| CTRI Number |
CTRI/2017/03/008068 [Registered on: 14/03/2017] Trial Registered Prospectively |
| Last Modified On: |
10/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
An open clinical trial of mantharaiver kudineer(internal medicine)for athithoolam(obesity) |
|
Scientific Title of Study
|
An open clinical trial to evaluate the therapeutic efficacy of siddha preparation MANTHARAIVER kudineer in the treatment of athithoolam(obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRKeerthana |
| Designation |
PG scholar |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha,
tambaram, sanatorium
chennai-47
National institute of siddha ,Tambaram,
Sanatorium,
Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9942558818 |
| Fax |
|
| Email |
sugeebsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr s visweswaran |
| Designation |
MD (SIDDHA) |
| Affiliation |
National institute of siddha |
| Address |
Lecturer Department of Gunapadam,National institute of siddha Tambaram Sanatorium Chennai-47
National institute of siddha,tambaram sanatorium Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962542755 |
| Fax |
|
| Email |
svisu11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr s visweswaran |
| Designation |
MD (SIDDHA) |
| Affiliation |
National institute of siddha |
| Address |
Lecturer Department of Gunapadam,National institute of siddha Tambaram Sanatorium Chennai-47
National institute of siddha,tambaram sanatorium Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962542755 |
| Fax |
|
| Email |
svisu11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hospital-National institute of siddha,Tambaram,sanatorium,chennai-600014 |
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
OP Room Number 2 Department of Gunapadam Ayothidoss pandithar hospital National institute of siddha tambaram sanatorium chennai47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRKeerthana |
National institute of siddha hospital |
Op Room Number 2 Department of Gunapadam Ayothidoss pandithar hospital National institute of siddha hospital tambaram sanatorium chennai47
Kancheepuram
TAMIL NADU |
9942558818
sugeebsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National institute of siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary health conditions,preventative or screening |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mantharaiver kudineer |
Drug- MANTHARAIVER KUDINEER
Dosage-60ml empty stomach Morning and evening.
Method of preparation-5g of mantharaiver kudineer powder is mixed in 120 mi of water boil it and untill it becomes 60ml finally the filter the decotion .
Route of administration- oral.
Duration- 3 Month(9O Days)
|
| Intervention |
MANTHARAIVER KUDINEER |
Drug- MANTHARAIVER KUDINEER Dosage-60ml empty stomach Morning and evening. Method of preparation-5g of mantharaiver kudineer powder is mixed in 120 mi of water boil it and untill it becomes 60ml finally the filter the decotion . Route of administration- oral. Duration- 3 Month(9O Days) |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60,
Lipid profile above the normal
BMI- above the normal level |
|
| ExclusionCriteria |
| Details |
chronic kidney disease
pregnancy
presence of any serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced the body weight
To achieve the normal BMI
To observe the any other changes in lipid profile value and other blood parameters |
3 Month(90 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the any other changes in lipid profile value and other blood parameters |
3 Month(90 days) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
20/03/2017 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Many disease are emerging as a trend of lifestlye modifications due to stress sedentary lifestyle and food habits one among them is obesity (athithoolam) the symptoms of Athithoolam are weight gain increased abdominal grith etc it may be correlated with obesity in modern science It is abnormal accumulation of body fat usually 20% or more over an individuals body weight . It is associated with increased risk of illness disability India is the third most obese country in the world not surprisingly the prevelance of obesity appears to be higher from 16 to 29 % over the last five years siddhars mentioned many formulation in treating athithoolam among them MANTHARAIVER KUDINEER mentioned in gunapadam mooligai vaguppu indicated for obesity so i selected this medicine for obesity (Athithoolam) |