| CTRI Number |
CTRI/2025/02/081092 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trial to evaluate the effectiveness of Siddha formulations in the management of Kalleeral Noi(Alcoholic Liver Disease) among Out Patients attending Ayothidoss Pandithar Hospital |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Trial to evaluate the effectiveness of Siddha formulations in the management of Kalleeral Noi(Alcoholic Liver Disease) among Out Patients attending Ayothidoss Pandithar Hospital |
| 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. J.Jinavani |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No.26/27, Department of Nanju Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai.
600047
TAMILNADU
INDIA
Chennai
TAMIL NADU
600047
India |
| Phone |
8072478787 |
| Fax |
|
| Email |
jinajeeva24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S. Murugesan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No-26/27,Department of Nanju Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai - 600047,
Tamil Nadu,
India.
Chennai
TAMIL NADU
600047
India |
| Phone |
9841108269 |
| Fax |
|
| Email |
ss.drss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. S. Murugesan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No.26/27, Department of Nanju Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai-600047,
Tamil Nadu,
India.
Chennai
TAMIL NADU
600047
India |
| Phone |
9841108269 |
| Fax |
|
| Email |
ss.drss@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram Sanatorium,
Chennai - 600047. |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai-600047
TamilNadu |
| 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 J Jinavani |
National Institute of Siddha |
Room No.26/27, Department of Nanju Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai - 600047,
Tamil Nadu.
INDIA
Chennai
TAMIL NADU |
8072478787
jinajeeva24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NATIONAL INSTITUTE OF SIDDHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K70||Alcoholic liver disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Thaalisathi Chooranam & Vediannabethi Chenduram |
Internal Medicines :
1.Thaalisathi Chooranam - 2 gm, bd, after food with Honey.
2.Vediannabethi Chenduram - 130 mg, bd, after food with Honey.
Treatment Duration - 40 Days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
History of Alcoholic Abuse for more than five years and the Alcoholic dependency will be confirmed by AUDIT questionnaire
Subjects who are willing to quit Alcohol
Participants with clinical signs and symptoms of early stages of Alcoholic Liver Disease that confirmed with USG.
Individuals with elevated Liver enzymes Total bilirubin Direct and Indirect Bilirubin
levels such as AST,ALT,ALP, GGT and lipid profile
Patients with an MDF score of less than 32 |
|
| ExclusionCriteria |
| Details |
Individuals with advanced stages of Alcoholic liver disease with MELD score of greater than 20
Withdrawal symptoms like seizure , Alcohol Withdrawal Delirium and Alcohol Hallucinosis
Substance abuse other than alcohol like Narcotics
Pregnant and Lactating women
participants with known liver diseases such as inherited metabolic causes
Hemochromatosis Wilsons disease Hepatic infection and hepatic carcinoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Therapeutic effectiveness of Siddha formulations will be evaluated by observing improvement in clinical signs and symptoms after treatment. |
Screening Period: 2 Months
Trial period: 14 months
Assessment Period:2 Months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Monitoring the changes in the MDF score & MELD SCORE, Lab parameters including LFT (Serum Bilirubin, AST, ALT, ALP, GGT), & lipid profile with its permissible limit after treatment.
Observing the changes in hematological, liver, & renal functional markers will ensure the safety of the trial drugs. |
Screening period: 2 months
Trial period: 14 months
Assessment period:2 months |
|
|
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)
|
21/02/2025 |
| 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
|
BACKGROUND : Alcohol is a direct hepatotoxin, and its ingestion causes the initiation of numerous metabolic responses that influence the final Hepatotoxic response. Alcoholic Liver Disease (ALD) is one of the deadliest diseases that impacts about 5.3% of Global deaths, especially in men with a high death rate and a Global burden of 5.1%. Current management of Alcoholic Liver Disease includes steroidal medication, Nutritional supplements, and abstinence from alcohol. These drugs develop resistance and troublesome side effects in patients. The rationale behind this study is to mitigate the symptoms of ALD using the Siddha formulation.
AIM: To evaluate the clinical effectiveness of Siddha formulations Thaalisathi Chooranam and Vediannabethi Chenduram in the management of Kalleeral Noi (Alcoholic Liver Disease) at early stages among patients reporting at Ayothidoss Pandithar Hospital.
OBJECTIVES : PRIMARY OBJECTIVE : To evaluate the clinical effectiveness of Siddha formulations by observing changes in signs and symptoms of the patient before and after treatment.
SECONDARY OBJECTIVE : - To evaluate the changes in MDF score ,Lab parametes - LFT (Serum Bilirubin, AST, ALT, ALP, GGT) and Lipid profile before and after treatment.
- To evaluate the changes in Liver function by comparing the MELD score ( Serum Total Bilirubin, Serum Creatinine and INR ratio) before and after treatment.
- To ensure patient safety by monitoring Liver Function Test ( LFT),Renal Function Test (RFT) and Hematological parameters before and after treatment.
STUDY DESIGN : An open-Label single arm Clinical Trial
INTERVENTIONAL DRUGS :
I)Thaalisathi Chooranam : Dosage : 2 grams Regimen : BD (Twice in a day ),after food Adjuvant : Honey
II) Vediannabethi Chenduram : Dosage : 130 mg Regimen: BD (Twice in a day ),after food Adjuvant : Honey
TREATMENT PERIOD : 40 days
EXPECTED OUTCOME : - The therapeutic effectiveness of Siddha formulations will be evaluated by observing the improvement in clinical signs and symptoms after treatment.
SECONDARY OUTCOME : - Monitoring the changes in the MDF score and MELD score, Lab parameters ( LFT - Serum Bilirubin,AST,ALT,ALP,GGT), and Lipid profile with its permissible limit after treatment.
- The safety of the trial drugs will be ensured by observing the changes in Haematological parameters and lipid and Renal function markers.
|