| CTRI Number |
CTRI/2025/03/081550 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find the role of sudarshan ghanvati and aarogyavardhini vati in Non alcoholic fatty liver disease patients |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Sudarshan ghanvati and
Aarogyavardhini Vati in disintegration of pathogenesis of non-alcoholic
fatty liver disease- A Randomized control trial |
| 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 Umesh Kumar Sapra |
| Designation |
Assistant Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no.-214, PG Department of Rog Nidan Evum Vikriti Vigyan, chaudhary Brahm prakash Ayurved Charak Sansthan,Khera Dabar, NEW DELHI
South West
DELHI
110073
India |
| Phone |
8588943505 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prahlad Kumar Prajapati |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no.-143, PG Department of Rog Nidan Evum Vikriti Vigyan, chaudhary Brahm prakash Ayurved Charak Sansthan,Khera Dabar, NEW DELHI
South West
DELHI
110073
India |
| Phone |
9993812112 |
| Fax |
|
| Email |
prhld230@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prahlad Kumar Prajapati |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no.-143, PG Department of Rog Nidan Evum Vikriti Vigyan, chaudhary Brahm prakash Ayurved Charak Sansthan,Khera Dabar, NEW DELHI
South West
DELHI
110073
India |
| Phone |
9993812112 |
| Fax |
|
| Email |
prhld230@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, New Delhi, India.-110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan,
Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi, India. 110073 |
| Type of Sponsor |
Other [Government Ayurvedic 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 |
| Dr Prahlad kumar Prajapati |
Ch.Brahm Prakash Ayurved Charak Sansthan |
Room no.143 Rog Nidan Evum Vikriti Vigyan Department, chaudhary Brahm prakash Ayurved Charak Sansthan,Khera Dabar
South West
DELHI |
09993812112
prhld230@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aarogyavardhani vati, Reference: Bhaishajya ratanavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: sudarshan ghanvati, Reference: bhaishajya ratanavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender between age of 21 to 65 years.
2. Diagnosed patients of NAFLD grade 1 and grade 2.
3. Patients willing to provide consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mothers.
2. Patients with serious cardiac or renal disorders.
3. Drug induced serious illness.
4. Patients suffering from Cirrhosis of liver. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. USG - Whole Abdomen
|
day0,day45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
secondary Outcome
1. Liver Function tests |
0day,day 45 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/03/2025 |
| 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="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
|
Non-alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease worldwide. NAFLD is a spectrum of the disease characterized by hepatic steatosis when no other causes for secondary hepatic fat accumulation (e.g., excessive alcohol consumption) can be identified. Total 60 patients will be enrolled in two groups of Sudarshan ghanvati and Aarogyavardhini vati and will be treated for 45 days. |