervention group. Frequency of Spontaneous Bowel Movements (SBMs) per Week. Timepoint: Data is collected daily in the patient’s diary, and the weekly mean is calculated at the end of Week 2 and Week 4 (end of intervention). Method of measurement: Self-reported by participants in a daily diary and verified by researchers during follow-up visits (Weeks 2 and 4). Stool Consistency (Mean Bristol Stool Scale Score). Timepoint: Recorded daily in the diary; the weekly mean is calculated at the end of Week 2 and Week 4. Method of measurement: Participants record the score in their diary and submit one photo of their stool per week. The score is validated by a trained, blinded investigator who assesses the photos and diary entries independently of the treatment group. Time to Onset of Therapeutic Effect. Timepoint: Recorded daily in the diary; analyzed at the end of week 2 and week 4. Method of measurement: Calculated by identifying the date of the first successful spontaneous bowel movement or stool consistency improvement in the patient's daily logs. Adverse Events (Safety). Timepoint: Daily monitoring via reminder phone calls and diary entries; final assessment at in-person visits at the end of week 2 and week 4. Method of measurement: Type, severity, and duration of each adverse event are recorded. Severity is classified according to standard criteria (mild, moderate, severe). Samanik Salamat Gostar Pharmaceutical company Approved 2026-03-17 Ethics committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Mulla Sadra, Vanak Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)