| CTRI Number |
CTRI/2025/02/081237 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Daily Purgation with Narayana Churna in Managing Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
Effect of Nitya Virechana with Narayana Churna in the Management of 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 |
DrSheejaS |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurveda College Hospital,Tripunithura |
| Address |
Department of Panchakarma,
Government Ayurveda College Hospital,Tripunithura,Ernakulam
Govt Ayurveda College Hospital Tripunithura Ernakulam Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9061774477 |
| Fax |
|
| Email |
doctorsheeja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSeenaS |
| Designation |
Professor and HOD, Department of Panchakarma , Government Ayurveda College Hospital,Tripunithura |
| Affiliation |
Govt Ayurveda College Hospital,Tripunithura |
| Address |
Department of Panchakarma, Government Ayurveda College Hospital, Tripunithura
Govt Ayurveda College Hospital Tripunithura Ernakulam Kerala
Ernakulam
KERALA
682301
India |
| Phone |
09447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSeenaS |
| Designation |
Professor and HOD, Department of Panchakarma , Government Ayurveda College Hospital,Tripunithura |
| Affiliation |
Govt Ayurveda College Hospital,Tripunithura |
| Address |
Department of Panchakarma ,Government Ayurveda College Hospital, Tripunithura
Govt Ayurveda College Hospital Tripunithura, Ernakulam ,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
09447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Hospital,Tripunithura, Puthiyakavu, Ernakulam,Kerala, India.Pin-682301 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Tripunithura, Ernakulam |
| Address |
Government Ayurveda College Tripunithura,Puthiyakavu, Ernakulam, Kerala, India.Pin-682301 |
| Type of Sponsor |
Government 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 |
| DrSheejaS |
Government Ayurveda College Hospital |
Department of Panchakarma,
Govt Ayurveda College Hospital,Puthiyakavu, Tripunithura , Pin-682301 ,Ernakulam ,Kerala,India
Ernakulam
KERALA |
9061774477
doctorsheeja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research, Government Ayurveda College,Tripunithura, Kochi, ,Kerala, India, Pin-682301 |
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: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Ashtanga Hridaya, Procedure details: The patient will be administered 12 g Narayana churna at bed time with hot water.)
(1) Medicine Name: Narayana churna, Reference: Ashtanga hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: hs, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subject among age group 30-55 who are diagnosed as fatty liver Grade 1and 2, diagnosed by USG and Fibroscan in a sub group at the OPD and IPD of Govt. Ayurveda College Hospital ,Tripunithura. |
|
| ExclusionCriteria |
| Details |
1.Known cases of Major Systemic illness
2.Known cases of Malignancy
3.Known cases of Portal hypertension
4.Known cases of Splenomegaly
5.Pregnant and lactating women
6.Subjects having Mridu koshta
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the grade
of fatty liver as observed through USG Abdomen |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in the score
of NAFLD fibrosis score
2. Change in the Liver function test
(LFT).
3.Change in the Lipid profile
4.Assessing Samyak virechana lakshana
5. Change in the stiffness of liver as observed through Elastography of liver in a sub group |
30 days |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
08/03/2025 |
| 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 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 trial is conducted to assess the Effect of Nitya Virechana with Narayana Churna in the Management of Non alcoholic Fatty Liver Disease. During the intervention the participants will be given 12 g Narayana Churna with hot water at bed time for a period of 30 days as Nitya Virechana.The study will be conducted in Government Ayurveda College Hospital, Tripunithura having laboratory and USG facility which makes the study more feasible .The study design is pre and post- study .A sample of 28 will be selected based on inclusion and exclusion criteria.The subjects will be administered Narayana churna for the first 10 days on IP basis and the remaining duration on OP basis. The assessment of Virechana will be done daily basis.They will be subjected to detailed clinical evaluation and investigation including USG Abdomen, LFT, Lipid profile ,Platelet, Electrolyte, RFT and FBS. Fibrosis score will also be calculated .Elastography will be done for a sub group. USG and Elastography will be done before and after the treatment. All the above blood tests will be checked on 10 th, 20 th ,30 th and 60 th day. Data collection will be done through case proforma,USG abdomen , blood tests and elastography in a sub group.Data collected will be statically analysed through appropriate tests and conclusion will be drawn. |