| CTRI Number |
CTRI/2024/06/068380 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to determine the effectiveness of Veppampoo Maathirai in the management of deepana silethma noi (dyslipidemia) |
|
Scientific Title of Study
|
A prospective open labelled,single arm,non-randomized,single centric, phase II,clinical trial to determine the effectiveness of veppampoo maathirai in the management of deepana silethma noi (dyslipidemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAKATHI R |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Op number 10, PG Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital, Thiruvananthapuram main road, Palayamkottai,Tirunelveli-627002, Tamilnadu, India
Government Siddha Medical College and Hospital Thiruvananthapuram main road Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7010264598 |
| Fax |
|
| Email |
Prakathi131998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subash Chandran |
| Designation |
Associate professor |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Op number 10, PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital,Thiruvananthapuram main road,Palayamkottai-627002,Tirunelveli,Tamilnadu, India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9345600723 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli Alias Mehala |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Op number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Thiruvananthapuram main road,Palayamkottai-627002,Tirunelveli, Tamilnadu, India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD facilities and central library of Government Siddha Medical College,Thiruvananthapuram main road,palayamkottai,Tirunelveli-627002,Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
PG department of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Thiruvananthapuram main road, Palayamkottai,Tirunelveli-627002, Tamilnadu, India |
| 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 |
| Dr R Prakathi |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Thiruvananthapuram main road palayamkottai Tirunelveli 627 002
Tirunelveli
TAMIL NADU |
7010264598
Prakathi131998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government siddha medical college and hospital, Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Veppampoo Maathirai |
1 to 2 Pills (Twice a day orally) Before food for 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of primary dyslipidemia
2.TC above 200 mg /dl,LDL above 130mg/dl,VLDL above 30mg/dl,TG above 200mg/dl
3.Having not taking any Lipid Lowering Drugs within the past 1 month
4.Able to adhere to long term treatment
5.Willing and able to follow the scheduled visit plan, diet and exercise instructions, laboratory tests,and other procedures
6.Having voluntarily given their informed consent |
|
| ExclusionCriteria |
| Details |
1.History of CAD/ CVA within the past 4 weeks
2.Combined with nephrotic syndrome, or renal insufficiency
3.Combined with poorly controlled hypothyroidism or other endocrine disease
4.Combined with severe or active liver diseases
5.Combined with severe or any other life threatening disease
6.Allergy to component of the product or allergic constitution
7.Combined with mental disorders
8.Participated in clinical trials of other drugs in the past 4 weeks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the clinical effectiveness of Veppampoo Maathirai (internal) in the management of Deepana silethma noi(Dyslipidemia) and to evaluate the change in LDL from baseline to week 12 |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various aspects of Deepana silethma noi in Siddha literatures.
2.To evaluate physico chemical,phyto chemical and bio chemical characters of Veppampoo maathirai.
3. To evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Veppampoo maathirai.
4.To evaluate pharmacological analysis of Veppampoo maathirai .
5.Study about the prevalence of Deepana silethma noi in relation between diet and life style.
6.To evaluate siddha parameters (including Envagai thervu) changes and dhegi in Deepana silethma noi during the study period.
7. To evaluate modern parametric changes in Deepana silethma noi.
8.To document the Bio statistical analysis.
9. To assess the Quality of life of Deepana silethma noi patients. |
6 months |
|
|
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)
|
25/06/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a A prospective open labelled, single arm,non randomized, single centric,phase II,clinical trial to determine the effectiveness of Veppampoo Maathirai in the management of Deepana silethma noi (Dyslipidemia). After purification of trial drugs, Veppampoo maathirai will be prepared and administered for 3 months for 40 Deepana silethma noi patients ( 20 OP and 20 IP Patients). The primary outcome will be to determine the clinical effectiveness of Veppampoo Maathirai (Internal) in the management of Deepana silethma noi (Dyslipidemia) and to evaluate the change in LDL from baseline to week 12. The secondary outcome will be to collect various aspects of Deepana silethma noi in Siddha literatures, to evaluate physico chemical,phyto chemical and bio chemical characters of Veppampoo maathirai, to evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Veppampoo maathirai, to evaluate pharmacological analysis of Veppampoo maathirai, to study about the prevalence of Deepana silethma noi in relation between diet and life style, to evaluate siddha parameters (including Envagai thervu) changes and dhegi in Deepana silethma noi during the study period, to evaluate modern parametric changes in Deepana silethma noi, to document the Bio statistical analysis, to assess the Quality of life of Deepana silethma noi patients. |