| CTRI Number |
CTRI/2016/02/006683 [Registered on: 26/02/2016] Trial Registered Prospectively |
| Last Modified On: |
25/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment of Sthaulya in Ayurveda |
|
Scientific Title of Study
|
A comparative study of Virechana karma and Vidangadi yoga in the management of sthaulya wsr to obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetna Mehta |
| Designation |
MD Scholar |
| Affiliation |
IPGT RA Jamnagar Gujarat |
| Address |
Department of Panchakarma IPGT RA Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9824501187 |
| Fax |
|
| Email |
jolly11367@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof A B Thakar |
| Designation |
HOD Department of Panchakarma |
| Affiliation |
IPGT RA Jamnagar Gujarat |
| Address |
4th Floor IPGT RA Gujarat Ayurved University Jamnagar
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof A B Thakar |
| Designation |
HOD Department of Panchakarma |
| Affiliation |
IPGT RA Jamnagar Gujarat |
| Address |
4th Floor IPGT RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| IPGT RA GAU Jamnagar Gujarat India |
|
|
Primary Sponsor
|
| Name |
IPGT RA GAU Jamnagar India |
| Address |
IPGT RA GAU Jamnagar India 361008 |
| 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 |
| Chetna Mehta |
Department of Panchakarma IPGT and RA |
IPGT and RA Gujarat
Ayurved University
Jamnagar
Jamnagar
GUJARAT |
9824501187
jolly11367@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
obesity , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Capsule |
Plecebo Capsule of Roasted wheat flour of 500mg 2 tab thrice a day |
| Comparator Agent |
Vidangadi yoga as Shamana drug |
Vidangadi yoga 4 tab each 500mg thrice per day for 1 month |
| Intervention |
Virechana karma followed by Vidangadi yoga as Shamana drug |
Virechana karma with Trivritta avleha Triphala Churna Eranda taila as per Kostha along with Vidangadi yoga 4 tab each 500mg thrice per day for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical sign and symptoms of Sthaulya like chala udara stana sphika javoparodha kruchavyavaya durbalata atikshudha atitrishna etc
Patients having sign and symptoms of obesity like large body frame having extra fat around the waist difficulty in doing daily activites lethargy breathlessness increase weight snoring heavy sweating difficulty while sleeping |
|
| ExclusionCriteria |
| Details |
Patients having age less than 18 and more than 60
strong family history of obesity
obesity associated with DM HTN Hyperlipidemia Hypothyroidism and cushing syndrome
Patients having serious disorder of liver kideny heart lungs or other orgen
obesity due to drugs
pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of
relief found in cardinal symptoms of
disease
Progress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment |
Improvement will be assessed on the basis of
relief found in cardinal symptoms of
disease
Progress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of
relief found in cardinal symptoms of
disease
Progress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment |
less than 1 month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/03/2016 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current study is planned to validate the efficacy of Virechana karma and shamana yoga in the management of Sthaulya.
In group A Classical Virechana karma followed by Shamana drug with Pathyapathya
In Group B Vidangadi yoga as Shamana yoga,4 tab of 500 mg thrice a day will be given for 1 month with Pathyapathya as mention in Sthaulya
In Group c Placebo controlled group. |