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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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. |