Efficacy and safety of SAMANIK RELAX® (magnesium citrate) in the treatment of functional constipation: a randomized, double-blind, placebo-controlled clinical trial
To evaluate the efficacy and safety of SAMANIK RELAX® (magnesium citrate) in treating functional constipation
Design
Randomized, double-blind, placebo-controlled clinical trial with block randomization
Settings and conduct
Conducted at Baqiyatallah Hospital/University. Participants are randomized, undergo 4 weeks of intervention with weekly monitoring. Data collected via diaries and Bristol Stool Form Scale.
Participants/Inclusion and exclusion criteria
Inclusion: Ages 18–60, functional constipation diagnosed via Rome IV criteria. Exclusion: Pregnancy, organic gastrointestinal/renal diseases, concomitant laxative use
Intervention groups
Intervention group (SAMANIK RELAX®, two sachets daily) and Control group (placebo, two sachets daily)
Main outcome variables
1) Frequency of spontaneous bowel movements per week, 2) Mean Bristol Stool Scale score (stool consistency), 3) Incidence of adverse events (safety)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210325050769N3
Registration date:2026-05-05, 1405/02/15
Registration timing:prospective
Last update:2026-05-05, 1405/02/15
Update count:0
Registration date
2026-05-05, 1405/02/15
Registrant information
Name
Mohammad Heiat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2072
Email address
mohamad.heiat@bmsu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-10, 1405/02/20
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of SAMANIK RELAX® (magnesium citrate) in the treatment of functional constipation: a randomized, double-blind, placebo-controlled clinical trial
Public title
Magnesium citrate in functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with functional constipation based on Rome IV criteria
Aged 18-60 years
Filling consent form
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra, Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915381
Approval date
2026-03-17, 1404/12/26
Ethics committee reference number
IR.BMSU.REC.1405.015
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
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)
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.
Secondary outcomes
1
Description
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.
2
Description
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).
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Vanak sq. Mollasadra st. Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915381
Phone
+98 21 8126 2072
Fax
Email
Mohamad.heiat@bmsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after un-identification of individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic centers as well as to industry professionals.
Under which criteria data/document could be used
Statistical analyzes on data are allowed for scientific and research use after obtaining permission from the project manager.
From where data/document is obtainable
For data and documentation, refer to the Research Center for Gastroenterology and Liver Diseases and Dr. Mohammad Heiat.
What processes are involved for a request to access data/document
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.