| CTRI Number |
CTRI/2024/08/071964 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Effect OF Powder massage with two different Drugs for weight loss in Obesity. |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparitive Clinical Study To Evaluate the Efficacy of Udwartana with Kolakulattadi Choorna with Triphala Choorna and Lekhaneeya gana choorna Followed by Shamanaushadhi in Sthoulya vis-A-vis Obesity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bagali Kavya |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital. |
| Address |
Room no 02,Department of Panchakarma,JSS Ayurveda Medical College and Hospital,#41/E, Lalithadripura,Mysuru-570028
Room no 02,Department of Panchakarma,JSS Ayurveda Medical College and Hospital,#41/E, Lalithadripura,Mysuru-570028
Mysore
KARNATAKA
570028
India |
| Phone |
7899204530 |
| Fax |
08212548360 |
| Email |
kavyab882@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena G Rao |
| Designation |
Head and Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
ROOM NO 02,DEPARTMENT OF PANCHAKARMA,JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL,#41/E, LALITHADRIPURA,MYSURU-570028
ROOM NO 02,DEPARTMENT OF PANCHAKARMA,JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL,#41/E, LALITHADRIPURA,MYSURU-570028
Mysore
KARNATAKA
570028
India |
| Phone |
9844549152 |
| Fax |
08212548360 |
| Email |
drveenagrao@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena G Rao |
| Designation |
Head and Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital. |
| Address |
Room NO 02,Department of Panchakarma,JSS Ayurveda Medical College and Hospital,#41/E, Lalithadripura,Mysuru-570028
Room NO 02,Department of Panchakarma,JSS Ayurveda Medical College and Hospital,#41/E, Lalithadripura,Mysuru-570028
Mysore
KARNATAKA
570028
India |
| Phone |
9844549152 |
| Fax |
08212548360 |
| Email |
drveenagrao@yahoo.in |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital, 41/E, Lalithadripura Road, Mysuru, KARNATAKA, 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Bagali Kavya |
| Address |
Department of PG Studies in Panchakarma ,JSS Ayurveda Medical College,41/E ,Lalithadripura Road,MYSURU-570028 |
| Type of Sponsor |
Private 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 BAGALI KAVYA |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
Room No 2,Department of Panchakarma OPD,41/E,LALITHADRIPURAM ROAD,MYSURU,KARNATAKA,570028
Mysore
KARNATAKA |
7899204530
kavyab882@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH, (2) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: Charaka samhita, Procedure details: According to SOP of hospital)
(1) Medicine Name: Lekhaneeya gana choorna, Reference: Charaka samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 400(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: charaka samhita, Procedure details: According to SOP of hospital.)
(1) Medicine Name: Kolakulattadi choorna with triphala choorna, Reference: sharangadhara samhita,charaka samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 400(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients diagnosed with Sthoulya, who fulfill the diagnostic criteria.
-Patients within the age group of 18 – 60 years.
-Patients of all gender.
-Patients who are fit for Udwartana.
|
|
| ExclusionCriteria |
| Details |
-Patients with Atisthoulya -BMI more than 40.
-Patients of Sthoulya with other complications like coronary heart disease, cerebro vascular disease or with any other systemic disorders which interfere with the course of the treatment will be excluded.
-Pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN THE WEIGHT |
8th day & 23rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN BMI |
8TH day & 23rd day |
|
|
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)
|
16/08/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Obesity is an unhealthy accumulation of body fat. The prevalence of obesity is increasing rapidly in most of the industrialized world. Obesity is associated with an increase risk of multiple health problems, including Hypertension, Type-2 Diabetes Mellitus, Dyslipidemia, Degenerative Joint Diseases, and some Malignancies. Thus, it is important for physicians to treat patients of obesity and associated comorbidities .This study is a novel as Charakokta Lekhaneeya Gana drugs are not used regularly in practice for Udwartana and Kashaya Pana for treatment of Sthoulya. In this study 40 subjects diagnosed with sthoulya, irrespective of gender will be randomly allocated into 2 groups. group A-20 subjects and Group B-20 subjects. |