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Efficacy and complications of intragastric injection of botulinum toxin A in overweight and obese patients

Efficacy and complications of intragastric injection of botulinum toxin A in overweight and obese patients: A randomized, parallel-group clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250609066129N1
Enrollment
75
Registered
2025-06-14
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Overweight and obesity. Overweight and obesity

Interventions

Intervention 1: Botox group: After about 6 to 12 hours of fasting, the patient undergoes endoscopy under anesthesia and Botox is injected into the stomach. First, a vial of 500 units of BTX-A from the

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Body mass index equal to or greater than 30 kg/m2 and less than 39.9 Body mass index between 27 and 29.9 kg/m2 in the presence of comorbidities associated with abnormal weight who had not experienced at least five percent weight loss over a six-month period with lifestyle interventions

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Known history of allergy to botulinum toxin A History of angina pectoris, myocardial infarction, cerebral ischemia within the previous three months Liver and kidney failure Myopathy or neuromuscular disorder Peptic ulcer during endoscopy History of bariatric surgeries

Design outcomes

Primary

MeasureTime frame
Patient weight. Timepoint: Measurement of patient weight at the beginning of the study (before the start of the intervention) and 14, 28, 60, and 120 days after the intervention. Method of measurement: Digital scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Reza Najarzade

Mashhad University of Medical Sciences

dr.najarzade@yahoo.com+98 51 3843 4305

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026