CTRI

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CTRI Number

CTRI/2024/06/068237 [Registered on: 03/06/2024] Trial Registered Prospectively

Last Modified On:

31/05/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Siddha

Study Design

Single Arm Study

Public Title of Study

Study on Pidangunari Kudineer Chooranam for Non Alcoholic Fatty Liver Disease (NAFLD)

Scientific Title of Study

Efficacy of Pidangunari kudineer chooranam for Non_Alcoholic Fatty Liver Disease (NAFLD) among patients attending OPD at Government Siddha medical college Hospital, Chennai_A pilot study

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 S Kowsalya
Designation	PG Scholar
Affiliation	Government Siddha Medical College, Chennai
Address	Department of PG Pothu Maruthuvam, OPD No:S1, Government Siddha Medical College, Arumbakkam, Chennai. Chennai TAMIL NADU 600106 India
Phone	9500948315
Fax
Email	kowsalyasivabsms98@gmail.com

Details of Contact Person
Scientific Query

Name	Dr K Kanakavalli
Designation	Professor, Department of PG Pothu Maruthuvam
Affiliation	Government Siddha Medical College, Chennai
Address	Department of PG Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai. Chennai TAMIL NADU 600106 India
Phone	9444122865
Fax
Email	drkkanakavalli@gmail.com

Details of Contact Person
Public Query

Name	Dr K Kanakavalli
Designation	Professor, Department of PG Pothu Maruthuvam
Affiliation	Government Siddha Medical College, Chennai
Address	Department of PG Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam,Chennai. Chennai TAMIL NADU 600106 India
Phone	9444122865
Fax
Email	drkkanakavalli@gmail.com

Source of Monetary or Material Support

Government Siddha Medical College,No-6,Anna Arch Road, Arumbakkam,Chennai-600106.

Primary Sponsor

Name	Government Siddha Medical College Chennai
Address	No-6,Anna Arch Road, Arumbakkam,Chennai_106.
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr S Kowsalya	Government Siddha medical college, Chennai	OPD No:1, Government Siddha medical college ,Arumbakkam, Chennai_600106 Chennai TAMIL NADU	9500948315 kowsalyasivabsms98@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Government Siddha Medical College, Arumbakkam, Chennai	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E00-E89\|\|Endocrine, nutritional and metabolic diseases,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Nil	Nil
Intervention	Pidangunari Kudineer Chooranam	Pidangunari kudineer chooranam_To make decoction boil 12gms of this powder with 250ml of water , till it reduced to 60 ml. Dosage_60 ml,twice a day. Duration for 90 days.

Inclusion Criteria

Age From	30.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Subjects having complaints of pain or discomfort in the right upper quadrant/epigastric region of the abdomen, nausea, vomiting, indigestion, anorexia ,fatigue, bloating and distension. Obese subjects. Metabolic syndrome(T2DM,dyslipidaemia). Grade I,II, fatty liver in USG abdomen.

ExclusionCriteria

Details

Patients with Chronic Kidney Disease, Cardiovascular Disease.
Patients with known liver diseases such as viral hepatitis, biliary disorder, liver abscess, cirrhosis and malignancy.
Patients in vulnerable group such as Pregnancy,lactation.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy of Pidangunari kudineer chooranam in Non_alcoholic fatty liver disease (NAFLD)by improvement in grades of fatty liver	90 days

Secondary Outcome

Outcome	TimePoints
Reduction in values of lipid profile and LFT will be assessed before and after Treatment Improvement in the symptoms of NAFLD before and after treatment.	90 days

Target Sample Size

Total Sample Size="10"
Sample Size from India="10"
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)

15/06/2024

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="0"
Months="3"
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

Non_alcoholic fatty liver disease(NAFLD) is a spectrum of disease characterized by accumulation of fat or steatosis in liver cells in the absence of other identicable causes such as Alcohol consumption.It includes simple fatty liver, NASH fibrosis and cirrhosis with a complex multi-hit pathophysiology. The initiating events in NAFLD is increased hepatic free fattyacid reflux. The imbalance between the rate of import/synthesis and the rate of export/catabolism of fatty acids in the liver leads to the development of steatosis.so it is considered to evaluate the efficacy of Siddha medicine Pidangunari kudineer chooranam in treating Non-alcoholic fatty liver disease.The study is designed to access the improvement of the patient from grade II to grade I in USG abdomen before and after treatment.