FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/01/039474 [Registered on: 17/01/2022] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Dietary factors that affect kidney function 
Scientific Title of Study   Association between Rakta - Meda vitiating diet and Chronic kidney disease - A case control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali saini 
Designation  MD Ayurveda Scholar of Roga Nidana evam Vikriti Vigyana 
Affiliation  Institute of Teaching and Research in Ayurveda, Ministry of Ayush, Jamnagar 
Address  Room no 515, Department of Roga Nidana evam Vikriti Vigyana, Institute of Teaching and Research in Ayurveda, Ministry of Ayush, Jamnagar, Gujarat, India

Jamnagar
GUJARAT
361008
India 
Phone  9999026071  
Fax    
Email  anjalisaini9691@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Darshna Pandya 
Designation  Assistant Professor of Roga Nidana evam Vikriti Vigyana 
Affiliation  Institute of Teaching and Research in Ayurveda, Ministry of Ayush, Jamnagar 
Address  Room no 515, Department of Roga Nidana evam Vikriti Vigyana, Institute of Teaching and Research in Ayurveda, Ministry of Ayush, Jamnagar, Gujarat, India

Jamnagar
GUJARAT
361008
India 
Phone  9099011095  
Fax  02882676856  
Email  darshnapandya73@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Darshna Pandya 
Designation  Assistant Professor of Roga Nidana evam Vikriti Vigyana 
Affiliation  Institute of Teaching and Research in Ayurveda, Ministry of Ayush, Jamnagar 
Address  Room no 515, Department of Roga Nidana evam Vikriti Vigyana, Institute of Teaching and Research in Ayurveda, Ministry of Ayush, Jamnagar, Gujarat, India

Jamnagar
GUJARAT
361008
India 
Phone  9099011095  
Fax  02882676856  
Email  darshnapandya73@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Ministry of Ayush, Opposite Reliance Smart, near B Division police station, Jamnagar, Gujarat 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Ministry of Ayush 
Address  Gujarat Ayurved University, Opposite Reliance Smart, near B Division police station, Jamnagar, Gujarat 361008 
Type of Sponsor  Research institution and hospital 
 
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 
Anjali saini  Institute of Teaching and Research in Ayurveda  OPD no. 16, Department of Roga Nidana evam Vikriti Vigyana, Institute of Teaching and Research in Ayurveda, Gujarat Ayurved University, Opposite Reliance Smart, near B Division police station, Jamnagar, Gujarat 361008
Jamnagar
GUJARAT 
9999026071

anjalisaini9691@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age and gender matched healthy individuals will be selected as control. Their health status will be ascertained by sign and symptoms of healthy person mentioned in Khila sthana of Kashyapa Samhita 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Diagnosed patients of CKD with chronicity less than or equal to 1 yr, Patients of age more than or equal to 20 yrs, Patients willing to participate and follow study protocol
 
 
ExclusionCriteria 
Details  Patients of age less than 20 yrs, Patients not willing to abide by study protocol
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between Rakta - Meda vitiating diet/activities and CKD  one day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "124"
Final Enrollment numbers achieved (India)="124" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/04/2022 
Date of Study Completion (India) 10/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Present work is a case control study for which 62 subjects had been recruited in each group to assess the possible causes of CKD especially in context of Rakta- Meda vitiating diet. In case group, diagnosed patients of CKD in accordance with KDIGO criteria, age ≥20 yrs. and chronicity ≤1 yr. were enrolled. Whereas in control group age and gender matched healthy individuals were selected. A closed ended questionnaire containing demographic details, potential dietary and lifestyle factors on the basis of classics and relevant examinations was prepared and used for data collection. For case subjects, already carried out laboratory investigations (to diagnose CKD) had been documented. However, in control group hemoglobin, complete blood count, fasting blood sugar, lipid profile, renal profile, urine routine and microscopic investigations were carried out to rule out any metabolic and renal diseases.

Obtained data from survey of case and control groups had been presented in tabular form and statistical tests such as chi square, odds ratio, confidence interval (CI) and logistic regression analysis were applied and interpreted. In this study, maximum participants observed were of age group 61-70 yrs. (case and control- 30.64% each), male (case and control- 59.67% each), Hindu (case-88.7%, control- 96.77%), married (case- 88.7%, control- 91.93%), urban resident (case- 80.64%, control- 91.93%), Jangala Desha (case- 98.38%, control- 100%), secondary education (case- 35.48%, control- 22.58%), housewife (case- 37.09%, control- 32.25%), lower middle and middle class (case- 45.16% each, control- 17.74% and 80.64% respectively), insidious onset of disease (case- 61.29%), diabetic (case- 43.54%), hypertensive (case- 80.64%), positive family history of type â…¡ DM (case- 20.96%, control- 4.83%) and HTN (case- 16.12%, control- 6.45%).

On comparing the probable causative factors from case and control groups following remained highly significant or significant: 1) Rakta vitiating factors- Frequent or regular intake of black gram (p - 0.0405), food that cause burning sensation (p - 0.0162), food that is sharp in nature (p - 0.0028), salty food (p - 0.0063) and mid-day sun exposure (p - 0.0212) were observed. 2) Meda vitiating factors- Frequent or regular intake of non-veg diet (p -0.0006), Guru Guna dominant diet (p - 0.0000), deep fried food (p - 0.0000), fine flour products (p - 0.0055), buffalo or full fat milk (p - 0.0102), curd (p - 0.0027), fish (p - 0.0209) and positive family history of type â…¡ diabetes mellitus (p - 0.0135) were found.

Based on this study it can be concluded that, as kidney is formed by Rakta and Meda Dhatu, dietary and lifestyle factors vitiating them can contribute to development, manifestation and progression of CKD. Therefore, null hypothesis is rejected and alternative hypothesis i.e., there is positive association between Rakta- Meda vitiating diet and CKD is accepted.

 
Close