Health Condition 1: K739- Chronic hepatitis, unspecified Health Condition 2: null- HCV positive patients will be enrolled in study. HCV positive patient who are also positive for the HIV and/or HbSAg will not be included in the study.
Conditions
Interventions
Intervention1: ImHelp 30C and 50C potency: 30c for 3 months and 50c for next 3 months.: ImHelp Dose: 6 pills 3 times in a day sublungually- oral administration. Study is duration 6 months.
Interventio
Sponsors
Homeopathy India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: HCV Viral load levels: > 5,00,000 IU/mL, Patients must not have received any experimental HCV vaccines. Be free from any acute infection or serious medical illness within 14 days prior to study entry. Ambulatory status, and ability and willingness to give informed consent. Patients without actual or suspected allergies to any component of Investigational product.
Exclusion criteria
Exclusion criteria: Leukocytes 1.5 mg/mL, Any other chronic infection (hepatitis B co-infection, HIV co-infection) Patients treated with conventional anti-Hep C (interferon) treatment during last one year, Cancer of liver (detected in USG) or any form of malignancy, Having shown symptoms of Esophageal varices, Renal failure ,Co-existent serious cardiac and respiratory diseases, Neuropsychiatric disorders, Lactating mothers, Alcohol abuse, Insulin resistant diabetics. Patients with chronic hepatitis C are at risk of developing type 2 diabetes mellitus (DM) and impaired fasting glucose (IFG), and this risk may increase among hepatitis C virus (HCV) patients not responding to an antiviral therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardization of the new homoeopathy medicine ImHelp (IP), To evaluate the safety of the IP during the course of the treatment, Efficacy evaluation of HCV nosode (IP), Recording of new symptoms and adverse effects, if any. Timepoint: Standardization of the new homoeopathy medicine (It is a procedure, baseline and 6 months) 2. Safety evaluation( 6 months). 3. Efficacy evaluation(3 and 6 months). 4. Recording of new symptoms and adverse effects, if any(3 and 6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in HCV viral load from baseline To evaluate the % of patients for sustained reduction in viral load after 12 and 24 weeks of treatment. Timepoint: Clinical-Every 6weeks. Lab. parameters- every three months. (viral Load) | — |
Countries
India
Contacts
Public ContactDr Rajesh Shah
Life Force Center
Outcome results
None listed