| CTRI Number |
CTRI/2024/09/074252 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of balance diet versus low carb diet in enhancing pain in knee Osteoarthritis |
|
Scientific Title of Study
|
Effect of balance diet versus low carb diet in enhancing pain in knee Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha |
| Designation |
Assistant Professor |
| Affiliation |
Maharaj Vinayak Global University |
| Address |
Maharaj Vinayak Global University.
Department of Physiotherapy. First Floor.
H-11C, Delhi - Jaipur Expressway, Dhand, Tehsil - Amer.
Jaipur
RAJASTHAN
302008
India |
| Phone |
9818095610 |
| Fax |
|
| Email |
manisha.physio89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manisha |
| Designation |
Assistant Professor |
| Affiliation |
Maharaj Vinayak Global University. |
| Address |
Maharaj Vinayak Global University. H-11C, Delhi - Jaipur Expressway, Dhand, Tehsil - Amer.
Department of Physiotherapy. First Floor.
Jaipur
RAJASTHAN
302008
India |
| Phone |
9818095610 |
| Fax |
|
| Email |
manisha.physio89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha |
| Designation |
Assistant Professor |
| Affiliation |
Maharaj Vinayak Global University |
| Address |
Maharaj Vinayak Global University. H-11C, Delhi - Jaipur Expressway, Dhand, Tehsil - Amer.
Department of Physiotherapy. First Floor.
Jaipur
RAJASTHAN
302008
India |
| Phone |
9818095610 |
| Fax |
|
| Email |
manisha.physio89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaj Vinayak Global University. H-11C, Delhi - Jaipur Expressway, Dhand, Tehsil - Amer. Jaipur, Rajasthan 302028
Department of Physiotherapy. First Floor. |
|
|
Primary Sponsor
|
| Name |
Manisha |
| Address |
Maharaj Vinayak Global University. H-11C, Delhi - Jaipur Expressway, Dhand, Tehsil - Amer. Jaipur, Rajasthan 302028
Department of Physiotherapy. First Floor. |
| 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 Manohar Bhatt |
Maharaj Vinayak Global Hospital |
Maharaj Vinayak Global University Campus, First Floor.
Dhand Kukas. H-11C, Delhi - Jaipur Expressway, Dhand, Tehsil - Amer. Jaipur, Rajasthan 302028
Jaipur
RAJASTHAN |
9785400219
president@mvgu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharaj Vinayak Global Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Balance Diet |
Effect of Balance diet will be compared with effect of low carb diet in pain in OA knee. |
| Intervention |
Low Carb |
Clinical studies on the benefits of low-carb diets for reducing pain in knee osteoarthritis are rare. As far as we are aware, no prospective, randomized research exist examining the efficiency of a low-carb diet in reducing osteoarthritis knee pain in the literature. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
They had screening for Osteoarthritis for greater than 6 months and reported pain in knee joint in physiotherapy clinic. Subjects already diagnosed with OA knee by orthopaedician. |
|
| ExclusionCriteria |
| Details |
If a person had any cardio or vascular ailment, they were disqualified, or psychological disorder or uncooperative patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS (Numeric Pain Rating Scale) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 - Informed Consent Form
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) - by means of publication
- For how long will this data be available start date provided 30-09-2024 and end date provided 30-09-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Study Design: Pre to
post-test design- experimental study
Background: Clinical
studies on the benefits of low-carb diets for reducing pain in knee
osteoarthritis are rare. As far as we are aware, no prospective, randomized
research exist examining the efficiency of a low-carb diet in reducing
osteoarthritis knee pain in the literature.
Purpose of the study: To
find out whether low-carb or balanced diet is beneficial in relieving knee
osteoarthritis pain.
Method: Twenty patients
with grade 2 or 3 osteoarthritis were allocated to the control or experimental
groups. On the first and last days of the fourth week, readings for the
National Pain Rating Scale (NPRS) were obtained.
Results: The study’s
findings showed that group B’s food plan lessens discomfort more efficiently
than group A’s. By the finish of the fourth week, group B’s NPRS score had
significantly improved (p<0.001) in contrast to group A’s.
Conclusion: The study’s results
indicated that those patients with osteoarthritis in the knee joints have less
pain when following a low-carb diet. |