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A clinical trial to study the effect of the drug Kamalaiku kashayam in patients having Vali manjal noi(Fatty Liver Disease)

Phase 2
Not yet recruiting
Conditions
Type 2 diabetes mellitus with other specified complications,
Registration Number
CTRI/2021/10/037674
Lead Sponsor
Government Siddha Medical college
Brief Summary

This is a single non randomised open clinical trial to study the safety and efficacy of siddha trial drug Kamalaiku kashayam. The trial drug is given 30ml twice a day for 30 days. Clinical trial is conducted after conducting the preclinical toxicity study. The trial drug Kamalaiku kashayam is mentioned in Sikicha rathna deepam. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

Subject within 20-60years, Grade 2 & Grade 1 fatty liver in USG abdomen Metabolic syndrome(Type 2 Diabetes mellitus,Obesity) Dyslipidemia.

Exclusion Criteria

Cirrhosis HCC Alcoholic fatty liver Portal hypertension Hepatitis (HBV,HCV infection) Hepatosplenomegaly Cholecystitis.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
It is mainly assessed by reduction in the clinical symptoms of abdominal discomfort, fat deposition, fatigue and abdominal pain90days
Secondary Outcome Measures
NameTimeMethod
By comparing the fat deposition changes assessed by USG abdomen Grade 2 to Grade 1, Grade 1 to normal in liver USG study before and after treatment.30days

Trial Locations

Locations (1)

Arignar Anna Government hospital of Indian Medicine

🇮🇳

Chennai, TAMIL NADU, India

Arignar Anna Government hospital of Indian Medicine
🇮🇳Chennai, TAMIL NADU, India
DrKuttala vadivu C
Principal investigator
9361325072
vadivubala1995@gmail.com

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