A clinical Trial to study the efficacy, safety and tolerability of Levosulpiride 25mg + alprazolam 0.25mg tablets vs. Domperidone 10mg tablets in patient with functional dyspepsia.

A comparative, randomised, double blind; multicentric, clinical study to evulate the efficacy, safety and tolerability of levosulpiride 25mg + alprazolam 0.25mg tablets vs.domperidone tablets in patients with functional dyspepsia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/006116

Enrollment

100

Registered

2011-01-07

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: K30- Functional dyspepsia Health Condition 2: null- In patient with functional dyspepsia.

Interventions

Intervention1: Levosulpiride + alprazolam tablets: Three times daily for 4 weeks Control Intervention1: Domperidone tablets: Three times daily for 4 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Patients having a minimum of 1-month history of dyspepsia. Heartburn on 3 out of the last 7 days prior to screening or randomization. Written informed consent by patient participating in the trail.

Exclusion criteria

Exclusion criteria: Males or females, <18 or >75 years of age. Patients showing alarm features (unintentional weight loss, persistent vomiting, dysphagia, haematemesis, melaena, fever, jaundice, or anaemia), irritable bowel syndrome or serious concomitant disease. Patients with a history of gastrointestinal disease, recent gastrointestinal surgery i.e. within 30 days. Patients who had been treated with NSAIDs, ASA (>325 mg/day), H2-RAs, PPIs, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment. Pregnant, possibly pregnant, or lactating females. Participation in clinical trial with an investigation drug within 30 days proceeding day one of this study. Any condition that in the opinion of the investigator, does not justify the patient?s inclusion in the study. History of hypersensitivity to the study drug or similar class of drug.

Design outcomes

Primary

Measure	Time frame
Upper abdominal pain,Belching, Nausea (with or without vomiting), Bloating, Early satiety (the sensation of fullness after a very small amount of food).Timepoint: 1st week, 2nd week, 3rd week, 4th week	—

Secondary

Measure	Time frame
Overall response of clinical cure & overall global assessment.Timepoint: 4th week;Safety and tolerability of the test and reference product will be assessed depending on the improvement of following safety parameters: constipation, skin rash, dizziness, difficulty in breathing or speaking, fainting, irregular heartbeat, loss of balance or muscle control, swelling of face, hands or legs.Timepoint: 2nd week, 3rd week,4th week	—

Measure

Time frame

Overall response of clinical cure & overall global assessment.Timepoint: 4th week;Safety and tolerability of the test and reference product will be assessed depending on the improvement of following safety parameters: constipation, skin rash, dizziness, difficulty in breathing or speaking, fainting, irregular heartbeat, loss of balance or muscle control, swelling of face, hands or legs.Timepoint: 2nd week, 3rd week,4th week

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Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shailesh.singh@ajantapharma.com02266062111

Outcome results

None listed

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