| CTRI Number |
CTRI/2025/02/079854 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An interventional Study on selective siddha medicines like seenthil chooranam, inji rasayanam, mandurathi kudineer in the management of kaleeral noi(Alcoholic Liver Disease stage I and stage II) |
|
Scientific Title of Study
|
An open clinical trial to evaluate the effectiveness of selective siddha medicines in the management of kaleeral noi (Alcoholic Liver Disease stage I and stage II) among out patients attending ayothidoss pandithar hospital national institute of siddha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suruthi Balakrishnan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 26/27
Department of nanju maruthuvam
National institute of siddha
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
7904646277 |
| Fax |
044-22381314 |
| Email |
suruthiks19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Manjari |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 26/27
Department of nanju maruthuvam
National institute of siddha
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8056903083 |
| Fax |
044-22381314 |
| Email |
drmanjarimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Manjari |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 26/27
Department of nanju maruthuvam
National institute of siddha
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8056903083 |
| Fax |
044-22381314 |
| Email |
drmanjarimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha tambaram sanatorium Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National Institute of siddha |
| Address |
No 26/27
Department of nanju maruthuvam
National institute of siddha tambaram sanatorium Chennai 47 |
| 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 B Suruthi |
Ayothidass pandithar Hospital |
Room no 26/27
Department of nanju maruthuvam
National institute of siddha
Tambaram sanatorium Chennai 47
Chennai
TAMIL NADU |
7904646277
044-22381314
suruthiks19@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: K700||Alcoholic fatty liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Seenthil chooranam
Inji rasayanam
Mandurathi kudineer |
Seenthil chooranam 2g twice a Day with ghee for 48 days
Inji rasayanam 6g twice a day with warm water for 48 days
Mandurathi kudineer 50ml twice a day for 48days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group: 30-65 years
Gender: All gender
Patient has the history of alcoholic more than 5yrs and who are Alcohol abstinence with ALD included.
Patient having CIWA-Ar scale less than 19 (mild to moderate)
Patient having MDF score less than 32 (mild to moderate)
|
|
| ExclusionCriteria |
| Details |
Pregnancy or lactation
Fasting glucose levels greater than 250 mg per decilitre
Concomitant disease with reduced life expectancy
Hepatic failure
Severe psychiatric conditions
Drug dependence
Patients with known liver diseases such as viral hepatitis, non alcoholic fatty liver, autoimmune disorders, biliary disorder, liver abscess, cirrhosis and malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME:
Reduction in signs and symptoms of alcoholic liver disease will be assessed before and after treatment. |
PRIMARY OUTCOME:
Reduction in signs and symptoms of alcoholic liver disease will be assessed before and after treatment.
SECONDARY OUTCOME:
Changes in Lipid Profile, MDF Score,Fasting Blood Sugar and Liver Function Test will be assessed before and after treatment
Changes in ultrasonography of abdomen(liver)
Changes in waist circumference and Body Mass Index will be assessed before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OUTCOME:
Changes in Lipid Profile, MDF Score,Fasting Blood Sugar and Liver Function Test will be assessed before and after treatment
Changes in ultrasonography of abdomen(liver)
Changes in waist circumference and Body Mass Index will be assessed before and after treatment |
|
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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: Alcoholic liver disease (ALD) is the third most common cause of chronic liver disease, and it has a global burden of mortality(1). The alcoholic liver disease covers a spectrum of disorders beginning from the fatty liver, progressing at times to alcoholic hepatitis and culminating in alcoholic cirrhosis, which is the most advanced and irreversible form of liver injury related to the consumption of alcohol. There are three histologic stages of alcoholic liver disease Alcoholic Fatty Liver or Steatosis ,Alcoholic Hepatitis and Alcoholic Cirrhosis OBJECTIVE:
PRIMARY OBJECTIVE:
• To evaluate the therapeutic effectiveness of siddha herbal and herbo-mineral formulations of “SEENTHIL CHOORANAM, INJI RASAYANAM AND MANDURATHI KUDINEER” in the management of KALEERAL NOI (ALCOHOLIC LIVER DISEASE STAGE I AND STAGE II) by assessment of reduction in signs and symptoms of the alcholic liver disease stage I and stage II among the out patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha.
SECONDARY OBJECTIVE:
• To evaluate the changes in CIWA-Ar scale(20) [Clinical Institute Withdrawal Assessment for Alcohol Revised], Liver Function Test, MDF score(5)[Maddrey Discriminant Function Score],lipid profile and fasting blood glucose of the patients before and after treatment.
• To evaluate the changes in Ultrasonography abdomen(liver)
• To evaluate the changes in Body Mass Index and Waist circumference of the patients before and after treatment.
STUDY DESIGN : An Open Clinical Trial PRIMARY OUTCOME:
• Reduction in signs and symptoms of alcoholic liver disease will be assessed before and after treatment.
SECONDARY OUTCOME:
• Changes in Lipid Profile, MDF Score,Fasting Blood Sugar and Liver Function Test will be assessed before and after treatment
• Changes in ultrasonography of abdomen(liver)
• Changes in waist circumference and Body Mass Index will be assessed before and after treatment
|