| CTRI Number |
CTRI/2026/01/102290 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical evaluation of sarveshwara loha along with lifestyle modification in fatty liver [MASLD - Metabolic dysfunction associated steatotic liver disease] |
|
Scientific Title of Study
|
Evaluation of composite management of MASLD( METABOLIC [DYSFUNCTION] ASSOCIATED STEATOTIC LIVER DISEASE) with Sarveshwara loha and lifestyle modifications- A randomized placebo controlled clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh D Pandi K |
| Designation |
Phd Scholar |
| Affiliation |
Parul institute of Ayurveda |
| Address |
Department of Kayachikitsa, Parul institute of Ayurveda, Parul university, P O- Limbda,TAL: waghodia, Dist: Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9449078548 |
| Fax |
|
| Email |
dr.pandi71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vaishali Deshpande |
| Designation |
Professor and Phd guide |
| Affiliation |
Parul Institute of Ayurveda Parul University |
| Address |
Department of Kayachikitsa, Parul institute of Ayurveda, Parul university, P O- Limbda,TAL: waghodia, Dist: Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
Dr.vaishalid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRajesh D Pandi K |
| Designation |
Phd scholar |
| Affiliation |
Parul Institute of Ayurveda Parul University |
| Address |
Department of Kayachikitsa, Parul institute of Ayurveda, Parul university, P O- Limbda,TAL: waghodia, Dist: Vadodara
Padmamba Multispeciality hospital Main road Madanthyar post Pin code-574224 Belthangady Tq Dakshina kannada district Karnataka state
Vadodara
GUJARAT
391760
India |
| Phone |
9449078548 |
| Fax |
|
| Email |
dr.pandi71@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dean faculty of Ayurved parul university |
| Address |
P O Limbda Tal waghodia vadodara Gujarath |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh D Pandi K |
Alvas ayurveda medical college Hospital |
Room no 6 Kayachikitsa Opd,1st floor, 13, National highway Puttigepadavu, Moodabidri- 574227
Dakshina Kannada
KARNATAKA |
9449078548
dr.pandi71@gmail.com |
| Dr Rajesh D Pandi K |
Khemdas Hospital |
OPD NO 8,ground floor, Parul university Ishvarpura, AP Limda
Vadodara
GUJARAT |
9449078548
dr.pandi71@gmail.com |
| Dr Rajesh D Pandi K |
Padmamba Multispeciality Hospital |
Main Road Madanthyar- 574224
Dakshina Kannada
KARNATAKA |
9449078548
dr.pandi71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (IEC), parul institute of ayurved, Parul university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E713||Disorders of fatty-acid metabolism. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: -madhu with sheeta jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarveshwara loha , Reference: Bhishajya Rathnavali -41/140-146,, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: -madhu with sheetal jala), Additional Information: The formulation is in the form of fine powder which is filled into the capsules in 500mg strength |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 parameters |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
4months |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It has been known for many years that being overweight or obese is associated with hepatic steatosis, hepatocyte injury, liver inflammation, and fibrosis. This was formally recognised by the term "nonalcoholic fatty liver disease which was recently changed to MASLD. This randomized placebo controlled clinical study to evaluate the clinical efficacy of sarveshwara loha mentioned in a classical ayurveda formullary named bhishajya rathnavali compiled in the 18th century in the context of yakrithpleeha rogadhikara. MASLD as a disease entity closely resembles yakrityddalyudara in its 1st phase. Sarveshwara loha at present is not manufactured in india. So, an attempt is made to manufacture the present formulation and to study its clinical efficacy in the treatment of MASLD along with any ADR |