| CTRI Number |
CTRI/2025/01/079443 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma Procedure (Basti Karma) and Ayurvedic Medicine (Giloy Swarasa) In The Management Of Yakrit Vikara W.S.R. To Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Giloy Swarasa With And Without Kaphahara Niruha Basti In The Management Of Yakrit Vikara W.S.R. To Non-Alcoholic Fatty Liver Disease |
| 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 Simranjot Kaur |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar(Punjab), Pin Code - 144008,India
Jalandhar
PUNJAB
144008
India |
| Phone |
7009292142 |
| Fax |
|
| Email |
harnoork878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Sood |
| Designation |
Professor and HOD of Panchakarma |
| Affiliation |
Dayanand Ayrvedic College, Jalandhar |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar(Punjab), Pin Code - 144008,India
Jalandhar
PUNJAB
144008
India |
| Phone |
9814004142 |
| Fax |
|
| Email |
drsanjeevsood@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simranjot Kaur |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar(Punjab), Pin Code - 144008,India
Jalandhar
PUNJAB
144008
India |
| Phone |
7009292142 |
| Fax |
|
| Email |
harnoork878@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar (Pb), Pin Code- 144008,India |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College |
| Address |
Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar (Pb), Pin Code- 144008,India |
| Type of Sponsor |
Private 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 Simranjot Kaur |
Dayanand Ayurvedic College And Hospital |
Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar(Punjab), Pin Code - 144008,India
Jalandhar
PUNJAB |
7009292142
harnoork878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutional Ethical Committee |
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, (2) ICD-10 Condition:K77||Liver disorders in diseases classified elsewhere. Ayurveda Condition: YAKRUDDALYUDARAH, (3) ICD-10 Condition:K758||Other specified inflammatory liverdiseases. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Giloy Swarasa, Reference: Bhavaprakasha Nighantu Guduchyadi Varga, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing for study or trial.
2.Randomly selected irrespective of their caste, religion and sex.
3.Patients within the age group of 18-65 years.
4.Voluntary agreement & enrollment to participate in the study.
5.Patients who are fit for Basti Karma.
6.The ratio of AST/ALT below 2.
7.Patients having alterations in Liver function tests with and without the symptoms of Kamala.
8.Non-alcoholic Fatty Liver Disease diagnosed by abdomen ultrasonic examination of fatty liver changes grade 1 and grade 2 only. |
|
| ExclusionCriteria |
| Details |
1.Patients consuming alcohol.
2.Patients will be excluded from the study if they have chronic diseases such as bronchial
asthma, cushing syndrome, malignancies, cerebrovascular accidents, myocardial
infarction, chronic kidney disease or any liver dysfunction beyond non-alcoholic fatty liver disease. Additionally, patients with HIV, tuberculosis, other infectious diseases,
major psychiatric issues or metabolic syndromes will also be excluded.
3.Prior treatment with any medicine that affects the treatment of Non- Alcoholic Fatty Liver
Disease within 3 months.
4.Patient on prolonged more than 6 weeks medication with corticosteroids, antidepressants,
anticholinergic, hepato-toxic medicines or any other drug that may influence the outcome
of the study.
5.Pregnant and Lactating women will be excluded.
6.The patient has a history of hypersensitivity to the trial drug or any of its ingredients.
7.Drug abusers.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in the clinical symptoms of NAFLD:
1.Aruchi (Anorexia)
2.Avipaka (Indigestion)
3.Udarshula (Abdominal pain)
4.Agnimandya (Diminution of the Agni)
5.Utklesha (Nausea)
6.Chardi (Vomiting)
|
Assessment will be done in both the groups:
1.Day 0:At the time of enrollment.
2.Day 20th:At the end of the Basti (for Group A).
3.Day 48th:At the end of the treatment ( for Group A ).
4.Day 45th:At the end of the treatment ( for Group B ).
5.Day 60:At the time of follow up (for both the Groups A and B). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant Improvement in Objective parameters:
1. Reduction in SGOT.
2. Reduction in SGPT.
3. Reduction in Alkaline Phosphatase.
|
Assessment will be done in both the groups:
1.Day 0:At the time of enrollment.
2.Day 20th:At the end of the Basti (for Group A).
3.Day 48th:At the end of the treatment ( for Group A ).
4.Day 45th:At the end of the treatment ( for Group B ).
5.Day 60th:At the time of follow up (For both the Groups A and B).
|
|
|
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 2 |
|
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="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
|
In this clinical trial, total 60 patients will be selected on the basis of signs and symptoms of Yakrit Vikara (Non- alcoholic Fatty Liver Disease), these 60 patients will be divided into 2 groups (Group A and Group B). Group A will be given Kaphahara Niruha Basti along with oral administration of Giloy Swarasa. Group B will be given only Giloy Swarasa. In this study we will evaluate the efficacy of Giloy Swarasa in the management of Yakrit Vikara w.s.r. to Non-Alcoholic Fatty Liver Disease, To evaluate the efficacy of Kaphahara Niruha Basti followed by oral administration of Giloy Swarasa in the management of Yakrit Vikara w.s.r. to Non-Alcoholic Fatty Liver Disease and To compare the efficacy of Giloy Swarasa with and without Kaphahara Niruha Basti in the management of Yakrit Vikara w.s.r. to Non-Alcoholic Fatty Liver Disease with the aim of formulating an effective treatment module for this disease. Total duration of the study will be 18 months. |