| CTRI Number |
CTRI/2023/07/054967 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Open Label Single Arm Clinical Study To Evaluate The Combined Effect of Virechana And Trayantyadi Kashaya In Alcoholic Liver Disease
|
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study To Evaluate The Combined Effect of Virechana And Trayantyadi Kashaya In Alcoholic Liver Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakshith M M |
| Designation |
PG SCHOLAR |
| Affiliation |
JSS Ayurveda Medical college |
| Address |
Department of Kayachikitsa
OPD 1
41/E JSS Ayurveda Medical College Lalithadripura road Alanahalli Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
8951051997 |
| Fax |
|
| Email |
rakshithparashar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa C Patil |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical college |
| Address |
Department of PG studies in Kayachikitsa 41/E JSS Ayurveda Medical College Lalithadripura road Alanahalli Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
9886485005 |
| Fax |
|
| Email |
deepsmysore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakshith M M |
| Designation |
PG SCHOLAR |
| Affiliation |
JSS Ayurveda Medical college |
| Address |
Department of PG Studies in Kayachikitsa OPD 1,41/E JSS Ayurveda Medical College Lalithadripura road Alanahalli Mysore
KARNATAKA
570028
India |
| Phone |
8951051997 |
| Fax |
|
| Email |
rakshithparashar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College #41/ E, Lalithadripura Road, Mysuru, Karnataka 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Rakshith MM |
| Address |
41/ E Lalithadripura Road Mysuru Karnataka 570028 |
| 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 |
| Dr Rakshith M M |
Jss Ayurveda Medical College |
41/ E Lalithadripura Road Mysuru Karnataka 570028
Mysore
KARNATAKA |
8951051997
rakshithparashar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JssAyurveda Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K709||Alcoholic liver disease, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka chikitsa stana chapter 16 sloka No 39 40, Procedure details: Virechana for 13 to 17 days)
(1) Medicine Name: TrayantyadiKashaya, Reference: Ashtanga Hridaya chikitsa chapter 13 sloka no 11, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: tds, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.subjects having Alcohol dependence 1 year or more
2.Subjects full filling the diagnostic criteria
3.Subjects with or with out raised billirubin levl (0.1-10 mg/dl )
4.Subjects not suffering from Alcoholic withdrawal symptoms
5.Subjects between the age group of 20-60 years irrespective of gender
6.Subjects with elevated LFT values |
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed with HIV, HBV, Tuberculosis, Myocardial infarction, other systemic diseases which interfere with the course of treatment.
2.Subjects diagnosed with Cirrhosis of liver, Ascites, Viral hepatitis, Severe Alcoholic Hepatitis, and other Psychiatric diseases which interfere with the course of treatment.
3.Subjects diagnosed with other Psychoactive drug dependance.
4.Subjects under active administration of hepato-toxic drugs.
5.Pregnant Women and Lactating Mothers.
6.Subjects not fit for Virechana. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the LFT Values |
Pre-test: 0th day.
Post-test- After treatment: (Shamanaushadhi) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the Ultrasound of Abdomen |
Pre-test: 0th day.
Post-test- After treatment: (Shamanaushadhi) |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/07/2023 |
| 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="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Alcoholic associated Liver Disease (ALD) comprise a spectrum of diseases associated with chronic Alcohol consumption ranging from Alcohol associated Fatty Liver Disease and Steatohepatitis (Alcoholic Hepatitis) to move advanced liver diseases including from fibrosis to cirrhosis.A high daily intake of Alcohol (>60g) in males and (>20 g) in females taken for more than 6 to 8 years, significantly increases the risk of ALD Alcoholic Fatty Liver is the earliest change and is almost universally present in heavy alcoholics. Among the Alcoholic Fatty Liver, 34.3% may end up with Cirrhosis. It is generally a benign condition with abstinence . Alcoholic Hepatitis occurs in 10% to 35% of heavy drinkers who develop necro inflammation with or without fat infiltration. Virechana is the first line of management for Pitta, Pittakapha, and Pittashayagata vikara.Trayantyadi Kashaya include Trayanti as one of the main ingredient which is directly indicated in Yakrit Vikaras as mentioned in Priyanighantu. So present study an effort has been put forth to evaluate efficacy of Virechana and Trayantyadi Kashaya in Alcoholic liver disease.
|