| CTRI Number |
CTRI/2023/02/049866 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
19/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Safety and efficacy of fasting among Diabetic population |
|
Scientific Title of Study
|
"Safety and efficacy of fasting therapy
among type 2 diabetes mellitus patients: Randomized
control trial." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep MK Nair |
| Designation |
Professor and Head |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal |
| Address |
Sant Hirdaram medical college of Naturopathy and Yogic sciences for women, Lake road Bairagarh
Sant Hirdaram Yoga and Nature cure Hospital ,one tree hill, Bairagarh
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9823262179 |
| Fax |
|
| Email |
drpradeep18bnys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep MK Nair |
| Designation |
Professor and Head |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal |
| Address |
Sant Hirdaram medical college of Naturopathy and Yogic sciences for women, Lake road Bairagarh
Sant Hirdaram Yoga and Nature cure Hospital ,one tree hill, Bairagarh
MADHYA PRADESH
462030
India |
| Phone |
9823262179 |
| Fax |
|
| Email |
drpradeep18bnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep MK Nair |
| Designation |
Professor and Head |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal |
| Address |
Sant Hirdaram medical college of Naturopathy and Yogic sciences for women, Lake road Bairagarh
Sant Hirdaram Yoga and Nature cure Hospital ,one tree hill, Bairagarh
MADHYA PRADESH
462030
India |
| Phone |
9823262179 |
| Fax |
|
| Email |
drpradeep18bnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 9, Department of research,Sant Hirdaram yoga and nature cure hospital,one tree hill, pincode 462030 |
|
|
Primary Sponsor
|
| Name |
Sant Hirdaram yoga and nature cure hospital |
| Address |
Room no 9, Department of research,Sant Hirdaram yoga and nature cure hospital,one tree hill, pincode 462030 |
| Type of Sponsor |
Private medical college |
|
|
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 Pradeep MK Nair |
Sant Hirdaram yoga and nature cure hospital |
Room no 9, Department of research, One tree Hill, Bairagarh, Bhopal
Bhopal
MADHYA PRADESH |
9823262179
drpradeep18bnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sant Hirdaram Medical College of Naturopathy and yogic Sciences Bhopal |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Juice Fasting along with yoga and Naturopathy treatments |
8 days of juice fasting on various vegetable juices , soups.
200-300 ml Juices will be given 5 times in a day orally
Naturopathy treatments and yoga on all 8 days |
| Comparator Agent |
Normal low calorie diet along with yoga naturopathy treatments |
A normal Indian diet will be given to the control group that includes grains, vegetables and chapatis
it will be given 3 times in a day .
Naturopathy treatments and yoga will be given in all 8 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus
Age between 35 to 65 years
Willing to fast and give consent
|
|
| ExclusionCriteria |
| Details |
Any type of Diabetes related complications like nephropathy, retinopathy and neuropathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting blood sugar
post prandial blood sugar
Diabetes related quality of life questionnaire
|
Day 1(before fasting) and day 9(after fasting) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Urine ketone bodies
Uric acid
Urine PH
|
Day 3 of fasting and day 8 of fasting |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
28/02/2023 |
| 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="0"
Months="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - silwalkarishma2018@gmail.com
- For how long will this data be available start date provided 06-02-2023 and end date provided 09-07-2048?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Diabetes mellitus is considered a growing epidemic in India with more than 62 million people affected by diabetes mellitus. Numerous therapies are proposed to be beneficial in the management of diabetes mellitus. Diet therapy is considered one of the most useful complementary and alternative medicine modalities used in the management of diabetes. Therapeutic fasting one of the modified dietary regimens is thought to be beneficial in glycemic control. However, the data on the safety of therapeutic fasting in diabetes mellitus patients. The present study explores the safety and efficacy of fasting therapy in diabetes mellitus patients. |