| CTRI Number |
CTRI/2019/03/018234 [Registered on: 22/03/2019] Trial Registered Prospectively |
| Last Modified On: |
11/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rule out the Effect of Exercise, Lukewarm Water and both in Overweight Individuals.
|
|
Scientific Title of Study
|
An uncontrolled open parallel study of ushnodakapan, vyayam and both in medovriddhi w.s.r to B.M.I. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika mehra |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA.PARUL UNIVERSITY |
| Address |
department of kriya sharira parul institute of ayurveda limda waghodia vadodara gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9340508387 |
| Fax |
|
| Email |
dpka2210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaidehi V Raole |
| Designation |
professor |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA.PARUL UNIVERSITY |
| Address |
department of kriya sharira parul institute of ayurveda limda waghodia vadodara gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
|
| Email |
vraole3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaidehi V Raole |
| Designation |
professor |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA.PARUL UNIVERSITY |
| Address |
department of kriya sharira parul institute of ayurveda limda waghodia vadodara gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
|
| Email |
vraole3@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of ayurved parul university waghodia vadodara gujarat |
|
|
Primary Sponsor
|
| Name |
Department Of kriya sharir |
| Address |
Parul Institute Of Ayurved Parul University, Limda, Vadodara,
Gujarat-391760
|
| 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 |
| deepika mehra |
parul institute of ayurveda |
department of kriya sharir parul istitute of ayurveda limda waghodia vadodara GUJARAT pi code -391760
Vadodara
GUJARAT |
9340508387
dpka2210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ushnodakpana (Luke warm water) -group A |
dose-100 ml
frequency-once a day(od) after meal at night.
administration- orally
duration of treatment- 30 days
|
| Intervention |
ushnodakpana (luke warm water) and vyayama (exercise) -group c |
dose-100 ml (luke warm water) and ardha shakti vyayama exercise(half of body stamina)
frequency-luke warm water once a day (Od) at night after meal and vyayama - once a day(od) at morning before meal
administration- orally for luke warm.
vyayama- nil
duration of therapy-30 days for both.
|
| Intervention |
vyayama (exercise)- group B |
dose- ardha shakti (half of body stamina)
frequency- once a day at morning before meal
administration- nil
duration of therapy-30 days.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.B.M.I criteria will be assessed i.e >25 and <30 for selection of subject.
2.medovriddhi will be assessed with ayurvedic criteria. |
|
| ExclusionCriteria |
| Details |
1. Person have any type of systemic or other illness or on any type of medication.
2. The subjects having B.M.I. <25 and >30 will be excluded.
3. Cold water will be advised for avoiding for drinking.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Luke warm water and exercise has beneficial effect in overweight
Measuring parameter-
Body Mass Index ( B. M. I )
Time duration-
30 days |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ushnodakpana (luke warm water) has beneficial effect on medo vriddhi (overweight)
parameter -Body Mass Index(B.M.I)
|
30 days. |
vyayama (Exercise) has beneficial effect on medo vriddhi (over weight)
Measuring parameter- Body Mass Index (B.M.I) |
30 days. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2019 |
| 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
Modification(s)
|
Years="1"
Months="6"
Days="30" |
|
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
|
BRIEF SUMMARY O PURPOSE- •Medovriddhi is caused due to vitiation of Medodhatu and Meda Dhatvagnimandya and if it is not managed it leads further diseased condition like Sthoulya, Prameha etc.•
That’s why this has drawn my attention towards prevention of diseases & control of Medovriddhi with the help of ayurvedic management in the form of Ushnudakapan and Vyayama.
BACKGROUND OF TRIAL-
ü It is the comparative study in which 90 subjects will be selected on the basis of inclusion and exclusion criteria . Group of 30 will be randomly made.
üMedovriddhi will be assessed with the ayurvedic criteria (Subjectively) and observation by BMI (Objectively) modern criteria.
It will be divided in to three group having 30 subject each. 1. First group(A), will be given Ushnaudakpan (30 subjects).
2. In second group(B), Vyayama will be advised (30 subjects). 3. In third group(C), will be given both Ushnaudakpan and Vyayama (30 subjects). With out disturbing there daily routine life style, and analysis of study will be done after statistical collection on the basis of observed data. Follow up will be taken in 1,15 and 30days.
FINDINGS- THERE WILL BE A SIGNIFICANT EFFECT OF VYAYAMA( EXERCISE ) AND USHNAUDAKPA (LUKE WARM WATER) IN MEDOVRIDDHI (OVER WEIGHT) |