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CTRI Number  CTRI/2017/09/009891 [Registered on: 22/09/2017] Trial Registered Retrospectively
Last Modified On: 18/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Action of Warm Water on over Weight and BMI. 
Scientific Title of Study   To study the effect of Usnodaka over medodhatu w.s.r to bmi and body weight 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay kumar tripathi 
Designation  Pg scholar 
Affiliation  Parul institute of ayurveda 
Address  Room no-105 Parul institute of ayurveda Parul university, P.O liomda, Tal.waghodia-391760 Dist- Vadodara, Gujara(india)

Vadodara
GUJARAT
391760
India 
Phone  8004697960  
Fax  02668260201  
Email  akt3j06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumant Aparna karnad 
Designation  professor 
Affiliation  Parul institute of ayurveda 
Address  Room no-105 Parul institute of ayurveda Parul university, P.O liomda, Tal.waghodia-391760 Dist- Vadodara, Gujara(india)

Vadodara
GUJARAT
391760
India 
Phone  9822595463  
Fax  02668260201  
Email  sumant.karnad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay kumar tripathi 
Designation  Pg scholar 
Affiliation  Parul institute of ayurveda 
Address  Room no-105 Parul institute of ayurveda Parul university, P.O liomda, Tal.waghodia-391760 Dist- Vadodara, Gujara(india)
Room no-105 Parul institute of ayurveda Parul university, P.O liomda, Tal.waghodia-391760
Vadodara
GUJARAT
391760
India 
Phone  8004697960  
Fax  02668260201  
Email  akt3j06@gmail.com  
 
Source of Monetary or Material Support  
Room no-105 Parul institute of ayurveda Parul university, P.O liomda, Tal.waghodia-391760 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ajay Kumar Tripathi  Parul insititue of Ayurveda  ROOM NO.115,Parul ayurved hospital,P.O.LIMDA,Tal.Waghodia,391760
Vadodara
GUJARAT 		 8004697960
02668260201
akt3j06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
human institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Obesity(initial stage),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Ushnajala  Ushnajala one glass 3 times a day before intake of food for 3 month.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. The volunteers whose age group > 20 and < 50 yeara will be selected.

2.B.M.I Ranges from - 30.0 kg/m2 ->-40 kg/m2






 
 
ExclusionCriteria 
Details  1. The volunteers below the age of 20 years and above 50 years.
2. The volunteers suffering from any systemic illness
3. The volunteers having B.M.I. >30.0 kg/m2will be excluded
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Warm water is effects on reduce on the body weight.  3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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   N/A 
Date of First Enrollment (India)   21/07/2017 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

HYPOTHESIS

Null Hypothesis (H0):  There is no effect of Usnodaka in Sthoulytha over  Medadhatu .

Alternate Hypothesis (H1): There is an effect of Usnodaka in Sthoulytha over  Medadhatu .

AIMS AND OBJECTS

1.      To study the effect of usnodaka on agni

2.      To study the effect of agni on medodhatu

3.      To study effect of usnodhaka on sthoulytha.

4.      To see the relation between medodhatu, sthoulytha  w.s.r to BMI and body Weight.

INCLUSION CRITERIA

1.      The volunteers whose age group >20 and <50 years will be selected.

2.      B.M.I Ranges from - 30.0 kg/m2 ->-40 kg/m2 [i]

EXCLUSION CRITERIA

1. The volunteers below the age of 20 years and above 50 years.

2. The volunteers suffering from any systemic illness

3. The volunteers having B.M.I. >30.0 kg/m2will be excluded.

Criteria of assessment:                            

1.      Agni parikshan will be done on agni parikshan format.

2.      B.M.I: A frequent use of the BMI is to assess how much an individual’s body weight departs from what is normal or desirable for a person’s height.The weight excessor deficiency may,in part,be accounted for by body fat (adipose) although otherfactors such as uscularity also affect BMI of less than 18.5 as underweight and may indicate malnutrition,an eating disorder,or other health problem,while a BMI equal to or greater than 25 is considered overweight and above 30 is considered obese.

These ranges of BMI values are valid only as statistical categories.

BMI= Weight in kilograms / (Height in Meters × Height in Meters)

Underweight                - < 18.5 kg/m2

Normal weight              -  18.5-24.9 kg/m2

Over weight                  -> 25.00 kg/m2

Pre obese                        - 25.0-29.9 kg/m2

Obesity class 1                - 30.0-34.9 kg/m2

Obesity class 2                 -35.0-39.9 kg/m2

Obesity class 3                 ->-40 kg/m2 [i]


 

 



 
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