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CTRI Number  CTRI/2009/091/001012 [Registered on: 15/12/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Other 
Public Title of Study   Effects of the walnut consumption in the young male patients of Essential Hypertension on sleep, stress,blood pressure and various parameters of Anthropometry. 
Scientific Title of Study   Effects of the walnut consumption in the young male patients of Essential Hypertension on sleep, stress,blood pressure and various parameters of Anthropometry. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Gullapalli Hiralal Sudarshan 
Designation   
Affiliation   
Address  C/O Ambadas Bingi, 1699, Datta Nagar, Solapur
C/O Ambadas Bingi, 1699, Datta Nagar, Solapur
Solapur
MAHARASHTRA
413005
India 
Phone  0217-2745412/11  
Fax    
Email  hgullapalli2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Gullapalli Hiralal Sudarshan 
Designation   
Affiliation   
Address  C/O Ambadas Bingi, 1699, Datta Nagar, Solapur
C/O Ambadas Bingi, 1699, Datta Nagar, Solapur
Solapur
MAHARASHTRA
413005
India 
Phone  0217-2745412/11  
Fax    
Email  hgullapalli2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Gullapalli Hiralal Sudarshan 
Designation   
Affiliation   
Address  C/O Ambadas Bingi, 1699, Datta Nagar, Solapur
C/O Ambadas Bingi, 1699, Datta Nagar, Solapur
Solapur
MAHARASHTRA
413005
India 
Phone  0217-2745412/11  
Fax    
Email  hgullapalli2000@gmail.com  
 
Source of Monetary or Material Support  
NIL 
This will be completely funded by the author himself. 
 
Primary Sponsor  
Name  Dr. Gullapalli H.S., SVP II/11, Shreepuram, Kamineni Institute of Medical Sciences Campus, Narketpally-Nalgonda Andhra Pradesh India-508254 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Gullapalli H.S.  KIMS Hospital, Narketpally  SVPII/11, KIMS campus , Narketpally, Nalgonda,SVPII/11, KIMS campus , Narketpally, Nalgonda-508254
Nalgonda
ANDHRA PRADESH 		 9000748664

hgullapalli2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Kamineni Institute of Medical Sciences  Approved 
NIL   
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Stage I Essential Hypertension on the basis of the guidelines issued by the European Society of Hypertension 2007. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  -  - 
Comparator Agent  No therapy will be given  No therapy will be given 
Intervention  Walnnut  20gm for 5 weeks daily 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1] Age: 34 to 42 Years 2] Sex: Male 3] Essential Hypertension Stage I according the guidelines issued by the European Society of Hypertension 4] Body Mass index > 27 Kg/ m2  
 
ExclusionCriteria 
Details  Food allergy Allergy to the consumption of nuts Heavy Smokers Recent hypolipdaemic drug consumption 1]Abnormal obesity 2]Familial history of lipid disorders 3]Complicated Hypertension with end organ damage like Left 4]ventricular hypertrophy, chronic renal failure, stroke, cerebrovascular accidents etc.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A] Stress: By using perceived stress scale B] Sleep: By using Epworth Sleepiness Scale(and Petersburg Sleep Quality Index. C] Blood Pressure: . C] Blood Pressure: Systolic Blood pressure Diastolic Blood Pressure D] Anthropometry: Parameters- 1] Body Mass Index 2] Waist Circumference 3] Hip circumference 4] Waist-to-hip ratio   In 5 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="0"
Sample Size from India="" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/11/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years=""
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a follow-up intervention study. In which the base line values are recorded and the dietary intervention done using 20 grams of walnut everyday in their die for 5 weeks . They are not instructed for any diet change except the inclusion of walnut in the daily diet. They are asked to consume walnut in the two divided doses in the form of snacks or salads 10 gram in each session before or after meals. The patients are asked to go through the questionnaire like Epworth Sleepiness scale questionnaire, Petersburg Sleep Quality Index questionnaire for sleep quality and Perceived stress scale questionnaire for stress and answer them. With the help of the methodology available in these format the scoring is done for sleep and stress before start of the study and at the end of the study. The baseline readings for the the blood pressure is recorded in accordance with the European Society of Hypertension guideline, 2007 for blood pressure measurement in the sitting position with the help of Mercury Sphygmomanometer before the start and end of the study. Various anthropometric measurements are done like height, weight, waist, hip circumference. The body mass index and Waist-to-hip ratio is calculated with the help of the standard available formula. These measurements are taken at the start and on the end of the study period.  
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