FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069562 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Effect of pumpkin seed on blood sugar, fat and hereditary status of Metabolic Syndrome 
Scientific Title of Study   Effect of pumpkin seed on anthropometric, biochemical and genetic marker of Metabolic Syndrome 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dileep Kumar Verma 
Designation  Professor 
Affiliation  King Georges Medical University  
Address  Department of Physiology, King Georges Medical University Shah Mina Road, Chowk

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415469113  
Fax    
Email  dileepvermaindia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dileep Kumar Verma 
Designation  Professor 
Affiliation  King Georges Medical University 
Address  Department of Physiology, King Georges Medical University Shah Mina Road, Chowk

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415469113  
Fax    
Email  dileepvermaindia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dileep Kumar Verma 
Designation  Professor 
Affiliation  King Georges Medical University 
Address  Department of Physiology, King Georges Medical University, Shah Mina Road, Chowk

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415469113  
Fax    
Email  dileepvermaindia@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiology, King Georges Medical University, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003  
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 
Dr Dileep Kumar Verma  King Georges Medical University  Department of Physiology, King Georges Medical University, Shah Mina Road, Chowk
Lucknow
UTTAR PRADESH 
9415469113

dileepvermaindia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, King Gorges Medical University, Lucknow, UP, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pumpkin seed powder  30 gm/day (15 gm before half an hour of breakfast and 15 gm before half an hour of dinner) from baseline till 3 months 
Comparator Agent  Control(No intervention)  Without pumpkin seed supplementation from baseline till 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Metabolic syndrome patients aged between 18-60 years
2. Metabolic Syndrome with three or more of the following five criteria is met:
hyperglycemia, raised blood pressure, elevated triglyceride levels, low high-density
lipoprotein cholesterol levels, and central obesity [NCEP (ATP III)].
3. Patient of either sex i.e., both male and female.
4. Patient willing to consent in writing 
 
ExclusionCriteria 
Details  1. Patient not willing to participate in the study
2. Aged less than 18 and more than 60years
3. Pregnant, nursing, or planning for pregnancy
4. Active medical condition- a known allergy or intolerance
5. Patient having any medical or surgical illness requiring priority management
6. Patient with other endocrinal diseases
7. Patient with Frank hepatorenal complication
8. Patient with chronic illness, congenital disorder, neurological and psychiatric disorder.
 
 
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 
1.Manage reduction of Fasting blood glucose and Post prandial glucose
2. Decrease HbA1c
 
Glycaemic profile will be measured:
First is at Baseline (at the time of patient
enrollment)
Second is Follow-up (after 12 weeks {3
months} of patient enrollment)

 
 
Secondary Outcome  
Outcome  TimePoints 
3. Decrease Triglycerides, low-density
lipoproteins Cholesterol, Total
Cholesterol, Increase HDL
4. Decrease IL-6 (Interleukin-6), TNFα
5. Expression enhancement of Adiponectin levels & its gene expression due to alternative
therapies (pumpkin seed powder) 
Anthropometric Measurements, Clinical
parameters, Biochemical Parameters, genetic marker will be
measured:
First is at Baseline (at the time of patient
enrollment)
Second is Follow-up (after 12 weeks {3
months} of patient enrollment)
 
 
Target Sample Size   Total Sample Size="648"
Sample Size from India="648" 
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)   15/07/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The metabolic syndrome is a cluster of risk factors that identifies a population with increased risk for developing type T2DM and cardiovascular disease (CVD). The prevalence of metabolic syndrome in urban population of India was 32%. The Adult Treatment Panel III (ATPIII) criteria of the National Cholesterol and Education Program (NCEP The diagnostic criteria for metabolic syndrome are the presence of any three of the following five components is diagnostic for the metabolic syndrome: Central obesity, elevated blood pressure, raised fasting glucose, raised levels of triglycerides and low levels of high-density lipoprotein cholesterol. Although, the most common treatment is medications but in recent time, use of nutritional methods and medicinal plants are also increasing and gaining importance due to their high margin of safety. However, some of them have been studied scientifically and pumpkin seed is one of them. Thus, the objective of the study was to assess the effect of pumpkin seeds on glycaemic profile, lipid profile, anthropometric measurements and adiponectin level and its gene expression in metabolic syndrome patients. The study patients will be recruited from OPD of Department of Medicine, with collaboration Department of Physiology, King Georges Medical University, Lucknow. Enrollment of patients will be done according to inclusion criteria. Then baseline assessments will be done of anthropometric measurements i.e., BMI, WHR, biochemical parameters like CBC, FBS, PPBS, HbA1c and TG, TC, LDL, HDL, IL-6 (Interleukin-6), Tumor necrosis factor- alpha (TNF-α), Adiponectin level and its Gene Expression and clinical parameters including BP and Heart rate. Then supplementation of 30 gm pumpkin seed per day i.e., 15 gm before half an hour of breakfast and 15 gm before half an hour of dinner will be given to the case group patients for 3 months and no intervention in the control group will be given. Compliance of daily consumption of pumpkin seeds would be monitored in the case group. All case group patients will be requested to return their supplement packaging every month. The pumpkin seeds will be provided to the patients every month for a duration of 3 months. The follow up assessment of the patients will be done after 3 months of pumpkin seed supplementation. The baseline and follow up assessments, data will be compiled, entered in Microsoft Excel spreadsheet for further data statistical analysis.

 
Close