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CTRI Number  CTRI/2026/01/100237 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on Unhealthy Diet Patterns in Prediabetic and Diabetic Individuals 
Scientific Title of Study   Prevalence of Unhealthy Dietary Patterns Among Prediabetic and Diabetic Individuals: A Cross-Sectional Study 
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 Kokila K 
Designation  PG Scholar 
Affiliation  All India Institute of ayurveda  
Address  622,6th floor All India Institute of ayurveda matura road sarita vihar new delhi 110076

South
DELHI
110076
India 
Phone  8778429217  
Fax    
Email  kokilakvs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramavtar sharma 
Designation  Associate professor 
Affiliation  All India Institute of ayurveda  
Address  608,6th floor All India Institute of ayurveda matura road sarita vihar new delhi 110076

South
DELHI
110076
India 
Phone  9773524621  
Fax    
Email  dr.rsharma@aiia.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Kokila K 
Designation  PG Scholar 
Affiliation  All India Institute of ayurveda  
Address  622,6th floor All India Institute of ayurveda matura road sarita vihar new delhi 110076

South
DELHI
110076
India 
Phone  8778429217  
Fax    
Email  kokilakvs@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF AYURVEDA SARITA VIHAR GAWTHAPURI AWAS NEW DELHI ,110076 INDIA 
 
Primary Sponsor  
Name  All India Institute of ayurveda  
Address  All India Institute of Ayurveda Gawtapuri Sarita Vihar New Delhi 110076 INDIA 
Type of Sponsor  Government medical college 
 
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 Kokila K  All India Institute of ayurveda   622, department of Swasthavritta, All India Institute of Ayurveda (AIIA) Mathura Road, Gautam Puri, Sarita Vihar, New Delhi – 110076
South
DELHI 
8778429217

kokilakvs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIA Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E08-E13||Diabetes mellitus. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Demographic Characteristics
Adults aged 30 to 60 years
Both males and females
2. Study Specific Variables
Diagnosed with prediabetes and diabetes based on American Diabetes Association
Prediabetes
Fasting Plasma Glucose 100 to 125 mg per dL
Postprandial Plasma 140 to 199 mg per dL
HbA1c: 5.7 to 6.4 percent
Type 2 Diabetes Mellitus
FBS greater than or equal to 126 mg per dL
or HbA1c greater or equal to 6.5 percent
or PPBS greater than or equal to 200 mg per dL
3. Participants consuming north Indian food
 
 
ExclusionCriteria 
Details  1. Individuals with diagnosed type I diabetes mellitus
2 Patients with secondary diabetes due to endocrine disorder, steroid use or pancreatic disease
3. Have a history of major systemic diseases, for example, renal failure, chronic liver disease, or heart failure.
4. Are taking long-term steroid therapy or other medications known to influence glucose metabolism.
5 are currently pregnant or lactating, as pregnancy affects metabolism and dietary patterns.
6. Have a known psychiatric illness or cognitive impairment that may compromise their ability to provide accurate dietary and symptom-related responses.
7. Have known food allergies or specific dietary restrictions that significantly alter dietary patterns, for example, celiac disease or severe food allergies.
8. Individuals on special or restricted diets, for example, ketogenic or gluten-free, and habits like smoking

9. Decline to provide informed consent



 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Primary Outcome Measure
The prevalence of unhealthy dietary pattern in prediabetic and diabetic patients.

 
at baseline at the time of enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
2.Secondary Outcome Measures
Association between dietary habits and Srotodushti symptoms in prediabetic and diabetic individuals.

2.Prevalence of medovaha Srotodushti symptoms in prediabetic and diabetic individual
3.Association between physical activity and srotodusti International physical activity questionnaire
4.Descriptive analysis of dietary patterns
Fasting Blood Glucose (FBG) and HbA1c levels correlated with severity of medovaha Srotodushti symptoms.
 
at baseline at the time of enrollment 
 
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   N/A 
Date of First Enrollment (India)   03/01/2026 
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="2"
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  

Title
Prevalence of Unhealthy Dietary Patterns Among Prediabetic and Diabetic Individuals A Cross Sectional Study

 Introduction

The study focuses on diabetes and prediabetes which are metabolic disorders caused by defects in insulin action or secretion. Prediabetes is an early stage of diabetes where blood sugar levels are above normal but not yet diabetic. Dietary patterns play an important role in determining the risk of diabetes. Ayurveda describes Prameha as a disorder caused by improper food and lifestyle leading to obstruction in body channels called srotas. This study aims to assess the association between dietary patterns and Srotodushti in diabetic and prediabetic individuals to develop preventive dietary strategies integrating Ayurvedic and modern approaches.

 Need of the Study

Diabetes and prediabetes are rapidly increasing in both rural and urban areas of India due to lifestyle and diet changes. Research shows that type 2 diabetes can be prevented through proper diet and physical activity. Ayurveda identifies improper food and lifestyle as main causes of Srotodushti leading to Prameha, but few studies have examined this link. Hence, this study is needed to bridge Ayurvedic understanding with modern evidence.

 Literature Review

Classical Ayurvedic texts like Charaka Samhita, Susruta Samhita, and Astanga Hridaya describe the causes, pathogenesis, symptoms, and dietary aspects of Prameha and Srotodushti. They explain how imbalance in doshas and medas leads to disease progression. Modern studies show that unhealthy diets rich in refined carbohydrates, fats, and animal protein increase diabetes risk while diets with fruits, vegetables, and fiber are protective. The literature supports the need to analyze overall dietary patterns and their role in metabolic and Ayurvedic parameters.

According to Sushruta Nidana 6
In individuals indulging in improper diet and lifestyle, the immature doshas vata, pitta, and kapha mix with medas or fat tissue. These vitiated doshas travel through the urinary channels called mutravaha srotas and get localized near the bladder region.                                                                                                                     

 According to Charaka Nidana 4

Due to indulgence in etiological factors, especially kapha-dominant ones, the kapha dosha becomes aggravated and spreads throughout the body. Because of the similarity in properties between kapha and medas, the vitiated kapha mixes with medas, leading to the vitiation of fat tissue. The vitiated kapha and medas then combine with mamsa and kleda, causing the formation of carbuncles and other symptoms. This disturbed fat and moisture also affect the urinary channels, leading to blockage and the manifestation of prameha. As the disease involves multiple dhatus and is deeply rooted, it often becomes chronic and difficult to cure.

 According to Charaka Sutra 28

Premonitory symptoms of prameha, such as excessive urination and obesity, arise from the vitiation of medas. Individuals with disturbed fat metabolism are more prone to develop diabetes in the future. The main causes of medovaha srotodushti include lack of exercise, sleeping during daytime, excessive intake of fatty, fried, and calorie-rich foods, and overconsumption of alcohol.

 According to Charaka Chikitsa

In terms of prognosis, prameha caused by kapha and pitta dosha, when preceded by their early symptoms, is generally incurable. Vata-dominant prameha that occurs in the later stage is also incurable. Pitta-dominant types are manageable but not easily cured. However, when medas is not severely vitiated, the disease can be curable with proper treatment and lifestyle correction.

 

Research Question

Is there an association between dietary pattern and Srotodushti manifestation among prediabetic and diabetic individuals

 Hypothesis

There is an association between dietary pattern and Srotodushti manifestation in prediabetic and diabetic individuals.

 Aim

To evaluate the association between dietary pattern and Srotodushti manifestation in prediabetic and diabetic patients.

 Objectives

To assess the prevalence of unhealthy dietary patterns in prediabetic and diabetic individuals.
To evaluate the relationship between dietary patterns and Srotodushti symptoms.
To study the association of dietary patterns and Medovaha Srotodushti with biological parameters like lipid profile and HbA1c.
To assess the relationship between physical activity and Srotodushti.

 Materials and Methods

This is a two year observational cross sectional study conducted at the Metabolic and Lifestyle Disorder Outpatient Department of the All India Institute of Ayurveda. Convenience sampling will be used. About 200 participants aged 30 to 60 years diagnosed with prediabetes or diabetes will be included. Data will be collected through validated questionnaires on diet, Srotodushti symptoms, and physical activity along with anthropometric and biochemical measurements.

 Questionnaire Development and Validation

The questionnaire will be developed through item generation, response selection, pre testing for face and content validity, and reliability testing using test retest and internal consistency methods.

 Construction of Dietary Pattern by Factor Analysis

A North Indian Food Frequency Questionnaire will be used. Similar food items will be grouped, and factor analysis using varimax rotation will identify dietary patterns. Patterns with eigen value greater than one will be retained. Factor scores will indicate adherence to specific patterns.

 Data Collection

Information will be collected through dietary assessment, Srotodushti symptom questionnaire, physical activity evaluation, anthropometric measurements, and biochemical tests like HbA1c, fasting and postprandial glucose, and lipid profile. Data will be entered electronically after informed consent.

 Sample Size Calculation

Using a 95 percent confidence level and 7 percent precision, the required sample size is 196. Considering 10 percent dropout, the final sample size is fixed at 200 participants.

 Statistical Analysis

Descriptive statistics will summarize the data. Normality will be tested using Shapiro Wilk test. Correlation and regression analyses will examine associations between dietary pattern, Srotodushti symptoms, and biochemical parameters. ANOVA or Kruskal Wallis tests will compare groups based on severity of Medovaha Srotodushti.

 Inclusion Criteria

Adults aged 30 to 60 years of both genders.
Diagnosed with prediabetes or type 2 diabetes based on American Diabetes Association criteria.
Participants consuming North Indian food.

 Exclusion Criteria

Individuals with type 1 or secondary diabetes, major systemic diseases, long term steroid use, pregnancy, psychiatric illness, special diets, food allergies, or those unwilling to participate will be excluded.

 Assessment

Srotodushti assessment will include subjective symptoms, objective clinical findings, and standard diagnostic criteria for prediabetes and diabetes. Biochemical investigations will include HbA1c and lipid profile.

 Standard Operating Procedures

Blood samples will be collected by trained personnel under sterile conditions. Samples will be stored and processed as per standard guidelines. Biomedical waste will be disposed of according to institutional policy.

 Outcome Measures

Primary outcome is the prevalence of unhealthy dietary patterns in diabetic and prediabetic individuals.
Secondary outcomes include association between diet, physical activity, and Srotodushti symptoms along with biochemical indicators.

 

Observation and Results
Baseline data will include demographic, dietary, physical activity, and biochemical parameters. Scores will be computed for dietary behavior, physical activity, and Srotodushti severity.

 Ethical Considerations

Informed consent will be obtained. Participants’ privacy and data confidentiality will be maintained. There are no significant risks except mild discomfort during blood sampling. The study follows ethical guidelines and ensures voluntary participation without financial benefits.

 Translational Value

This research connects Ayurvedic understanding of Srotodushti with modern clinical findings like HbA1c. It aims to identify early metabolic disturbances and provide holistic preventive strategies to reduce diabetes risk.


 
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