| CTRI Number |
CTRI/2023/03/050399 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
25/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trial to study the effect of Kaasani Churna in Yakritodara w.s.r to Non Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
An Aetiopathological Study of Yakritodara with Special Reference to Non Alcoholic Fatty Liver Disease and an Upashayatmaka Study to Evaluate the Efficacy of Kaasani Churna |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Basant Kumar Thakur |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Patna 03 Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 03 Bihar
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 03 Bihar
Patna
BIHAR
800003
India |
| Phone |
7004568326 |
| Fax |
|
| Email |
drbkthakur@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basant Kumar Thakur |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Patna 03 Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 03 Bihar
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 03 Bihar
Patna
BIHAR
800003
India |
| Phone |
7004568326 |
| Fax |
|
| Email |
drbkthakur@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basant Kumar Thakur |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Patna 03 Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 03 Bihar
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 03 Bihar
Patna
BIHAR
800003
India |
| Phone |
7004568326 |
| Fax |
|
| Email |
drbkthakur@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Patna 03 Bihar |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar 800003 |
| 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 Manmath kumar |
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar 800003 |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar 800003
Patna
BIHAR |
8002520899
gsofram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kaasani, Reference: Dravyaguna Vigyan volume 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
Kaasani is one of the best effective drug that acts on liver
The properties of Kaasani is Laghu Ruksha Tikta Katu Ushna
Karma Deepan Yakritouttejaka Pittasaraka Trishananigrehana
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 20 years and below 60 years
Patients of both sexes will be taken
Patients present with sign and symptoms of Yakritodara
Patients present with sign and symptom of Non Alcoholic Fatty Liver Disease |
|
| ExclusionCriteria |
| Details |
Age less than 20 years and above 60 years
Enlargement of Yakri other than Yakritodara or Non Alcoholic Fatty Liver Disease
Pregnent and Lactating women
Immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in fat buildup in the liver |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief of symptoms like
Weakness
Dyspepsia
Thirst
Abdominal distension
Abdominal discomfort
Emaciation
Anorexia |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
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 is excessive fat buildup in the liver without another clear cause such as alcohol use. There is no direct reference of Non alcoholic fatty liver disease in Ayurvedic classics, but it can be correlated with Yakritidara. kaasani is the drug that is mention in Ayurvedic text, taken in the trial and hope may be effective in Non alcoholic fatty liver disease. As drug is chief may be fruitfull in poor people. The duration of trial will be 60 days. Patient will be taken from OPD and IPD of Government Auyrvedic College Patna and other authorized hospital. |