| CTRI Number |
CTRI/2024/06/068235 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study In the Management Of Chronic Liver Disease.
|
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Kasisadya Vati In The Management Of Chronic Liver Disease W.S.R To Kumbhakamala. |
| 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. Chepuri Bhargavi |
| Designation |
Post Grasuate In KayaChikitsa. |
| Affiliation |
Dr.BRKR Government Ayurvedic college and hospital. |
| Address |
12-23, Shantha residency,Road no 5 Lane no 4, Sharadha theatre lane, P and T Colony, Dilsukhnagar, Hyderabad.
Room no-3, Division-3.
Dr.BRKR Government Ayurvedic College and Hospital, Erragadda. 500038
Hyderabad
TELANGANA
500060
India |
| Phone |
8639597801 |
| Fax |
|
| Email |
gbhargavih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Swaroopa |
| Designation |
Professor, MD Ayurveda, Department Of KayaChikitsa. |
| Affiliation |
Dr.BRKR Government Ayurvedic college and hospital. |
| Address |
Room no-3,Division Unit No-3,
Dr.BRKR Government ayurvedic College And Hospital, Erragadda.
Hyderabad
TELANGANA
500038
India |
| Phone |
9866275613 |
| Fax |
|
| Email |
swaroopa.kusuma95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Swaroopa |
| Designation |
Professor, MD Ayurveda, Department Of KayaChikitsa. |
| Affiliation |
Dr.BRKR Government Ayurvedic college and hospital. |
| Address |
Room no-3, Division Unit no-3.
Dr.BRKR Government Ayurvedic College and Hospital, Erragadda, Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
9866275613 |
| Fax |
|
| Email |
swaroopa.kusuma95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.BRKR Government Ayurvedic College and Hospital. |
|
|
Primary Sponsor
|
| Name |
Dr Chepuri Bhargavi |
| Address |
12-23, Shantha residency, Road no 5 lane no 4, Sharadha theatre lane, P and T Colony, Dilsukhnagar,Hyderabad.500060 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrChepuri Bhargavi |
Dr.BRKR Government Ayurvedic College and Hospital |
Room no-3, KayaChikitsa OPD, Dr.BRKR Government Ayurvedic College and Hospital, Erragadda.
Hyderabad
TELANGANA |
8639597801
gbhargavih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Of Dr.BRKR Government Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K74||Fibrosis and cirrhosis of liver. Ayurveda Condition: KUMBAKAMALA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fatty Liver Of Grade 1,2,3.
2. Liver Parenchymal Changes With Or Without Hyperbilirubinemia .
3. Alcoholic Or Non-Alcoholic Liver Disease |
|
| ExclusionCriteria |
| Details |
1. Any Viral Infections like Hepatitis-B/A.
2. Hepatorenal Syndrome
3. Hepatopulmonary Syndrome.
4. Hepatic Encephalopathy.
5. Total Bilirubin of Greater than 7mg/dl
6. MELD SCORE Greater than 21
7. Patients who develop Spontaneous Bacterial Peritonitis.
8. Ascitis
9. Diseases Of Gallbladder/ Suffering from Pancreatitis..
10.Liver Stiffness Of Greater than 30kpa |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In Normalizing the Abnormal Liver Enzymes. |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing the Stiffness Of Liver |
90 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)
|
17/07/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gbhargavih@gmail.com].
- For how long will this data be available start date provided 10-06-2024 and end date provided 30-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Chronic liver disease is gradually becoming a public health priority in india.Overall Nonalcoholic fatty liver disease(NAFLD) and Alcoholic liver disease(ALD) are emerging as important cases of Chronic liver disease in the country paralleling the changes in lifestyle and social custom. Regional variabilities of Chronic liver disease are evident in this geographically and ethically diverse country. Hepatitis-B still remains the major cause of Chronic liver disease and cancer. As Chronic liver disease can be correlated with Kumbhakamala which is a pittaja nanatmaja vyadhi, Raktapradoshaja vyadhi and Raktavaha srotovyadhi. As Yakrit and Pleeha are moolas of Raktavaha srotas. Hence this clinical trial is initiated to revalidate the efficacy of kasisadya vati in normalizing the liver enzymes and to minimize the alteration of liver parenchymal cells |