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Comparison of two drugs for digestive problems in diabetic patients

Comparison of the effects of Prucalopride and Itopride on gastric emptying in Diabetic Gastroparesis patients using gastrointestinal cardinal symptoms index (GCSI) score in a tertiary care hospital in North India: an open label randomised study

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099818
Enrollment
100
Registered
2025-12-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Itopiride: 150 mg once daily for 3 months Control Intervention1: Prucalopride: 2 mg once daily for 3 months

Sponsors

AIIMS Bathinda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 DM patients aged 18-65 years (males and female) known/diagnosed with gastrointestinal cardinal symptoms index (GCSI) score more than 10

Exclusion criteria

Exclusion criteria: Patients with GCSI score less than 10, Patients with age more than 18 and less than 65 years, Type 2 diabetic patients consuming drugs like anticholinergics, narcotic pain medicines, amylin analogues or antidepressants Patients with a history of gastric surgery or vagotomy, Patients having thyroid disorder (hypothyroidism), Patients having malignancy; undergoing chemotherapy or radiotherapy, Patients with history of gastroenterology surgery in past 6 months, Patient of Parkinsonism, Pregnant women

Design outcomes

Primary

MeasureTime frame
Changes in GCSI score before and after treatment with Prucalopride and ItoprideTimepoint: Baseline, After 1 month, After 2 months

Secondary

MeasureTime frame
Impact on Glycemic Control Changes in HbA1c levels and random blood sugar levels in diabetic gastroparesis patients treated with Prucalopride versus ItoprideTimepoint: Baseline, After 2 months

Countries

India

Contacts

Public ContactDr Rohit Raina

AIIMS

rohitraina103@yahoo.com9419188271

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026