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Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01392131
First received: July 7, 2011
Last updated: December 11, 2012
Last verified: December 2012
History of Changes

July 7, 2011
December 11, 2012
July 2011
December 2012   (final data collection date for primary outcome measure)
Number of patients who have prolonged survival after receiving Oncoxin [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
To study the number of participants who have prolonged survival after receiving Oncoxin for 24 weeks.
Same as current
Complete list of historical versions of study NCT01392131 on ClinicalTrials.gov Archive Site
Reduction in serum alpha-fetoprotein level and decrease in tumor size [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
To see whether Oncoxin results in reduction in serum alpha-fetoprotein level and decrease in tumor size in hepatocellular carcinoma patients off treatment for 24 weeks, after receiving Oncoxin for 24 weeks.
Same as current
Not Provided
Not Provided
 
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

Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma

To assess therapeutic efficacy and safety of Oncoxin in hepatocellular carcinoma

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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Dietary Supplement: Oncoxin
    20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
    Other Name: Viusid
  • Other: Supportive treatment
    patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed
  • Active Comparator: Oncoxin will be administered orally
    20 patients will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
    Intervention: Dietary Supplement: Oncoxin
  • Active Comparator: Supportive treatment
    20 patients with hepatocellular carcinoma will receive supportive treatment only
    Intervention: Other: Supportive treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT01392131
OP1
Yes
Clinical Research Organization, Dhaka, Bangladesh
Clinical Research Organization, Dhaka, Bangladesh
Not Provided
Principal Investigator: Mamun A Mahtab, MSc MD FACG Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Clinical Research Organization, Dhaka, Bangladesh
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP