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To Study the Efficacy and Safety of Renessans in Chronic HCV Patients

NCT01463592 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-11-22

No results posted yet for this study

Summary

Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately 6-10% of the general public is expected to be suffering from this infection. In case that these patients are not treated at an appropriate time, these patients develop the sequelae of the chronic liver disease e.g. cirrhosis of liver, Ascites, and Hepatocellular carinoma. Interferon alpha 2 a or alpha 2b injections and Ribavirin combination is the treatment of choice for people suffering from Chronic HCV infection and this combination need to be administered for 6-12 months. Interferons are biological agents and are to be administered parenterally. Interferons are expensive and are associated with number of minor and major adverse effects. Ribavirin is also associated with significant adverse effects. These compounds cannot be considered as one of the ideal forms of the treatment.

In the past, quite a few natural products have been tested to assess their hepatoprotective activity and possibly anti viral activity as well. These include Vitamin C (Ascorbic acid), Vitamin E, Zinc, Silymarin, Red beet roots, crushed licorice and etc. etc.

Rationale Iodine , Potassium iodide and Ascorbic acid are natural products used in the management of Thyroiditis and chronic cutaneous fungal infections. This combination of iodine compounds along with ascorbic acid is being used for the management of chronic hepatitis B \& C in the central Asian states e.g. Kazakhstan etc.

The investigators have conducted a feasibility study in which oral Iodine Compound {RENESSANS} was given to patients suffering HCV related Chronic Active Hepatitis and anti-viral activity and safety has been analyzed. In this study, RENESSANS containing regimen has been well tolerated by all the patients and has shown some antiviral activity.

In this study the investigators will assess whether the administration of RENESSANS {oral } improves the antiviral activity in patients receiving standard interferon therapy.

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

RENESSANS , INTERFERON ALPHA 2b, Ribavirin

ORAL RENESSANS 5gm. Twice Daily +INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg

DRUG

Interferon Alfa-2b AND RIBAVIRIN

INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg

BIOLOGICAL

RENESSANS

ORAL RENESSANS 5gm. Thrice Daily{active iodine 300mg} for 6months

Sponsors & Collaborators

  • MTI Medical Private Limited, Pakistan

    lead OTHER

Principal Investigators

  • GHIAS UN NABI, FCPS,MRCP · PROFESSOR OF MEDICINE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463592 on ClinicalTrials.gov