| CTRI Number |
CTRI/2021/10/037674 [Registered on: 29/10/2021] Trial Registered Prospectively |
| Last Modified On: |
29/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of the drug Kamalaiku kashayam in patients having Vali manjal noi(Fatty Liver Disease) |
|
Scientific Title of Study
|
Phase 2 Non randomized open clinical evaluation of siddha medicine Kamalaiku kashayam for the management of Vali manjal noi(Fatty 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 |
DrKuttalavadivu C |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical college |
| Address |
Post Graduate Department of General Medicine,
Government Siddha Medical College ,Arumbakkam , Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9361325072 |
| Fax |
|
| Email |
vadivubala1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMenaka R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate Department of General Medicine, Government Siddha Medical college, Arumbakkam, chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMenaka R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate Department of General Medicine, Government Siddha Medical college, Arumbakkam, chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical college , Arumbakkam, Chennai 106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical college |
| Address |
Government Siddha Medical College, Arumbakkam ,
Chennai-106 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrKuttala vadivu C |
Arignar Anna Government hospital of Indian Medicine |
Room no 2, Post Graduate Department of General Medicine
Chennai
TAMIL NADU |
9361325072
vadivubala1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kamalaiku kashayam |
30ml ,twice a day for 30 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject within 20-60years,
Grade 2 & Grade 1 fatty liver in USG abdomen
Metabolic syndrome(Type 2 Diabetes mellitus,Obesity)
Dyslipidemia |
|
| ExclusionCriteria |
| Details |
Cirrhosis
HCC
Alcoholic fatty liver
Portal hypertension
Hepatitis (HBV,HCV infection)
Hepatosplenomegaly
Cholecystitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by reduction in the clinical symptoms of abdominal discomfort, fat deposition, fatigue and abdominal pain |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |