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Prevention of mucositis with Calphorinz solution for patients undergoing transplantation.

A randomized trial comparing supersaturated calcium phosphate rinse solution (Calphorinz solution) with standard chlorhexidine mouth wash for the prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009007
Enrollment
200
Registered
2017-07-10
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: null- Preventing mucositis in Patients undergoing stem cell transplantation

Interventions

Intervention1: Calphorinz solution: Calphorinz solution will be used by patients 4 times a day after mixture of calcium and phosphorus rinse solution (15 ml each in sachet). Control Intervention1: Hex

Sponsors

Institutional fundingChristian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing allogenic or autologous stem cell transplantation using the following conditioning regimens â?? For Allogeneic - [Cyclophosphamide and TBI, Busulfan based, Treosulfan based, Melphalan 140 mg/m2]; For autologous â?? [Melphalan 140 -200 mg/m2, BEAM conditioning]

Exclusion criteria

Exclusion criteria: Patients undergoing reduced intensity conditioning Patients unwilling to sign consent Children < 5 years of age

Design outcomes

Primary

MeasureTime frame
To study if the use of Calphorinz suspension will reduce the incidence of severe mucositis [Grade III & IV ]from 70% to 40% in patients undergoing allogeneic or autologous stem cell transplantation.Timepoint: Till Day 21—

Secondary

MeasureTime frame
To study if the use of Calphorinz suspension will reduce the incidence of severe mucositis [Grade III & IV ]from 70% to 40% in patients undergoing allogeneic or autologous stem cell transplantation.Timepoint: Till Day 14—

Countries

India

Contacts

Public ContactDr Biju George

Christian Medical College, Vellore

biju@cmcvellore.ac.in04162282352

Outcome results

None listed

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