Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Homoeopathic Treatment: Homoeopathic dilutions selected on the basis of the individualizing symptoms of the participant shall be administered in oral form. The dilutions shall be dispen
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients visiting the OPD of study centers with ultrasonography evidence of fatty changes in the liver on incidental discovery. 2. Fatty liver changes demonstrated by ultrasonography in patients with incidental increase in liver transaminases (ALT and AST) 3. Fatty liver changes demonstrated by ultrasonography in persons screened with either of increased waist circumference (more than 90cm in males and more than 80cm in females), impaired fasting glucose (Fasting glucose more than equal to 110 mg/dl or on pharmacological treatment for impaired glucose), increased blood pressure (more than equal to 130/85 mm of Hg or on antihypertensives), hypertriglyceridemia (Serum triglycerides more than equal to 150mg/dl or on triglyceride or lipid lowering drugs), decreased HDL levels (less than 40 mg/dl in males and less than 50 mg/dl in females). 4. Patients presenting with Grade 1 (mild) or Grade 2 (Moderate) fatty liver on ultrasound examination 5. Patients with transient elastography (FibroScan) Liver Stiffness Measurement scores of less than 9.3kPa (by M probe) and less than 9.6kPa (by XL probe) 6. Patients with FIB 4 score less than equal to 1.45 7. Age 18 to 75 years of age 8. All sexes 9. Patients on oral hypoglycemic drugs, antihypertensives, lipid lowering drugs, and LT4 drugs with controlled disease conditions for which such drugs are administered. 10. Patients with ability to perform and comply to exercise and lifestyle modifications 11. Willing to give consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from self-reported cases of liver cirrhosis, hepatocellular carcinoma, hereditary hemochromatosis, Wilson s disease, alpha 1 antitrypsin deficiency or any other malignancy or any end-stage disease. 2. Patient with positive HbsAg and/or anti HCV antibody. 3. Patients with associated acute or chronic cholecystitis (calculous or acalculous). Patients with such conditions may be included after 6 months of cholecystectomy 4. Drug-induced liver disease 5. Patient with a history of regular alcohol intake demonstrated by CAGE scores of more than equal to 3 6. Patients who are immune-compromised or have steroid medication. 7. Pregnant and lactating mothers 8. Persons with severe Musculoskeletal disorders and unable to perform the prescribed physical activities and exercise. 9. Persons with severe mental illness like mania, insanity. 10. Persons not willing to provide consent for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Qualitative assessment of the liver by ultrasonography: Timepoint: The scoring shall be done at baseline, 6 months and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative assay of serum triglyceride and high-density lipoprotein cholesterol level Timepoint: At baseline and at the end of study at 12 months;Assessment of causality of adverse events using Naranjo ADR probability scale Timepoint: At any period during the study whenever any adverse reaction is noted;CAP score by fibroscanTimepoint: The assessment shall be performed at baseline, 6 months and 12 months;Quantitative assay of Alanine Aminotransferase (ALT) Timepoint: The assay shall be performed at baseline, 6 months and 12 months;Liver Stiffness measure score using transient elastography (Fibroscan) Timepoint: The scoring shall be done at baseline, and end of 12 months follow-up;Liver fibrosis by Fib 4 scores Timepoint: The assessment shall be performed at baseline, 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDr Varanasi Roja
Regional Research Institute for Homoeopathy, Siliguri
Outcome results
None listed