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Homeopathic treatment of fatty liver

Phase 2
Conditions
Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Registration Number
CTRI/2024/03/064635
Lead Sponsor
D.N. De Homoeopathic Medical College and Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Individuals with Grade I and Grade II Fatty liver established by Ultrasonography and ALT enzyme levels greater than upper limit of normal. (upper limit of normal ALT is considered to be more than 30 IU/mL in males and more than 19 IU/mL in females ).

2.Age 18 to 65 years.

3.Participants of either sex or transgender.

4.Participants having prior experience or knowledge of the treatment; example - primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet

Exclusion Criteria

1.Not providing with written informed consent of voluntary participation.

2.Regular or excessive use of alcohol, tobacco, substance abuse and any other addiction.

3.Individuals with NAFLD Fibrosis Score more than 0.675.

4.History of Viral hepatitis B or C, autoimmune hepatitis.

5.Cholestatic and metabolic liver diseases, hemochromatosis and liver transplants.

6.Combined with uncontrolled diabetes (participants under modern medications having poor glycemic control denoted by HbA1c more than 6.5%), uncontrolled hypertension (SBP more than 140 and DBP more than 90 mm of Hg with modern medications), renal or cardiac disease, stroke or any other severe systemic diseases affecting quality of life.

7.Person under corticosteroid therapy.

8.Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill, mentally incompetent people.

9.Pregnant and puerperal women and lactating mother.

10.Self-reported immune-compromised state.

11.Already undergoing homoeopathic treatment within last 3 months for any other disease.

12.Simultaneous participation in any other trials.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serum ALT levelTimepoint: At baseline and after 3 months
Secondary Outcome Measures
NameTimeMethod
Blood lipid profile (Triglycerides, Total cholesterol, Very-Low-Density Lipoprotein cholesterol, High-density Lipoprotein cholesterol, Low-Density Lipoprotein cholesterol)Timepoint: At baseline and after 3 months;Chronic liver disease questionnaire (CLDQ)Timepoint: Baseline, every month, up to 3 months;Liver function test (Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, Total Protein, Albumin, Globulin, AST, ALP).Timepoint: At baseline and after 3 months;Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)Timepoint: Baseline, every month, up to 3 months
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