| CTRI Number |
CTRI/2013/05/003689 [Registered on: 28/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
01/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of different diet preparation on weight gain |
|
Scientific Title of Study
|
Comparative clinical study of Yavagoo and Odana Kalpana of Kodrava(Paspalum Scrobiculatum)on Sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKhushbu Gupta |
| Designation |
Ph.D. Scholar |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
Dept of Basic principles
IPGT RA
jamnagar
Dept of Basic principles
IPGT RA
jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09586283184 |
| Fax |
|
| Email |
khushirg11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh Vyas |
| Designation |
Assistant professor |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
Dept of Basic principles
IPGT RA
jamnagar
Dept of Basic principles
IPGT RA
jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9426433231 |
| Fax |
|
| Email |
drhavyas@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitesh Vyas |
| Designation |
Assistant professor |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
Dept of Basic principles
IPGT RA
jamnagar
Dept of Basic principles
IPGT RA
jamnagar
GUJARAT
361008
India |
| Phone |
9426433231 |
| Fax |
|
| Email |
drhavyas@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| IPGT RA
Gujarat Ayurved University
jamnagar |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
IPGT RA Gujarat Ayurved University jamnagar |
| 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 khushbu Gupta |
Department of Basic Principles |
IPGT RA Gujarat Ayurved University jamnagar
Jamnagar
GUJARAT |
09586283184
khushirg11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 Vide Ref- PGT/7-A/Ethi cs/2012-2013/3552 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kodrava ( Paspalum Scrobiculatum) |
Its a food article. In this study it is given once in a day as a main meal of the day for 30 days Two differ mode of preparation is used as comparison of their effect |
| Intervention |
Kodrava Yavagoo |
Its a food article. In this study it is given once in a day as a main meal of the day for 30 days Two differ mode of preparation is used as comparison of their effect |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 20 years to 60 years and having classical signs and symptoms of Sthaulya i.e. Chala Sphik Udara Stana, Kruchravyavaya, Angagandha, Swedadhikya, Kshudhadhikya, Pipasadhikya, Kshudra Shwasa, Nidradhikya |
|
| ExclusionCriteria |
| Details |
1. Age of patient less than 20 years and more than 60 years.
2. Patients having major illness like cardiac diseases, diabetes mellitus etc & also the involvement of other systemic disorders.
3. Patients having Sthaulya due to genetics, pregnancy, drug induced, cushing’s syndrome, hypothyroidism, other hormonal disorder and related to any disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in symptoms and weight loss after 30 days of treatment. |
May 2013 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weight loss |
June 2014
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/03/2013 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
PHARMACOGNOSTICAL AND PHYTOCHEMICAL EVALUATION OF
STHAULYAHARA DHANYA (MILLET) – KODRAVA (PASPALUM
SCROBICULATUM LINN.)
Vd. Khushbu Gupta_et al., IJSIT, 2014, 3(4),315-321 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study was
conducted to assess the effect of Kodrava (Paspalum scrobiculatum Linn.)
administered in the form of Yavagoo (Gruel) and Odana (rice) on Sthaulya. The
patients selected for the study were randomly divided into 2 groups. In group A, 58 patients were registered, out
of which 51 patients completed the therapy and 7 patients discontinued the
therapy. In group B 61 patients were registered, out of which 51 completed the
therapy and 10 patients discontinued the therapy in between.
Results: After the
treatment, in Group A maximum improvement (83.33%) was noticed in Atipiapasa (excess
thirst). More than 60% of improvement was reported in Angagaurava(Heaviness in body), Atikshudha (excess hunger), Kshudrashwasha (Dyspnoea on
exertion), Alpavyayama (weakness in exercise) and Alpavyavaya (less libido). The improvement was observed in other
symptoms also and the results were highly significant except Snigdhangata (oily
body luster) where there was significant result found.
After the treatment, in Group B maximum
improvement (100%) was noticed in Atipipasa (excess thirst), Alpavyavaya (less
libido) (83.33%), Alpavyayama (weakness in exercise) (68.23%), Kshudrashwasa (dysponea on exertion)
(62.26%) and Angashaithilya (Flabbiness in the body) (57.89%). The improvement was observed in other symptoms
also and the results were highly significant except Snigdhangata (oily body
luster) where there was insignificant result found.
Weight was reduced by 5.26% in group A and
5.22% in group B, while BMI was reduced by 4.94% and 5.18% respectively in
group A & group B. These are statistically highly significant. Group A the decrease
observed in various body circumferences were Hip (2.46%), Abdomen (1.97%), Mid
calf (2.09%). The results were significant. Group B the decrease observed in
various body circumferences were Abdomen (2.35%), Hip (1.73%), Mid thigh (1.11
%), Mid arm (1.27%). The results were statistically significant.In Group A the
reduction was observed in various skin fold thickness i.e. Biceps (0.37%),
Triceps (0.55%), Scapular (0.78%), Abdomen (1.08%), Supra iliac (0.73%). The
results were significant. In group B the reduction was observed in various skin
fold thickness i.e. Biceps (0.51%), Triceps (0.47%), Scapular (0.76%), Abdomen (0.85%),
Supra iliac (0.61%). The results were significant.
|