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To compare the effects of two drugs named Acotiamide and Domperidon on the gastrointestinal symptom profile of patients with diabetes.

to compare the effects of acotiamide on symptom profile and gastric emptying time with domperidone in diabetic gastroparesis: a double blind randomised control trialâ?? - PGI GASTRO STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009173
Enrollment
60
Registered
2017-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Type 2 diabetic patients with minimum 5 year duration with symptoms of diabetic gastroparesis

Interventions

Intervention1: Tab.Domperidon 10mg tds or Tab.Acotiamide 100mg tds for diabetic gastroparesis: Consecutive adult patients with diabetes mellitus with cardinal symptoms of gastroparesis attending the G

Sponsors

DRUSHA DUTTA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Age above 18 years and below 65 years. •Documented history of diabetes mellitus (type 2) for a duration of minimum 5 years. •HbA1c 7-9gm% •Clinical evidence of gatroparesis with symptoms of post prandial fullness, early satiety, abdominal bloating, nausea, retching, vomiting of undigested food

Exclusion criteria

Exclusion criteria: Inability to obtain informed consent Pregnant or lactating women Patient with thyroid dydsfunction,renal failure ,parkinsons disease ,scleroderma Drug or alcohol abuse UGIE showing any mechanical obstruction Patient on GLP 1 analogues and pramlintides

Design outcomes

Primary

MeasureTime frame
to compare the effects of Tablet Acotiamide on Gastric emptying time in patients with diabetic gastroparesisTimepoint: 4week drug duration—

Secondary

MeasureTime frame
Gatric antral volume bu USG of gastric antrum and gall bladder ejection fraction will be calculated Timepoint: after 4weeks of treatment—

Countries

India

Contacts

Public ContactDRUSHA DUTTA

PGIMER,CHANDIGARH

ushadutta@gmail.com0172-2756610

Outcome results

None listed

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