To Evaluate the Efficacy and Safety of Dipya Acidity Relief Tablet in the Management of chronic gastritis

To Evaluate Efficacy & safety of Dipya Acidity Relief Tablet in Management of chronic Gastritis. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074746

Enrollment

Registered

2024-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: K293- Chronic superficial gastritis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or Female Study Participants aged between 18 to 50 years, inclusive, at the time of signing the informed consent. 2. Completed the screening process within 3 days prior to randomization. 3. Study participant has understood and signed the informed consent form to participate in the study. 4. Study participant willing to be available for the entire study period and adhere to protocol requirements as evidenced by signing the informed consent document. 5. Study participants clinically diagnosed with chronic gastritis

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
1. Reduction in heartburn/epigastric discomfort 2. Reduction in acid reflux in 3.Relief from gas and bloating. 4. Relief from Nausea & vomiting 5. Improvement in appetite Timepoint: Visit 0: Screening Day 0 (-3 days) - Visit 1: Randomization in the study Day 1 - Visit 2: Day 15 - Visit 3: Day 30 - Visit 4: Day 45 - Visit 5: Day 60 (±3 days)	—

Secondary

Measure	Time frame
1. Changes in Laboratory Safety Parameters (CBC, LFT, KFT) from baseline to the end of the study. 2. Change in vital signs from baseline to the end of therapy. 3. Assessment of Adverse Events (AEs) & Serious Adverse Events (SAEs) in all enrolled Study administrationTimepoint: - Visit 0: Screening Day 0 (-3 days) - Visit 1: Randomization in the study Day 1 - Visit 2: Day 15 - Visit 3: Day 30 - Visit 4: Day 45 - Visit 5: Day 60 (±3 days)	—

Measure

Time frame

1. Changes in Laboratory Safety Parameters (CBC, LFT, KFT) from baseline to the end of the study. 2. Change in vital signs from baseline to the end of therapy. 3. Assessment of Adverse Events (AEs) & Serious Adverse Events (SAEs) in all enrolled Study administrationTimepoint: - Visit 0: Screening Day 0 (-3 days) - Visit 1: Randomization in the study Day 1 - Visit 2: Day 15 - Visit 3: Day 30 - Visit 4: Day 45 - Visit 5: Day 60 (±3 days)

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Countries

India

Contacts

Public ContactDrViraj Kelkar

Charak Pharma Pvt.Ltd

drsandeepmali@charak.com09702913695

Outcome results