| CTRI Number |
CTRI/2025/01/079425 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effectiveness of Yavakshara and Vyoshadi guggulu in patients with Grade 11 Non Alcoholic Fatty Liver Disease NAFLD |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the effectiveness of Yavakshara and Vyoshadi guggulu in the management of Grade 11 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 |
Dr Fathima Nithusha |
| Designation |
PG Scholar |
| Affiliation |
VPSV Ayurveda College kottakkal |
| Address |
Department of Salyatantra
VPSV Ayurveda College kottakkal Edarikode P O Malappuram kerala
India
Malappuram
KERALA
676501
India |
| Phone |
9037988920 |
| Fax |
|
| Email |
fathimanithusha76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunitha PV |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of salyatantra
VPSV Ayurveda College Kottakkal
Malappuram District Kerala
676501
India
Malappuram
KERALA
676501
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunitha PV |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of salyatantra
VPSV Ayurveda College Kottakkal
Malappuram District Kerala
676501
India
Malappuram
KERALA
676501
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arya Vaidya Sala GMP certified institute Kottakkal Edarikode P O Malappuram kerala 676501 India |
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda College Kottakkal |
| Address |
VPSV Ayurveda College Kottakkal Edarikode PO Malappuram Kerala 676501 India |
| Type of Sponsor |
Other [AIDED 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 |
| Dr Fathima Nithusha |
VPSV Ayurveda College Kottakkal |
OP Department of Salyatantra Room 101A Kottakkal Edarikode P O Malappuram kerala 676501 India
Malappuram
KERALA |
9037988920
fathimanithusha76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) VAIDYARATNAM P S VARRIER AYURVEDA COLLEGE KOTTAKKAL |
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: Yavakshara, Reference: susrutha samhitha utharatantra , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi guggulu, Reference: Ashtanaga Hrdaya vatavyadhi cikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of grade 11 fatty liver through usg
Elavated AST and ALT
ALT not greater than 5 times of AST |
|
| ExclusionCriteria |
| Details |
known case of malignancy
unconytrolled DM, HTN
Participants contraindicated for paneeyakshara |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in value of AST and ALT in LFT |
0th and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
21/02/2025 |
| 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 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
|
A comparative clinical trial is planned in Grade 11 Non Alcoholic Fatty Liver (NAFLD) to compare yawith yavakshara and vyoshadi guggulu, will be done among 13 participants in each group of 45 days in the age group of 20-65 years. Participants selected concecutively as per inclusion criteria into two groups from the OPD of VPSV Ayurveda college Kottakkal. Group 1 will be managed with yavakshara capsule 500 mg, twice daily after food. Group 2 will be treated with vyoshadi guggulu 500 mg twice daily after food. Assesment will be done based on blood parameters like AST and ALT on 0th and 45 th day. No special diet modification /life style changes will be advised during this period. |