| CTRI Number |
CTRI/2026/02/103084 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Ayurvedic Medicated Enema Therapy In Reducing Liver Fat With Early Stage Non Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
EFFECT OF SIDDHA VASTI IN THE MANAGEMENT OF GRADE 1 AND 2 NON - ALCOHOLIC FATTY LIVER DISEASE (NAFLD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muley Pratik Pradeep |
| Designation |
PG Scholar Department Of Panchakarma |
| Affiliation |
Government Ayurveda College And Hospital Tripunithura |
| Address |
OP Number 5, Department Of Panchakarma , Government Ayurveda College And Hospital Tripunithura , Puthiyakavu
Ernakulam
Kerala
Ernakulam
KERALA
682301
India |
| Phone |
8788543677 |
| Fax |
|
| Email |
pratikmuley99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seena S |
| Designation |
Professor And HOD Department Of Panchakarma |
| Affiliation |
Government Ayurveda College And Hospital Tripunithura |
| Address |
OP Number 5, Department Of Panchakarma , Government Ayurveda College And Hospital Tripunithura , Puthiyakavu
Ernakulam
Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seena S |
| Designation |
Professor And HOD Department Of Panchakarma |
| Affiliation |
Government Ayurveda College And Hospital Tripunithura |
| Address |
OP Number 5, Department Of Panchakarma , Government Ayurveda College And Hospital Tripunithura , Puthiyakavu
Ernakulam
Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College And Hospital Tripunithura Puthiyakavu Ernakulam Dist Pin 682301 |
|
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Primary Sponsor
|
| Name |
Government Ayurveda College Tripunithura |
| Address |
Government Ayurveda College And Hospital Tripunithura Puthiyakavu Ernakulam Kerala India Pin 682301 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seena S |
Government Ayurveda College Tripunithura Puthiyakavu Ernakulam |
OPD 5 And IPD Department Of Panchakarma Government Ayurveda College And Hospital Tripunithura Puthiyakavu Ernakulam KERALA
Ernakulam
KERALA |
9447190133
seenas279@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Government Ayurveda College, Tripunithura , Kochi , Kerala - 682301 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: MEDOROGAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | siddha-bastiH, सिद्ध-बस्तिः | (Procedure Reference: Susrutha Samhita, Chikitsa Sthana 38 th Chapter Niruhakrama Chikitsitham, Procedure details: Siddha Vasti is a type of Niruha Vasti described by Acharya Susrutha. It possesses Kapha-Medohara, Lekhana and Srotoshodhana properties. In the present study, Siddha Vasti is administered in Madhu-Tailika pattern.
Total Vasti Dravya Dose: 852 ml
Duration of administration: 7 consecutive days
Study population: Patients diagnosed with Grade 1 and Grade 2 Non-Alcoholic Fatty Liver Disease (NAFLD).
Age group: 25–55 years
1. Poorva Karma (Pre-procedure)
Deepana–Pachana is given for 3 days prior to Vasti.
Medicine used: Gandharvahasthadi Kashayam
Dose: 90 ml
Frequency: Twice daily
Time: One hour before food
On the day of Vasti:
Patient is advised light, easily digestible food. Local Abhyanga with Shatahwadi Anuvasana Tailam is done. Followed by local Ushma Sweda.
2. Preparation of Siddha Vasti Dravya
The Vasti medicine is prepared by triturating the drugs in the following classical order:
Saindhava (Rock salt) – 12 g
Makshika (Madhu / Honey) – 204 ml
Sneha (Shatahwadi Anuvasana Tailam) – 204 ml
Kalka (Pippali & Yashtimadhu) – 24 g
Kashaya (Yava, Kola, Kulatha) – 408 ml
The mixture is triturated until a homogeneous consistency is achieved. The prepared Vasti dravya is filtered, gently warmed to lukewarm temperature, and filled into the Vasti Putaka.
3. Pradhana Karma (Administration of Vasti)
Time of administration: Between 10:30 AM – 11:30 AM
Position: Left lateral position
Left leg extended
Right leg flexed
Procedure steps: Nozzle and gloved finger are lubricated with oil. Per rectal examination is done to rule out obstruction. Air is expelled from the Vasti Netra. Nozzle is introduced gently and parallel to the vertebral column. Medicine is administered slowly and steadily. Nozzle is removed carefully, leaving a small amount of medicine to prevent air entry.
After administration: Patient is advised to lie in supine position. Rest is advised until the urge for defecation occurs.
4. Paschat Karma (Post-procedure)
After proper evacuation of Vasti dravya and stool , Lukewarm water bath will be advised. To Patient, Cooked rice with Mudga Yusha will be given. Pathya-Apathya will be explained and strictly advised during treatment and follow-up.
5. Treatment and Follow-up Schedule
Total duration of Vasti: 7 days
Assessment days:
•Assessment of reduction in the grade of fatty liver using USG
First assessment - 0th day, Second assessment – 22nd day
•Assessment using the NAFLD Fibrosis score
First assessment - 0th day, Second assessment – 8th day, Third assessment – 22nd day
•Assessment using Lipid Profile
First assessment - 0th day, Second assessment – 8th day, Third assessment – 22nd day
•Assessment using LFT
First assessment - 0th day, Second assessment - 8th day, Third assessment – 22nd day
•Assessment of Vasti- Daily through Samyak lakshanas of niruha vasti.
)
(1) Medicine Name: Gandharvahasthadi Kashayam, Reference: Sahasrayogam , Kashayaprakarana , Verse 394, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 90(ml), Frequency: bd, Duration: 3 Days(2) Medicine Name: Saindhavam, Reference: Susrutha Samhita, Chikitsa Sthana 38 th Chapter Niruhakrama Chikitsitham , Route: Rectal, Dosage Form: Lavana, Dose: 12(g), Frequency: od, Duration: 7 Days(3) Medicine Name: Makshikam, Reference: Susrutha Samhita, Chikitsa Sthana 38 th Chapter Niruhakrama Chikitsitham, Route: Rectal, Dosage Form: Not Applicable, Dose: 204(ml), Frequency: od, Duration: 7 Days(4) Medicine Name: Shatahwadi Anuvasana Tailam , Reference: Kanjiv Lochan-Ashtanga Hridayam -In Kalpa sthanam -Chaukhambha Publications, Edition F, Route: Rectal, Dosage Form: Taila, Dose: 204(ml), Frequency: od, Duration: 7 Days(5) Medicine Name: Kalka (Pippali And Yashti), Reference: Susrutha Samhita, Chikitsa Sthana 38 th Chapter Niruhakrama Chikitsitham, Route: Rectal, Dosage Form: Kalka/ Paste, Dose: 24(g), Frequency: od, Duration: 7 Days(6) Medicine Name: Kashayam (Yava, Kola, Kulatha), Reference: Susrutha Samhita, Chikitsa Sthana 38 th Chapter Niruhakrama Chikitsitham, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 408(ml), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subject with NAFLD Grade 1 And 2
Subjects within the age group of 25 To 55 years
Subjects fit for Niruha Vasti
Subjects who will give written consent
|
|
| ExclusionCriteria |
| Details |
Participants with Major Systemic illness
Participants with Malignancy
Participants with Portal Hypertension
Participants with Splenomegaly
Pregnant and lactating women
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change In The Score Of NAFLD Fibrosis score |
Assessment will be on 0th day,8th day And 22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.USG Abdomen
2.Liver Function Test
3.Lipid Profile
4.Samyak Niruha Lakshana Assessment |
1.Assessment of reduction in the grade of fatty liver using USG :First assessment will be on 0th day And Second Assessment will be on 22nd day
2.Assessment using Liver Function Test: First assessment will be on 0th day, Second assessment will be on 8th day And Third assessment will be on 22nd day
3.Assessment using Lipid Profile :First assessment will be on 0th day, Second assessment will be on 8th day And Third assessment will be on 22nd day
4.Samyak Niruha Lakshana Assessment : Daily Through Samyak Lakshanas Of Niruha Vasti
|
|
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Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 4 |
|
Date of First Enrollment (India)
|
18/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Non-Alcoholic Fatty Liver Disease (NAFLD) is a prevalent lifestyle related hepatic disorder marked by abnormal accumulation of fat in the liver. If not addressed at an early stage, it may progress to advanced conditions such as fibrosis, cirrhosis, and hepatocellular carcinoma. At present, there is no established definitive pharmacological therapy for early stage NAFLD, Emphasizing the need to explore alternative treatment modalities. From an Ayurvedic perspective, NAFLD can be understood in relation to Santarpanajanya Vyadhi and Medoroga, Wherein deranged Agni along with vitiation of Kapha and Meda plays a central role in the disease pathogenesis. Siddha Vasti, as described in classical Ayurvedic literature, is known to possess Kapha Medohara, Lekhana, and Srotoshodhana properties, which may be beneficial in the management of NAFLD. This study is designed as a single arm, interventional pre and post test clinical trial involving 25 participants aged between 25 and 55 years, diagnosed with Grade 1 and Grade 2 NAFLD. Siddha Vasti will be administered for 7 consecutive days. Clinical and biochemical assessments will be carried out at baseline, on the 8th day, and on the 22nd day using the NAFLD fibrosis score, liver function tests, and lipid profile. While ultrasonography of abdomen will be carried out at baseline and on 22 nd day . Samyak Lakshanas of niruha vasti will be assessed daily. The primary objective of the study is to evaluate the effectiveness of Siddha Vasti in improving fibrosis scores and reducing the severity of NAFLD. The outcomes of this study may contribute to scientific evidence, supporting the role of Panchakarma therapy, particularly Siddha Vasti, in the management of early stage NAFLD. |