Clinical evaluation of sarveshwara loha along with lifestyle modification in fatty liver [MASLD - Metabolic dysfunction associated steatotic liver disease]

Evaluation of composite management of MASLD( METABOLIC [DYSFUNCTION] ASSOCIATED STEATOTIC LIVER DISEASE) with Sarveshwara loha and lifestyle modifications- A randomized placebo controlled clinical study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102290

Enrollment

144

Registered

2026-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: E713- Disorders of fatty-acid metabolism

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA Patients of either gender, irrespective of caste, religion, economic status. Patients between the age group of 35yrs & 65 Yrs Patients meeting any one of the following cardiometabolic criteria 1) BMI more than or is equal to 25 kg by meter square [23 Asia] OR WC more than or is equal to 94 cm (M) 80 cm (F) OR ethnicity adjusted 2) Fasting serum glucose more than or equal to 5.6 mmol per L [100 mg per dL] OR 2-hour post-load glucose levels greater or equal to 7.8 mmol per dl [mg per dL] OR HbA1c greater or equal to 5.7 percentage [39 mmol per L] OR type 2 diabetes OR treatment for type 2 diabetes 3) Blood pressure greater or equal to 130 by 85 mmHg OR specific antihypertensive drug treatment 4) Plasma triglycerides greater or equal 1.70 mmol per L [150 mg per dL] OR lipid lowering treatment 5) Plasma HDL-cholesterol greater or equal to 1.0 mmol per L [40 mg per dL] (M) and s 1.3 mmol per L [50 mg per dL] (F) OR lipid Iowering treatment FIB 4 Index score between FO - F2 NAFLD Fibrosis score between FO-F2

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA Patients associated with major organic and infective pathologies. Pregnancy and Lactating mother. Patient below the age of 35 yrs. and above the age of 65 yrs. Immuno compromised patients - HIV, AIDS Patients with already-decompensated liver disease by clinical or imaging evidence will be excluded. FIB 4 Index score between F3 - F4 NAFLD Fibrosis score between F3-F4

Design outcomes

Primary

Measure	Time frame
Primary Objectives - A. To evaluate the effect of composite management of MASLD with Sarveshwara loha and lifestyle modifications on the basis of clinical parameters B. To evaluate the effect of composite management of MASLD with Placebo and lifestyle modifications on the basis of clinical parameters . To compare the effect of composite management of MASLD between 2 treatment arms Sarveshwara loha and Placebo along with lifestyle modifications on the basis of clinical parametersTimepoint: 4 months	—

Measure

Time frame

Primary Objectives - A. To evaluate the effect of composite management of MASLD with Sarveshwara loha and lifestyle modifications on the basis of clinical parameters B. To evaluate the effect of composite management of MASLD with Placebo and lifestyle modifications on the basis of clinical parameters . To compare the effect of composite management of MASLD between 2 treatment arms Sarveshwara loha and Placebo along with lifestyle modifications on the basis of clinical parametersTimepoint: 4 months

—

Secondary

Measure	Time frame
Secondary Objectives - A. To evaluate the effect of composite management of MASLD with Sarveshwara loha and lifestyle modifications on the basis of Fib 4 Index, NAFLD Fibrosis Score, LFT, CBC, Lipid Profile And Fibroscan B. To evaluate the effect of composite management of MASLD with Placebo and lifestyle modifications on the basis of Fib 4 Index, NAFLD Fibrosis Score, LFT, CBC,Lipid Profile And Fibroscan C. To compare the effect of composite management of MASLD between 2 treatment arms Sarveshwara loha and Placebo along with lifestyle modifications on the basis of Fib 4 Index, MASLD Fibrosis Score, LFT, CBC,Lipid Profile And Fibroscan Timepoint: 4months	—

Measure

Time frame

Secondary Objectives - A. To evaluate the effect of composite management of MASLD with Sarveshwara loha and lifestyle modifications on the basis of Fib 4 Index, NAFLD Fibrosis Score, LFT, CBC, Lipid Profile And Fibroscan B. To evaluate the effect of composite management of MASLD with Placebo and lifestyle modifications on the basis of Fib 4 Index, NAFLD Fibrosis Score, LFT, CBC,Lipid Profile And Fibroscan C. To compare the effect of composite management of MASLD between 2 treatment arms Sarveshwara loha and Placebo along with lifestyle modifications on the basis of Fib 4 Index, MASLD Fibrosis Score, LFT, CBC,Lipid Profile And Fibroscan Timepoint: 4months

—

Countries

India

Contacts

Public ContactDrRajesh D Pandi K

Parul Institute of Ayurveda Parul University

Dr.vaishalid@gmail.com9096082950

Outcome results