Oral disintegrated tablet safety and tolerability in post-gastrectomy Indian patients
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
- Registration Number
- CTRI/2020/02/023450
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult patients more than or equal to 18 years, males and females with baseline haemoglobin 13 plus minus 1.9 g/dl, 12±1.9 g/dl respectively undergone total gastrectomy/subtotal gastrectomy for gastric cancer.
-Regular follow up as per study protocol.
-Able to provide Written informed consent
Exclusion Criteria
-Patients with other kinds of oral supplementation (multi-vitamins) post surgery in less than 4 weeks before randomisation.
-Males with Haemoglobin <11 g/dl and females with Haemoglobin < 10 g/dl.
-Patients with known hypersensitivity to the formulation
-Pregnant and lactating women
-Patients with severe neurological manifestations due to vitamin B12 deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point is to assess the drop in haemoglobin more than 2 g/dl in any armTimepoint: 4 years
- Secondary Outcome Measures
Name Time Method QOL assessment (FACT G questionnaire) <br/ ><br>CBC (Change in Hb and MCV, ANC and platelet count) <br/ ><br>Changes in the Iron studies/parameters including iron, ferritin, TIBC, transferring saturation. <br/ ><br>Timepoint: 4 years