| CTRI Number |
CTRI/2013/03/003484 [Registered on: 15/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
14/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
This is A COMPARATIVE CLINICAL STUDY to see THE EFFECT OF GUDUCHI-BHADRAMUSTADI YOGA ADMINISTERED ORALLY AND AS BASTI(enema), IN THE MANAGEMENT OF OBESITY, for reducing weight |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFECT OF GUDUCHI-BHADRAMUSTADI YOGA ADMINISTERED ORALLY AND AS BASTI IN THE MANAGEMENT OF STHAULYA W.S.R. 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 |
Vd Hemal Dodiya |
| Designation |
PG Scholar |
| Affiliation |
Institute for postgraduate teaching and research in ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Department of Panchakarma Institute for
postgraduate teaching and research in ayurveda Gujarat Ayurved
University Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9898259727 |
| Fax |
|
| Email |
hem_ayu17@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup B Thakar |
| Designation |
Reader |
| Affiliation |
Institute for postgraduate teaching and research in ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Department of Panchakarma Institute for
postgraduate teaching and research in ayurveda Gujarat Ayurved
University Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup B Thakar |
| Designation |
Reader |
| Affiliation |
Institute for postgraduate teaching and research in ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Department of Panchakarma Institute for
postgraduate teaching and research in ayurveda Gujarat Ayurved
University Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of postgraduate teaching and research in ayurved Gujarat Ayurved University Jamnagar
361008 |
|
|
Primary Sponsor
|
| Name |
Istutitute of Postgraduate Teaching and Research in Ayurveda |
| Address |
Gujarat Ayurveda University Jamnagar 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 |
| Dr Hemal Dodiya |
Institute of postgraduate teaching and research in ayurveda |
OPD no 20 Dept of
Panchakarma Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9898259727
hem_ayu17@yahoo.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 |
obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi-Bhadramustadi Yoga basti
|
Guduchi Bhadramustadi Yoga basti was given for 16 days Basti in scheduleof 1 anuvasan 3 niruha 1 anuvasan 3 niruha 1 anuvasan 3 niruha 1 anuvasan 2 niruha 1 anuvasan total 16 Basti with follow up of 1 month
|
| Comparator Agent |
Guduchi-Bhadramustadi Yoga Ghanavati |
Guduchi Bhadramustadi Yoga Ghanavati was given 7gm per day into 3 divided doses before meal with luke warm water for 1 month and 15 days of follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical sign and symptoms of Sthaulya like Chala Udara Stana Sphika Javoparadha Kruchravyavaya Durbalata Atikshudha Atitrishna etc
Patient having sign and symptoms of Obesity like Large body frame Having extra fat around the waist Difficulty in doing daily activities Lethargy Breathlessness Increased weight Snoring Heavy sweating Difficulty while sleeping Etc
BMI more than 25 and less than 40
BMI Prime more than 1
Waist hip ratio Male: more than 0.95
Female more than 0.80
|
|
| ExclusionCriteria |
| Details |
Patients having age less than 18 years & above 60 years.
Patients having serious cardiac, renal and hepatic diseases etc.
Patients having major illness like Diabetes Mellitus which is poorly controlled.
Patients having history of untreated thyroid disorders and uncontrolled Hypertension and other endocrine diseases.
Obesity due to drugs e.g. Anticonvulsant, antipsychotics, Beta-blockers, Corticosteroid.
Pregnant females & lactating women.
BMI>40 will be excluded.
Waist-Hip ratio: Man: 0.95 or below
Female: 0.80 or below
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weight reduces
In basti group more than ghanavati group |
1.5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In basti group weight reduces more than ghanavati group |
45 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a random open trial which is
divided into two groups.
In one group, Guduchi-Bhadramustadi Yoga
basti was given for 16 days (Basti in scheduleof 1 anuvasan 3 niruha
1 anuvasan
3 niruha
1 anuvasan
3 niruha
1 anuvasan
2 niruha
1 anuvasan
=16 Basti) with follow up of 1 month.
In second group, Guduchi-Bhadramustadi Yoga
Ghanavati was given 7gm/day into 3 divided doses before meal with luke warm
water for 1 month & 15 days of follow up.
Effect of therapy will be
assessed by before and after values of routine
hematological, urine investigation, lipid profile, weight, body girth
measurement.
|