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CTRI Number  CTRI/2023/05/052344 [Registered on: 08/05/2023] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Yoga Practices and Diet Therapy to assess the effectiveness on glycemic control & other health variables in patients of Pre-diabetes 
Scientific Title of Study   A Comparative Study of Yogic Practices and Diet Therapy to assess the effectiveness on glycemic control & other health variables in patients of Pre-diabetes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KAPIL 
Designation  PhD SCHOLAR 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi Sir Sunderlal Hospital Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH 221005 India
Bhagwanpur Chittupur Gate BHU Varanasi UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India 
Phone  9992276400  
Fax    
Email  kapilkv999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr AJAI KUMAR PANDEY 
Designation  Associate Professor  
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH 221005 India
Sir Sunderlal Hospital IMS BHU Varanasi UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India 
Phone  9452827885  
Fax    
Email  drajaipandey@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr KANCHAN CHOWDHURY 
Designation  Assistant Professor  
Affiliation  Banaras Hindu University 
Address  Department of Swasthvaritta and Yoga Faculty of Ayurveda IMS BHU Varanasi
Sir Sunderlal Hospital Faculty of Ayurveda IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India 
Phone  9305356300  
Fax    
Email  dr.kanchan.chowdhury@gmail.com  
 
Source of Monetary or Material Support  
Sir Sunderlal Hospital Faculty of Ayurveda Institute of Medical Sciences BHU Varanasi  
 
Primary Sponsor  
Name  Department of Kayachikitsa Faculty of Ayurveda  
Address  Sir Sunderlal Hospital OPD NO-21 22 Indian Medicine Wing Institute of Medical Sciences Banaras Hindu University Varanasi-221005  
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 
Dr Ajai Kumar Pandey  Sir Sunderlal Hospital   OPD No 21 22 Indian Medicine Wing Department of Kayachikitsa Faculty of Ayurveda BHU Varanasi
Varanasi
UTTAR PRADESH 
9452827885

drajaipandey@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 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:Group-III will be yoga and diet follow , Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmLifestyle--Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:Yoga intervention session will be done for a total period of 3 months Dietary guideline to the experimental group-II, Pathya/Apathya:no, Pathya:, Apathya:
3Intervention ArmLifestyle--Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:This group-I will be advised to Yogic practices, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants with Age range between >30 to <60 years
Male and female participants willing to be part of the study will only considered
Fasting blood sugar ≥ 100 mg/dl & up to 125 mg/dl
Postprandial blood sugar ≥140 mg/dl & up to 199 mg/dl
Participants with HbA1c between ≥ 5.7% & up to 6.4%
 
 
ExclusionCriteria 
Details  Patients suffering from any severe systemic diseases
Age <30 years & >60 years
Fasting blood sugar < 100 mg/dl and >125 mg/dl
Postprandial blood sugar <140 mg/dl and >199 mg/dl
HbA1c between < 5.7% and > 6.4%
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Fasting Blood Sugar
Postprandial Blood Sugar
HbA1c
Lipid profile
BMI (Body Mass Index)
Blood Pressure
 
Three months with 3 follow ups of one month each (Fasting Blood Sugar
The Pre-diabetic Yoga intervention session will be done for a total period of 3 months
Postprandial Blood Sugar
BMI (Body Mass Index)
Blood Pressure )
At BI and at the end trial intervention (HbA1c, Lipid profile)
The Pre-diabetic Yoga intervention session will be done for a total period of 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
LFT (Liver Function Test)
RFT (Renal Function Test)
ECG
General Health The Psychological Distress Manifestation Scale (PDMS) 
BI and at the end trial intervention
The Pre-diabetic Yoga intervention session will be done for a total period of 3 months  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   10/05/2023 
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="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Yoga is a centuries old science of healthy living and now recognize as system of medicine along with naturopathy by Ministry of AYUSH, India. Now a day’s, Yoga is emerged as one of the important discipline of healthcare for the achievement of overall wellbeing all over the world. Seeing its healthcare benefits Yoga day is celebrated every 21st June since, 2015.  It works on all aspects of a person’s health i.e. Physical, Mental, Emotional, and Spiritual health. The word Yoga means unity or oneness and is derived from the Sanskrit word "Yuj", which means to join or to achieve higher level of consciousness. Some experts have suggested that the origin of Yoga could be traced back to the Indus Valley of civilization because in the ruins of the big city of Mohenjo Daro and Harappa excavators found depictions engraved on soapstone seals that strongly resemble Yoga. Maharshi Patanjali, the father of Yoga philosophy, defines Yoga as, “the control of thought waves in the mind in terms of ‘Yogash Chitta Vritti Nirodhah’ (Y.Su. 1.2).”  For this purpose, Maharshi Patanjali has described eight path of yoga. Pre-diabetes is an early stage of type-2 diabetes mellitus, characterised as metabolic disorders of carbohydrates, fats and protein. It is caused by improper act of genetic, environmental, social and mental factors. Pre-diabetes and diabetes now emerged as greater health concern in 21st century and are always associated with major risk factors. The approaches of management of pre-diabetes are still not up to the mark in modern medicine and it is always associated with adverse consequences. At present research scholars are inclined to other system of medicine to solve this health hazard through others system of medicine. In this ways, Yoga system and Dietary therapy are emerged as a feasible cost effective tool to manage pre-diabetes and prevent the chances of occurrence of type 2 diabetes mellitus. Seeing this fact, the current research work will be conducted in series of cases of Pre-diabetes under the influence of few selected Asanas and Pranayama and compare its safety and efficacy with parallel self designed Diet therapy.     

 
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