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Evaluation of Siravedha (Bloodletting Therapy) along with Lifestyle Modification in the Treatment of Fatty Liver Disease (MASLD)

Efficacy of Siravedha along with Life Style Modification in the Management of Yakriddaalyudara (MASLD)-An Open Labelled Randomize Controlled Clinical Trial - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112082
Enrollment
38
Registered
2026-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K768- Other specified diseases of liver

Interventions

None listed

Sponsors

Institute of Teaching and Research in Ayurveda, Jamnagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex of age group, 20 years to 60 years Both newly detected and previously diagnosed cases of Metabolic Dysfunction Associated Steatotic Liver Disease USG findings suggestive of fatty liver grade I & II Patients of Yakriddaalyudara (Metabolic Dysfunction-Associated Steatotic Liver Disease) with controlled blood pressure (100 to 140 mm of HG systolic and 80 to 90 mm of hg diastolic pressure) & Diabetic Mellitus (RBS 90 to 140 mg/dl)

Exclusion criteria

Exclusion criteria: Patient aged below 20 years and above 60 years pregnant women Patients with uncontrolled Diabetes or Hypertension Patients with complications of Metabolic syndrome like Cerebrovascular accident (CVA) Myocardial Infarction (MI) chronic kidney disease (CKD) Patients suffering from GB stone or obstructive jaundice Patients consuming Hepatotoxic medicines Alcohol or other Narcotic substances Patients suffering from Cirrhosis Ascites variceal hemorrhage Coagulopathy Hepato Renal Syndrome Patients having history of Viral hepatitis (HBsAg HCV) Autoimmune liver diseases (Primary biliary cirrhosis primary sclerosing cholangitis autoimmune hepatitis) Metabolic disorders (Wilsons disease haemochromatosis) congenital blood diseases (sickle cell disease thalassemia G6PD deficiency anemia etc) Patients suffering from HIV TB other infectious diseases Malignancies major psychiatric problems or any other serious illnesses Hb less then 10 gm %

Design outcomes

Primary

MeasureTime frame
Symptomatic relief Pain intensity will be assessed using a 0 10 Visual Analogue (VA) Scale, where 0 indicates no pain and 10 indicates unimaginable and unspeakable pain. Intermediate scores represent increasing severity of pain, ranging from very light, barely noticeable pain (score 1), mild discomforting pain (score 2), noticeable pain adapted to by the patient (score 3), strong distressing pain (score 4), strong deep piercing pain affecting normal lifestyle (score 5), very strong pain interfering with work and daily activities (score 6), very strong deep piercing pain (score 7), very strong pain associated with severe personality changes when prolonged (score 8), and pain severe enough for the patient to demand analgesics or surgery regardless of risks (score 9).Timepoint: 1 MONTH

Secondary

MeasureTime frame
Changes in laboratory parameters & USG findings The clinical symptoms associated with fatty liver disease will be assessed using a symptom-based scoring system. The symptoms evaluated will include dyspepsia, nausea, malaise, fatigue, feeling of fullness in the abdomen, generalized weakness, & upper abdominal pain/discomfort. Each symptom will be scored as 0 when absent & 1 when present. The total symptom score will be calculated by summing the scores of all symptoms, with higher scores indicating greater symptom burden. Assessment will be carried out before & after treatment.Timepoint: 60 days

Countries

India

Contacts

Public ContactDr Y R MEGHANI

nstitute of Teaching and Research in Ayurveda (ITRA) Jamnagar

yogs4yogs@gmail.com9924982435

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026