| CTRI Number |
CTRI/2024/05/067783 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Yoga Therapy and Virechana Therapy in the Management of Diabetes-II |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Yoga Therapy (Laghu Shankha Prakshalana) and Virechana Therapy in the Management of Madhumeha (Diabetes Mellitus-II) |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonika |
| Designation |
Ph.D Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Panchakarma,
Faculty of Ayurveda,
IMS, BHU,
Varanasi,
Sir Sunderlal Hospital,
Department of Panchakarma,
Faculty of Ayurveda,
IMS, BHU, INDIA.
BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7206992535 |
| Fax |
|
| Email |
Kaushik1998@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Srivastava |
| Designation |
Assistant Pfofessor |
| Affiliation |
IMS, BHU |
| Address |
Department of Panchakarma,
Faculty of Ayurveda,
IMS, BHU,
Varanasi
Sir Sunder Lal Hospital,
OPD 16C,
Department of Panchakarma,
Faculty of Ayurveda,
IMS, BHU,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8052000040 |
| Fax |
|
| Email |
srivast_25@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchan Chowdhury |
| Designation |
Assistant Professor |
| Affiliation |
IMS, BHU |
| Address |
Department of Swasthvaritta and Yoga,
Faculty of Ayurveda,
IMS, BHU,
Varanasi
Sir Sunder Lal Hospital,
Department of Swasthvaritta and Yoga,
Faculty of Ayurveda,
IMS, BHU,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838957169 |
| Fax |
|
| Email |
dr.kanchan.chowdhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital,
Faculty of Ayurveda,
IMS, BHU,
Varanasi-221005.
India
|
|
|
Primary Sponsor
|
| Name |
Department of Panchakarma Faculty of Ayurveda IMSBHU Varanasi |
| Address |
Sir Sunder Lal Hospital,
OPD 16C, Indian Medicine Wing,
Institute of Medical Sciences, Banaras Hindu University,
VARANASI-221005.
India |
| 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 Vijay Kumar Srivastava |
Sir Sunder Lal Hospital |
OPD No-16C, Indian Medicine Wing,
Faculty of Ayurveda,
Institute of Medical Sciences, Banaras Hindu University,
Varanasi-221005.
India
Varanasi
UTTAR PRADESH |
8052000040
srivast_25@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, India |
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-1 Patients of this group will be advised to undergo for Laghu Shankha Prakshalan once and Yogic intervention & Madhumehari Churna for 3 months
Group -2: This group will be advised to undergo for Virachana Therapy once and Madhumehari Churna for 3 months., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 30 to 60 Years
Male and female Participant
HbA1c 6.5 or more
Postprandial Blood Sugar 200mg/dl to 250mg/dl
Fasting Blood Sugar 126mg/dl to 180mg/dl |
|
| ExclusionCriteria |
| Details |
complicated ill patients
Type-1 diabetes patients will be excluded
patients with suffering from any disk disease or knee joint pain
|
|
|
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
Blood pressure
Body Mass Index
|
Three months with the 3 follow-ups of one month each.
The Diabetic Yoga protocol Session will be done for a total period of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
LFT (Liver Function Test)
RFT (Renal Function Test)
Lipid profile
Stress |
BI and at the end trial intervention
The diabetic Yoga intervention session will be done 3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/06/2024 |
| 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="11"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
Yoga
is a centuries-old science of healthy living and is now recognized as a system
of medicine along with naturopathy by the Ministry of Ayush, India. Nowadays,
Yoga has emerged as one of the important disciplines of healthcare for the
achievement of overall well-being all over the world. 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 “joinâ€. 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). [[i]] Yoga therapy has numerous health
benefits that lead to improved mental and physical balance, agility, improves
blood circulation and control lifestyle disorder. Type-II diabetes now emerged
as a greater health concern in the 21st century and is always
associated with major risk factors. The approaches to the management of type-2 diabetes
(T2DM) are still not up to the mark in modern medicine and it is always
associated with adverse consequences. It
affects 80%–90% of all people living with type II diabetes. The past three decades have witnessed an epidemic of
diabetes (especially T2DM) and more than 80% of the people with diabetes
currently live in developing countries. Yogic
therapy and Virechana therapy are proven methods of
stabilizing an individual from hypertension, metabolic disorder, and lifestyle
disorder. Thus,
it has a significant effect on stress, anxiety, depression, lifestyle disorders,
and type-II diabetes, recent evidence suggests that stress plays a key role in
the genesis of type-II diabetes, hypertension, and other disorders related to the
body. By controlling the blood sugar level through Asanas and pranayama, we can
minimize the exaggerated metabolic activity by decreasing the sugar level. Evidence
suggests that specific Yogic therapy can stimulate pancreatic insulin secretion
or increase the peripheral uptake of glucose. Yogic therapy and Virechana
therapy emerge as a feasible cost-effective tool for type-2 diabetes and
prevent the chances of type-2 diabetes complications like retinopathy, nephropathy,
and cardiovascular disease. Seeing this fact, the current research work will be
conducted in a series of cases of type-2 diabetes under the influence of Yoga
therapy and Virechana therapy to compare its safety.
[i]
Vivekananda, Swami. Patanjali’s Yoga Sutras. Prabhat
Prakashan, 2022.
|