Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)
NCT ID: NCT01392131
Last Updated: 2012-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2011-07-31
2013-07-31
Brief Summary
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Detailed Description
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To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin
To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin
To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin
To see if there is improved survival in hepatocellular carcinoma patients after administration of oncoxin
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oncoxin will be administered orally
20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
Oncoxin
20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
Supportive treatment
20 patients with hepatocellular carcinoma will receive supportive treatment only
Supportive treatment
patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed
Interventions
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Oncoxin
20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
Supportive treatment
patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
ALL
No
Sponsors
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Clinical Research Organization, Dhaka, Bangladesh
OTHER
Responsible Party
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Principal Investigators
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Mamun A Mahtab, MSc MD FACG
Role: PRINCIPAL_INVESTIGATOR
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Locations
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Farabi General Hospital
Dhaka, , Bangladesh
Countries
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Other Identifiers
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OP1
Identifier Type: -
Identifier Source: org_study_id