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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210325050769N3

Enrollment

160

Registered

2026-05-05

Start date

2026-05-10

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional constipation. Constipation

Interventions

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 instructe

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with functional constipation based on Rome IV criteria Aged 18-60 years Filling consent form

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Ali Abyazi Heris

Bagheiat-allah University of Medical Sciences

yashar862@gmail.com+98 21 8804 0060

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026