| CTRI Number |
CTRI/2026/02/104434 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Shivagutika Herbal Treatment on Liver Health in Patients with Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
An Open-Label Randomized Controlled Clinical Study to Evaluate the Effect of Shivagutika Rasayana versus Sharapunkadi Churna in the Management of Non-Alcoholic Fatty Liver Disease w.s.r. to Kaphaja Yakritodara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreyashri N Suvarna |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady Udupi
SDM College of Ayurveda Hospital and Research Centre, Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9036441400 |
| Fax |
|
| Email |
shreyashravan91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreyashri N Suvarna |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady Udupi
SDM College of Ayurveda Hospital and Research Centre, Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9036441400 |
| Fax |
|
| Email |
shreyashravan91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreyashri N Suvarna |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady Udupi
SDM College of Ayurveda Hospital and Research Centre, Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9036441400 |
| Fax |
|
| Email |
shreyashravan91@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda Hospital and Reseach Centre Udupi
574118 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda Hospital and Reseach Centre Udupi |
| Address |
SDM College of Ayurveda Hospital and Reseach Centre Udupi
574118 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHREYASHRI N SUVARNA |
SRI DHARMASTHALA MANJUNATHESHWARA AYURVEDA HOSPITAL UDUPI |
Department of Kayachikitsa, OPD No. 7, SDM COLLEGE OF AYURVEDA
HOSPITAL AND RESEARCH CENTRE, LAXMINARAYANA NAGARA, KUTHPADY
UDUPI- 574118
Udupi
KARNATAKA |
9036441400
shreyashravan91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Human Ethical Committee SDMCAH&RU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHIVAGUTIKA, Reference: ASTANGA SANGRAHA, UTTHARASTHANA, ADHYAYA 49:169, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: USHNAJALA), Additional Information: Haritaki Churna 3-5gms will be administered for Koshtashodhana. | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: SHARAPUNKADI CHURNA, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Ushnajala), Additional Information: aritaki Churna 3-5gms will be administered for Koshtashodhana. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient fitting into the diagnostic criteria.
Subjects fit to undergo treatment protocol as per the study protocol and voluntarily
give written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with history of alcohol intake.
Patients with recent positive history of other liver diseases such as viral hepatitis, autoimmune hepatitis, Wilsons disease, alpha 1 antitrypsin deficiency,
hemochromatosis.
Patients having fasting blood sugar (FBS) more than 200 mgdl and postprandial blood sugar
(PPBS) more than 250 mgdl, despite taking oral hypoglycemic agents, Stage II hypertension,
i.e., systolic blood pressure more than 160 mmHg and diastolic blood pressure more than 100 mmHg,
despite taking antihypertensive drugs
Any other conditions, which in the opinion of the investigator/s, makes the patient
unsuitable for enrollment or could interfere with his/her participation and completion
of the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of changes in USG Abdomen for Liver
• Assessment of changes in the Biochemical analysis.
• Liver Function Test
• Lipid profile |
at Baseline, 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective Parameters
• Body Mass Index (BMI)
• Blood Pressure
• Waist Circumference
• BRAD Score
• Fib-4 Score
• Quality of life scale (WHO-QOL-BREF)
Subjective parameters
Symptoms of Kaphaja yakritodara & other metabolic symptoms
• Gauravata (Heaviness of the body)
• Aruchi(Loss of taste)
• Katinyata (Hardness of Abdomen)
• Avipaka(Indigestion)
• Dourbalya(Debility)
• Belching
• Vomiting
• Itching
• Abdominal heaviness
• Abdominal distension
• Flatulence
• Constipation
• Diarrhoea |
at Baseline, 8th week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is the Randomized, Open Label, Parallel Group single centred trial comparing the efficacy of Shivagutika rasayana and Sharapunkadi Churna in 100 subjects with Non-Alcoholic Fatty Liver Disease in India. The study includes 63-65 days of intervention (mrudu virechana+medication) and 30 days of follow up period. Total duration of study: 93-95 days. The primary outcome measures will be changes in USG Abdomen for Liver, Biochemical analysis including Liver Function Test and Lipid profile. Secondary outcome measures includes Body Mass Index (BMI), Blood Pressure, Waist Circumference, BRAD Score, Quality of life scale (HRQoL).
|