Efficacy Of Individualized Homoeopathic Medicines In The Management Of Non Alcoholic Fatty Liver Disease: A Prospective Randomized Single Blind Placebo Controlled Trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 354
- Locations
- 1
- Primary Endpoint
- Significant changes in the scores of Chronic Liver Disease Questionnaire for NAFLD/NASH(CLDQ NAFLD/NASH )
Study Overview
Brief Summary
Non Alcoholic Fatty Liver Disease (NAFLD) is characterized by the presence of macro-vesicular steatosis in at least 5% of hepatocytes, without any secondary causes like alcohol or drug use. This condition includes a range of disease states, starting from non-alcoholic fatty liver (NAFL) and progressing through non-alcoholic steato-hepatitis (NASH), fibrosis, and ultimately cirrhosis.NAFLD stands out as a prominent liver disease globally, with an estimated global incidence of 47 cases per 1,000 population. This incidence is higher among males than females. The prevalence of NAFLD in India accounts for about 9-32% of general population.. Homoeopathic medicines improves the overall biological processes and reinstates the homoeostasis needed for the efficient functioning of the organ.
NAFLD being a life style disorder is becoming prevalent and managing NAFLD involves making sustainable lifestyle changes that promote a healthy weight, balanced nutrition, and overall well-being. A holistic approach encompassing dietary modifications, physical activity, and stress management along with homoeopathic treatment is critical to reducing the risk of NAFLD and its associated complications. Previous studies conducted on managing NAFLD with homoeopathy are few in number and mostly based on specific medicines with organ affinities. This study is an attempt to prove to be a landmark in assessing the role of Individualized homoeopathic medicine in the management of NAFLD along with Lifestyle modification . A single blind randomized placebo controlled (1:1) trial will be conducted on 354 adults who are suffering from NAFLD at OPD of Pt. JLN Homoeopathic Medical College and Hospital . Primary outcome assessment will be done by evaluating the significant difference in CLDQ -NAFLD/NASH questionnaire after 12 months. Secondary Outcome assessment will be done by evaluating Serum ALT levels and Changes in BARD score after 12 months of Baseline Intervention . Group differences will be analyzed statistically . Result will be published in peer reviewed scientific journal .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Individuals with Grade I to III NAFLD established by Ultrasonography and or ALT enzymes level more than 30 IU per mL in males and more than 19 IU per mL in females Clinically diagnosed cases of Fatty Liver Patients willing to give consent either.
Exclusion Criteria
- •Pregnant females and lactating mothers will be excluded Individuals not providing written informed consent for the study Patient with existing from liver diseases like Alcoholic Fatty Liver Grade IV Non Alcoholic fatty Liver disease viral hepatitis Autoimmune liver diseases hepatocellular carcinoma Patient with Uncontrolled Diabetes Uncontrolled Hypertension renal or cardiac disease stroke or any other serious systemic illness Patient on any other medication Patient with medical emergencies.
Outcomes
Primary Outcomes
Significant changes in the scores of Chronic Liver Disease Questionnaire for NAFLD/NASH(CLDQ NAFLD/NASH )
Time Frame: At Baseline 4th month 8th month 12th month
Secondary Outcomes
- Serum ALT level(At Baseline 4th month 8th month 12th month)
- Significant changes in BARD Score(At Baseline 4th month 8th month 12th month)
Investigators
DrRajesh Kumar Verma
Pt JLN State Homoeopathic Medical College and Hospital