| CTRI Number |
CTRI/2019/05/019475 [Registered on: 31/05/2019] Trial Registered Prospectively |
| Last Modified On: |
30/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of ayurveda in obesity |
|
Scientific Title of Study
|
COMBINED EFFECT OF UDVARTANA AND NITYA VIRECHANA WITH LIFESTYLE MODIFICATION IN OBESITY A RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
UNVLSMO |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Upasna Thakur |
| Designation |
PG Scholar |
| Affiliation |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA |
| Address |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAVI
Belgaum
KARNATAKA
590003
India |
| Phone |
7018767899 |
| Fax |
|
| Email |
upasna19july4019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep L Grampurohit |
| Designation |
Reader |
| Affiliation |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA |
| Address |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAVI
Belgaum
KARNATAKA
590003
India |
| Phone |
9964144197 |
| Fax |
|
| Email |
pradeepgrampurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep L Grampurohit |
| Designation |
Reader |
| Affiliation |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA |
| Address |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAVI
Bagalkot
KARNATAKA
590003
India |
| Phone |
9964144197 |
| Fax |
|
| Email |
pradeepgrampurohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAVI |
|
|
Primary Sponsor
|
| Name |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA |
| Address |
KAHERs SHRI B M K AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAVI |
| 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 |
| upasna |
Opd No 04 and IPD of KLE Ayurveda Hopital |
Near Nathpai Circle shahapur belgaum
Belgaum
KARNATAKA |
7018767899
upasna19july4019@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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Udvartana with kulatha churna expernally for 7 days and
Nitya Virechana with trivrith lehyam 15gm internally for 7 days |
Udvartana with kulatha churna expernally for 7 days and
Nitya Virechana with trivrith lehyam 15gm internally for 7 days
followed by Lifestyle Modification(20Days)
Total 30 Days
|
| Comparator Agent |
udwartana |
udwartana with kulatha churna externally for (7days) followed by vishram kala(3days) followed by lifestyle modification(20days)
total 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with BMI > 25 to 40 will be selected irrespective of age sex and religion
|
|
| ExclusionCriteria |
| Details |
History of any systemic illness
Obesity caused by Hormonal imbalance
Patients showing signs and symptoms of arthritis
Acute joint trauma
Complete loss of Articular cartilage
Any kind of skin disease
Pregnant and lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The combined effect of Udvartana, Nitya Virechana with Lifestyle Modification is more effective than the Udvartana and Lifestyle Modification in Obesity |
Two Times Before and After
0th day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2019 |
| 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="6"
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
|
Worldwide obesity has nearly trippled since 1975. More than 1 in 2 adults and 1 in 6 children are overweight or obese in organisation for Economic Co- operation and Development Countries. OECD predicts that levels of overweight and obesity will continue to rise further by 2030 .Nitya virechana suggests the evacuation of vrudha doshas on daily basis. udwartana , yoga and diet therapy are the key factors in handeling obesity. Udwartana tones the skin , remove toxins and is very effective in reducing cellulite and fat accumulation.rubbing herbal powder helps breaking down the cellulite and increase the burning of accumulated fat. lifestyle modification plays an importand role in obesity. it is noted that the increased physical activity for 300min/week is associated with significant weight reduction. Diet plays an important role in weight reduction by an average of 5.4kg in 12months. |