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Oral disintegrated tablet safety and tolerability in post-gastrectomy Indian patients

An open label, prospective three-arm randomized, non-comparative study on efficacy and tolerability of orally disintegrating strip, oral tablets and intravenous administration of Vitamin B12, in post-gastrectomy Indian patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023450
Enrollment
180
Registered
2020-02-19
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: C169- Malignant neoplasm of stomach, unspecified

Interventions

Intervention1: Quicobal: Arm 1 : Tablet Quicobal( Mecobalamin orally disintegrating strip) Dose: 1500mcg Once daily Duration: for 4 years or reaching study end point Control Intervention1: Arm 2 Vit

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: -Patients with other kinds of oral supplementation (multi-vitamins) post surgery in less than 4 weeks before randomisation. -Males with Haemoglobin -Patients with known hypersensitivity to the formulation -Pregnant and lactating women -Patients with severe neurological manifestations due to vitamin B12 deficiency

Design outcomes

Primary

MeasureTime frame
Primary end point is to assess the drop in haemoglobin more than 2 g/dl in any armTimepoint: 4 years

Secondary

MeasureTime frame
QOL assessment (FACT G questionnaire) CBC (Change in Hb and MCV, ANC and platelet count) Changes in the Iron studies/parameters including iron, ferritin, TIBC, transferring saturation. Timepoint: 4 years

Countries

India

Contacts

Public ContactVikas Ostwal

Tata Memorial Hospital

dr.vikas.ostwal@gmail.com

Outcome results

None listed

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