| CTRI Number |
CTRI/2024/12/078343 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
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| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Panchakarma procedure and Ayurvedic medicine in the management of Yakrit Vikara w.s.r. to Alcoholic Fatty Liver Disease |
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Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Yakrit-16 Compound- Kwatha and Tablets (Kalpit Yoga) With And Without Kalpit Kalmeghadi Niruha Basti In The Management Of Yakrit Vikara w.s.r. to Alcoholic Fatty Liver Disease |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshay Khanna |
| Designation |
MD Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab-144008 INDIA
Jalandhar
PUNJAB
144008
India |
| Phone |
7889017064 |
| Fax |
|
| Email |
daman.khanna999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Sood |
| Designation |
Professor and HOD of Panchakarma |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab-144008 INDIA
Jalandhar
PUNJAB
144008
India |
| Phone |
9814004142 |
| Fax |
|
| Email |
drsanjeevsood@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Khanna |
| Designation |
MD Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab-144008 INDIA
Jalandhar
PUNJAB
144008
India |
| Phone |
7889017064 |
| Fax |
|
| Email |
daman.khanna999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab-144008 INDIA |
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Primary Sponsor
|
| Name |
Dayanand Ayurvedic College |
| Address |
Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab-144008 INDIA |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshay Khanna |
Dayanand Ayurvedic College, Jalandhar |
Department of Panchakarma, Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab-144008 INDIA
Jalandhar
PUNJAB |
7889017064
daman.khanna999@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutional Ethical Committee |
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:K700||Alcoholic fatty liver. Ayurveda Condition: YAKRUDDALYUDARAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Yakrit-16 Compound Kwatha, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Ingredients present in the drug have reference in Bhavaprakash Nighantu Haritkyadi, Guduchyadi varga(2) Medicine Name: Yakrit-16 Compound Tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Ingredients present in the drug have reference in Bhavaprakash Nighantu Haritkyadi, Guduchyadi varga | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ch.Chi.13/77, Page No. 303, Procedure details: For treating Yakrit Vikara Patients, Basti Karma in Kala regimen will be given i.e. Niruha Basti with Kalpit Kalmeghadi Kwatha in a dose of 350 ml for 6 days and Anuvasana Basti with Murchita Tila Taila in a dose of 60 ml for 10 days. Method:
Poorva Karma 1.First of all, the patient will be subjected to Sathanik Abyanga and Swedan karma on empty stomach. However, patient should not be very hungry. Pradhana Karma: 1.Then for the administration of Basti, the patient will lie on the table in left lateral position with left leg straight and right leg flexed, his head should rest on his left flexed arm. 2.Then the anus and Basti netra will be lubricated with oil. 3.Aushadh dravyas (the therapeutic medication) filled in Basti Putaka will be administered through the anal route with the help of the Basti Netra which will be attached to Basti Putaka. 4.The Aushadh dravya will be administered with constant pressure. 5.At last, the Basti Netra will be taken out of the anus slowly. Paschata Karma: 1.Patient will be asked to lie down with his face upward after getting the urge he will eliminate the faeces sitting on his heels. 2.After defecation patient will be asked to take a bath with warm water and have a light meal)
(1) Medicine Name: Kalpit kalmeghadi Niruha Basti, Reference: Bhava Praksha Nighantu Haritykadi varga, Guduchyadi varga, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: od, Duration: 6 Days(2) Medicine Name: Murchita tila taila, Reference: Bh.Ra.5/1268, Page No. 206, Bhava Prakash Nighantu Haritkyadi Varga, Guduchyadi Varga, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 10 Days |
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Inclusion Criteria
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| Age From |
22.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Randomly selected irrespective of their caste, religion and sex.
b) Voluntary agreement & enrolment to participate in the study.
c) The ratio of AST/ALT below 2.
d) Patients having alterations in Liver function tests with and without the symptoms of Kamala.
e) AFLD diagnosed by abdomen ultrasonic examination of fatty liver changes grade 1 and grade 2 only.
f) History of regular alcohol intake for at least 6 months.
|
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| ExclusionCriteria |
| Details |
a) AFLD diagnosed by abdomen ultrasonic examination of fatty liver changes grade 3 or above.
b) Patients with fatty liver changes due to causes other than alcohol.
c) Patients with other illness such as uncontrolled Type I and II Diabetes Mellitus, Uncontrolled Hypertension, Cerebrovascular Accident, Myocardial Infarction and Chronic Kidney Disease, HIV, Tuberculosis, Malignancies, Major Psychiatric Problems or any other serious problems.
d) Patients having progressive stage of alcoholic liver disease like Hepatitis, Ascites, Cirrhosis, Cancer.
e) Patients on prolonged (more than 6 weeks) medication with corticosteroids, antidepressants, anti- cholinergic, hepato-toxic medicines or any other drug that may influence the outcome of the study.
f) Drug abuser.
g) Pregnant and Lactating women.
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in the clinical symptoms of AFLD:
i. Aruchi (Anorexia)
ii. Avipaka (Indigestion)
iii. Udarshula (Abdominal Pain)
iv. Agnimandya (Diminution of the Agni)
v. Utklesha (Nausea)
vi. Chardi (Vomiting)
|
Assessment will be done in both the groups:
1. DAY 0- At the time of enrollment of the patient
1.DAY 48th-At the end of the treatment (for Group A)
2.DAY 45th-At the end of the treatment (for Group B)
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Secondary Outcome
|
| Outcome |
TimePoints |
Significant Improvement in the objective parameters:
1.Reduction in SGOT
2.Reduction in SGPT
3.Reduction in Alkaline Phosphatase
4.Reduction in GGT
|
Assessment will be done in both the groups:
DAY 0- At the time of enrollment of the patient
DAY 60- At the time of the follow up |
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Target Sample Size
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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" |
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Phase of Trial
|
Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
05/02/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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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
|
In this clinical trail, a total of 60 patients will be selected on the basis of signs and symptoms of Yakrit Vikara (Alcoholic Fatty Liver). These patients will be divided into 2 groups (Group A and Group B). Group A will be given Yakrit-16 Compound Kwatha and Tablets (Kalpit Yoga) and Kalpit Kalmeghadi Niruha Basti. Group B will be given only Yakrit-16 Compound Kwatha and Tablets (Kalpit Yoga). Hence the present study is undertaken to Evaluate the efficacy of Yakrit-16 Compound- Kwatha and tablets (Kalpit Yoga) with and without kalpit kalmeghadi niruha basti in the Management of Yakrit vikara w.s.r. to Alcoholic Fatty Liver Disease. |