| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:Group-III will be yoga and diet follow , Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | 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: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:This group-I will be advised to Yogic practices, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
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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. |