| CTRI Number |
CTRI/2024/04/066120 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The safety and capability of single diet i.e., grape juice in patients of non-infectious disease |
|
Scientific Title of Study
|
Safety and Efficacy of Monodiet Fasting Using Grape Juice in Patients with Non Communicable Diseases An observational 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 Gulab Rai Tewani |
| Designation |
Professor SHMCNYS |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences |
| Address |
Room number 6, Second Floor, Manu Makhija Bhawan, Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bairagarh, Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7509010110 |
| Fax |
|
| Email |
drgulabtewani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavit Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences |
| Address |
Room number 5, Second floor, Department of Research, Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Behata, Bairagarh, Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7597733931 |
| Fax |
|
| Email |
shmcnys.bhavit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavit Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences |
| Address |
Room number 5, Second floor, Department of Research, Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Behata, Bairagarh, Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7597733931 |
| Fax |
|
| Email |
shmcnys.bhavit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sant Hirdaram Yoga and Nature Cure Hospital, One Three Hill, Bairagarh, Bhopal, India - 462030 |
|
|
Primary Sponsor
|
| Name |
Dr Gulab Tewani |
| Address |
Room number 6 Second Floor Manu Makhija Bhawan Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Bairagarh Bhopal
|
| Type of Sponsor |
Other [Self] |
|
|
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 Gulab Rai Tewani |
Sant Hirdaram Yoga and Nature Cure Hospital |
CMO OFFICE, Ground Floor, 185-190 One tree hill road Sant Hirdaram Nagar Behata Bairagarh
Bhopal
MADHYA PRADESH |
7509010110
drgulabtewani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Sant Hirdaram Medical College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Monodiet Grape Juice Fasting |
The duration of the study is 10 days. Participants will be following a 10 days dietary regimen, comprising normal diet on days 1-2, followed by grape juice monodiet on days 3-7 and concluding with a return to normal diet on days 8-10. |
| Comparator Agent |
Single arm trial |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-75 years with a diagnosed non-communicable disease (e.g., type 2 diabetes, hypertension, cardiovascular disease).
Ability to give informed consent.
Not currently pregnant or breastfeeding.
|
|
| ExclusionCriteria |
| Details |
Participants with severe comorbid conditions requiring immediate medical intervention.
Participants who have history of allergic reactions to grapes or grape products.
Participants who are currently undergoing another dietary intervention study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anthropometric measurements, Body fat analysis, CBC, LFT, Electrolyte levels, FBS, Lipid profile, Serum protein, Urea and Creatinine, Calorie intake, WHO well being questionnaire, Resilience questionnaire, Patient satisfaction score |
Anthropometric measurements - At day 1 and day 10 during intervention
Body fat analysis - At day 1 and day 10 during intervention
CBC - At day 1 and day 10 during intervention
LFT - At day 1 and day 10 during intervention
Electrolyte levels -At day 1 and day 10 during intervention
FBS - At day 1 and day 10 during intervention
Lipid profile - At day 1 and day 10 during intervention
Serum protein - At day 1 and day 10 during intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHO well being questionnaire, Resilience questionnaire, Patient satisfaction score |
At day 1 and day 10 during intervention |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="0"
Months="2"
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
|
This interventional study aims to investigate the impact of 5 days prolonged medically supervised monodiet grape juice fast regimen on Anthropometric measurements, Body fat analysis, CBC, LFT, Electrolyte levels, FBS, Lipid profile, Serum protein, Urea and Creatinine and various clinical variables associated with mono diet grape juice fast among non-communicable diseases. The primary objective is to assess changes in the Anthropometric measurements, Body fat analysis, CBC, LFT, Electrolyte levels, FBS, Lipid profile, Serum protein, Urea and Creatinine, Calorie intake, WHO well being questionnaire, Resilience questionnaire, Patient satisfaction score. The study will be conducted over 2 months, with a simple size of 43 non-communicable disease patients. The intervention involves preparatory fasting for 2 days , followed by 5 days monodiet grape juice fast and followed by refeeding with herbal drink, fruit diet, semi-solid and solid diet. |