Acotiamide in functional dyspepsia

Phase 4

• Conditions: Health Condition 1: - Health Condition 2: K30- Functional dyspepsia

• Registration Number: CTRI/2022/08/044700
• Lead Sponsor: Payel Chakraborty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)No upper GI abnormality in upper GI endoscopy

2)Symptoms of dyspepsia for atleast 1 month

Exclusion Criteria

1.Patient with abnormal upper GI endoscopy.

2. Patient with alarm features (unintentional weight loss, persistent vomiting, dysphagia, hematemesis, melena, fever,

jaundice, or anemia),

3. Recent gastrointestinal surgery i.e. within 30 days.

4. Patients who show any of the following values at the baseline laboratory tests: severe anaemia, total leukocyte count <

3,000/mm3

, platelet count < 75,000/mm3

, AST and ALT � 100 IU/L, Creatinine � 1.5 mg/dL The blood tests should

have been done not more than 4 weeks prior to enrollment.

5.Treatment with non-steroidal anti-inflammatory drugs (NSAIDs), H2-blockers, proton pump inhibitors, prokinetic

agents, misoprostol or sucralfate 15 days prior to enrollment.

6. Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs.

7.History of hypersensitivity to either of the study drugs or closely allied drugs.

8. Women who are pregnant, lactating, or not willing to use adequate methods of contraception.

9.Any other condition which can lead the study investigators to consider the subject unsuitable for selection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified