| CTRI Number |
CTRI/2026/01/101430 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sharpunkha churna and Sharpunkhadi churna in the management of Yakrit Vikara |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy of Sharpunkha churna and Sharpunkhadi churna in the management of Metabolic Dysfunction- Associated Fatty Liver Disease (~Yakrit Vikara) |
| 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 Amreen |
| Designation |
MD Scholar |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 108 Department of Kayachikitsa Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar Njafgarh South west Delhi 110073 India
New Delhi
DELHI
110073
India |
| Phone |
9716916597 |
| Fax |
|
| Email |
amykhan6797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr Yogesh Kumar Pandey |
| Designation |
Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar Njafgarh South west Delhi 110073 India
New Delhi
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr Yogesh Kumar Pandey |
| Designation |
Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar Njafgarh South west Delhi 110073 India
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch. Brahm Prakash Ayurved Charak Sansthan khera dabar Najafgarh south west New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan khera dabar Najafgarh south west New Delhi India 110073 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Amreen |
Ch. Brahm Prakash Ayurved Charak Sansthan |
Room no 108 Department of Kayachikitsa Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar Njafgarh South west Delhi 110073 India
New Delhi
DELHI |
9716916597
amykhan6797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ch. Brahm Prakash Ayurved Charak Sansthan |
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: Sharpunkha churna, Reference: chakradatta pleeha yakrit chikitsa adhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -cow butter milk), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: sharpunkhadi churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with NFS -1.455 or greater than -1.455.
2.Patient with positive clinical history of Metabolic Dysfunction- Associated Fatty Liver Disease Grade 1 and Grade 2.
3.Patient with classical symptoms suggesting of NAFLD/ Yakrit vikara that is Udarshool (pain in right upper quadrant/ epigastric region of the abdomen), Hrullas (feeling of nausea and vomiting), Arochak (loss of appetite), Klama (fatigue), Koshtha Dah (burning sensation in the abdomen).
4.Patient having age between 25 to 60 years with irrespective of gender.
5.Subject who are able to take medicine orally.
6.Subject who are willing to sign consent.
7.Patient with LFT showing raised ALT (Alanine transaminase level approximately more than 1.5 times the normal limit with/ without raised lipid profile and fasting blood glucose level within normal limit).
|
|
| ExclusionCriteria |
| Details |
1.Patient with history of alcohol intake.
2.Pregnant and lactating female.
3.Patient with positive markers of other liver diseases such as viral hepatitis, autoimmune hepatitis, Wilson’s disease.
4.Subject with concomitant hepatotoxic and anti-dyslipedemic drugs.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in primary assessment criteria i.e NAFLD fibrosis score. |
8 weeks and 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the level of-
1.SGPT
2.SGOT
3.AST/ ALT ratio
4.BMI
5.IFG
6.Sr. Triglyceride
7.S. Albumin
|
8 weeks & 4 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) is an umbrella term for theliver diseases that are characterized primarily by storage of excess macro vesicular fat (>5% of the hepatocytes) because of a perturbation of the homeostatic mechanism that regulate thesynthesis versus utilization of fat in the liver. It show symptoms of Udarshool (right upper quadrant/ epigastric region of the abdomen)Hrullas (feeling of nausea and vomiting)Aruchi (loss of appetite) Klama (fatigue) Koshtha Daah (Burning sensation of abdomen).The prevalence of Metabolic Dysfunction- Associated Fatty Liver Disease in
India is estimated to be 9% and 32% of general population.With a greater frequency
among individuals who are overweight or obese and those who have diabetes or pre-diabetes.The present study aims to evaluate the role of sharpunkha churna and sharpunkhadi churna in reduction
in the primary assessment parameter i.e. NAFLD fibrosis score. total number of patients are 64, 32 in each group. in Group A, Sharpunkha Churna will be only administered at the dose of 3gm twice a day with Cow butter milk (100ml) 2 hours before meal. in Group B, Sharpunkhadi Churna will be only administered at the dose of 3gm twice a day with luke warm water 2 hours before meal. The design of study is Single centered, Open labelled, Randomised Comparative, Interventional study.
[i] Prajakta Ankur Vangurmekar, Agnelo
Mnino Ferreir. Prevalence of non-alcoholic fatty liver (MAFLD)among adults in
uban Goa. NMJI2022 36(6);401-404
|