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CTRI Number  CTRI/2024/06/068985 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [Diet]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on the effect of Plant based Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune 
Scientific Title of Study   Effect of Plant Dominant Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune , India - A Randomized Prospective Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anindita Ghosh 
Designation  PhD Scholar 
Affiliation  Symbiosis International University 
Address  Room No. 4, Department of Nutrition and Dietetics, Symbiosis School of Culinary Arts, Symbiosis International University, Lavale, Village, Taluka, Mulshi, Pune

Pune
MAHARASHTRA
412115
India 
Phone  9874122419  
Fax    
Email  aninditaghosh29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arti Muley 
Designation  Assistant professor  
Affiliation  Symbiosis International University 
Address  Room No. 4, Department of Nutrition and Dietetics, Symbiosis School of Culinary Arts, Symbiosis International University, Lavale, Village, Taluka, Mulshi, Pune

Pune
MAHARASHTRA
412115
India 
Phone  9874122419  
Fax    
Email  asstprofnd@ssca.edu.in  
 
Details of Contact Person
Public Query
 
Name  Anindita Ghosh 
Designation  PhD Scholar 
Affiliation  Symbiosis International University 
Address  Room No. 4, Department of Nutrition and Dietetics, Symbiosis School of Culinary Arts, Symbiosis International University, Lavale, Village, Taluka, Mulshi, Pune

Pune
MAHARASHTRA
412112
India 
Phone  9874122419  
Fax    
Email  aninditaghosh29@gmail.com  
 
Source of Monetary or Material Support  
Symbiosis University Hospital & Research Centre Dnyan Marg, Mulshi Rd, Lavale, Maharashtra 412115 
 
Primary Sponsor  
Name  Anindita Ghosh 
Address  Symbiosis International (Deemed University) Gram: Lavale, Tal: Mulshi, Dist: Pune, Maharashtra, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
DrArti Muley  Symbiosis International (Deemed University), Lavale, Maharashtra 412115 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrGirish Kumthekar  Symbiosis University Hospital & Research Centre  Room No.104, Nephrology Unit, Department of Nephrology and Dialysis Division, Lavale, Mulli, Pune
Pune
MAHARASHTRA 
7032295272

girish.kumthekar@suhrc.siu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Symbiosis International (Deemed university)Institutional Ethics Committee (BHR)-II,SIU-Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Plant Dominant Low Protein Diet   More than 50% plant-dominant, low-protein diet, oral for 3 months  
Comparator Agent  Renal diet   Standard renal diet , oral for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Location: Pune district Maharashtra India
Food habits: Both vegetarian and non-vegetarian food habits.
Nutritional status :well-nourished to moderately malnourished (as per the SGA tool and nutrition focused physical exam)
Activity: light to medium physical activity
Willing to participate or consenting to the study

 
 
ExclusionCriteria 
Details  Not diagnosed with CKD
Patient of CKD stage 4-5 (ESRD) with GFR (less than 30 mL/min/1.73 m²)
pediatric and geriatric population
Outside Pune district Maharashtra India,An acute or chronic communicable infection, pregnancy, lactation or any critical illness, heart disease, liver disease, cancer, Malabsorptive diseases like short bowel syndrome or Irritable bowel disease, continuous supportive dialysis care for management of the disease.
Severely malnourished nutritional status
Bed ridden; physically-mentally handicapped, dependent individuals
Unwilling to participate/not giving consent to the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the nutritional status and dietary intake, frequency of the symptoms (Vomiting, diarrhea, nausea, anorexia, loss of appetite. Regulation of the renal biochemical parameters (Hemoglobin,E-GFR , Urine-albumin creatinine ratio, Uric acid, electrolytes,HbA1C,Blood pressure monitoring).Compliance and adherence rate to diet.  4 months  
 
Secondary Outcome  
Outcome  TimePoints 
1.Monitor the improvement in nutritional status,dietray intake after the initiation of plant dominant low protein diet
 
4 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 2 
Date of First Enrollment (India)   01/07/2024 
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="0"
Months="8"
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 study titled "Effect of Plant Dominant Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune, India - A Randomized Prospective Controlled Study" aims to investigate the impact of a plant-based low protein diet on patients with chronic kidney disease (CKD). Chronic kidney disease is a progressive condition characterized by gradual loss of kidney function, and dietary management plays a crucial role in slowing disease progression and managing symptoms.

Summary: The trial involves chronic kidney disease patients from selected hospitals in Pune, India, who are randomized into two groups: one receiving a plant-dominant low protein diet and the other continuing with a standard diet. The study is prospective and controlled, meaning that patients are followed over time and their outcomes are compared between the two groups. Key measures include kidney function parameters, nutritional status, and dietray compliance and adherence.

Purpose: The primary purpose of the study is to determine whether a plant-dominant low protein diet can significantly improve kidney function and overall health outcomes in CKD patients compared to a standard diet. This includes evaluating the effects on biochemical markers of kidney function, nutritional deficiencies,dietray intake, adherence and compliance to the diet . The study aims to provide evidence on the benefits and feasibility of implementing a plant-based dietary approach in the management of CKD, potentially offering a sustainable and beneficial dietary strategy for these patients.


 
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