| CTRI Number |
CTRI/2023/06/053504 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Venthamarai chooranam & yoga for hyperlipidemia |
|
Scientific Title of Study
|
A comparative clinical trial on venthamarai chooranam with & without yogasanam for the management of athimetham (Hyperlipidemia) patients reporting at Ayothidoss pandithar hospital of National Institute of Siddha, chennai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Swathi |
| Designation |
PG Scholar |
| Affiliation |
PG Scholar |
| Address |
Department of Siddhar yoga maruthuvam
OPD Number 13
National Institute of Siddha
Chennai
Department of Siddhar Yoga Maruthuvam
OPD Number 13
National Institute of Siddha
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9655135040 |
| Fax |
|
| Email |
bsmsswathi12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V MAHALAKSHMI |
| Designation |
Associate professor |
| Affiliation |
PG Scholar |
| Address |
Department of Siddhar yoga maruthuvam
OPD Number 13
National Institute of Siddha
Chennai
Department of Siddhar yoga maruthuvam
OPD Number 13
National Institute of Siddha
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Swathi |
| Designation |
PG Scholar |
| Affiliation |
PG Scholar |
| Address |
Department of Siddhar yoga maruthuvam
OPD Number 13
National Institute of Siddha
Chennai
Department of Siddhar yoga maruthuvam
OPD Number 13
National Institute of Siddha
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
|
| Fax |
|
| Email |
bsmsswathi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
Chennai
600047 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 S Swathi |
National Institute of Siddha |
Department of Siddhar Yoga Maruthuvam
OPD number 13
National Institute of Siddha
Chennai 47
Chennai
TAMIL NADU |
9655135040
bsmsswathi12@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: E784||Other hyperlipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Internal medicine
Venthamarai chooranam 1-2gram with hot water twice a day after food |
Venthamarai chooranam 1-2gram with hot water
twice a day after food |
| Comparator Agent |
NIL |
NIL |
| Intervention |
YOGASANAM |
Relaxation techniques
Padhahasthasanam
Vajrasanam
Bhavanamukthasanam
Bhujangasanam
Utthanpadasanam
Santhi asanam
Nadisuthi pranayamam |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients satisfying any one of the following criteria
Serum total cholesterol (above 200mg/dl)
Serum triglycerides (above 150mg/dl)
Low density lipoprotein (above 100mg/dl)
Patients who are willing to provide blood for investigation before and after treatment
Patient willing to sign in the consent form
Patients who are willing to attend OPD once in 7 days
|
|
| ExclusionCriteria |
| Details |
Chronic renal failure
Liver disorder
Pregnancy and lactation
Drug induced obesity
Cardiac vascular disease
Malignancy
Neurological disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study will be assessed by reduction in the lipid levels after treatment |
The outcome of the study will be assessed by a reduction in lipid levels after 90 days of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2023 |
| Date of Study Completion (India) |
07/10/2024 |
| Date of First Enrollment (Global) |
15/06/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
will be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hyperlipidemia is one among the lifestyle modification disorders Hyperlipidemia means an increase in total cholesterol level which forms the base for many diseases such as coronary heart disease stroke In the siddha concept it may be correlated to the Athimetham It is mainly due to lifestyle modification unhealthy eating habits less physical activity medical health disorder under any medication Hence considerably more patients of Athimetham have been recorded in the Ayothiyadoss pandithar hospital The Siddha polyherbal formulation Venthamarai chooranam is said to be cost effective and simple formulation Most of the ingredients of venthamarai chooranam have the antioxidant anti hypertensive and hypolipidemic activity Major causes for hyperlipidemia are sedentary lifestyle unhealthy eating habits stress and obesity The improvement in lipid profile with practice of yoga is due to increased hepatic lipase and lipoprotein lipase This would increase the uptake of triglycerides by adipose tissue and affect the lipoprotein metabolism Yogasanam plays an important role in the management of cholesterol levels So I hope Venthamarai chooranam and yogasanam will be effective in the treatment of Athimetham (Hyperlipidemia) |