Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)
Study to Evaluate Safety and Therapeutic Efficacy of a Nutritional Supplement 'Oncoxin' in Patients With Hepatocellular Carcinoma
1 other identifier
interventional
40
1 country
1
Brief Summary
Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hepatocellular-carcinoma
Started Jul 2011
Shorter than P25 for phase_1 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 7, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 12, 2012
December 1, 2012
1.4 years
July 7, 2011
December 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who have prolonged survival after receiving Oncoxin
To study the number of participants who have prolonged survival after receiving Oncoxin for 24 weeks.
48 weeks
Secondary Outcomes (1)
Reduction in serum alpha-fetoprotein level and decrease in tumor size
48 weeks
Study Arms (2)
Oncoxin will be administered orally
ACTIVE COMPARATOR20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
Supportive treatment
ACTIVE COMPARATOR20 patients with hepatocellular carcinoma will receive supportive treatment only
Interventions
20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed
Eligibility Criteria
You may qualify if:
- Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
- Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who have evidence of tumor metastasis
- Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC in whom all possible treatment options have been exhausted.
You may not qualify if:
- Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who have no evidence of tumor metastasis
- Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who are voluntarily unwilling to be included in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Farabi General Hospital
Dhaka, 1205, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mamun A Mahtab, MSc MD FACG
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2011
First Posted
July 12, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
December 12, 2012
Record last verified: 2012-12