| CTRI Number |
CTRI/2024/05/066642 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evalute the efficacy of Masooradi Yoosha in Knee Osteoarthritis
|
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Masooradi Yoosha in Janusandhigata Vata with special reference to 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 |
Dr Ravi Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
room no 202 PG Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9555554077 |
| Fax |
|
| Email |
drravikumar786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
room no 202 PG Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Jaipur
RAJASTHAN
302002
India |
| Phone |
9555554077 |
| Fax |
|
| Email |
drravikumar786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
room no 202 PG Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Jaipur
RAJASTHAN
302002
India |
| Phone |
9555554077 |
| Fax |
|
| Email |
drravikumar786@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan India 302002
|
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
OPD no 21 Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 |
| Type of Sponsor |
Government 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 Vishnu Kumar Jajoriya |
National Institute of Ayurveda Hospital Jaipur |
OPD no 21 department of swasthavritta Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN |
9785256314
vishjajo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Abha Guggulu, Reference: bhaishjya ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Dashmoola kwath), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Masooradi Yusha, Reference: Sharangdhar samhita madhyam khand chapter 2 shlok no 156, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: - Dashmool kwath), Additional Information: abha guggulu also given |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign consent form for the clinical trial
Patients between to age group of 40-70 years irrespective of sex and socioeconomic status
Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radio graphic criteria
ACR clinical classification criteria for osteoarthritis of the knee
Patients having chronicity less than 10 years |
|
| ExclusionCriteria |
| Details |
Patients having severe joint deformities
Patients suffering from paralysis whole body paralysis.
Patients having any type of arthropathy other than osteoarthritis such as neoplasm of spine ankylosing spondylitis Traumatic arthritis pyogenic osteomyelitis gout
Patients having associated cardiac disease tuberculosis malignancy
Chronicity of Sandhigata Vata of more than 10 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Knee injury and Osteoarthritis Outcome Score KOOS
Assessment Criteria:
It will be done on the basis of changes in before treatment and after treatment KOOS score.
|
at baseline and after every 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Need of study:
Osteoarthritis is the second most common Rheumatological problem and it
is the most frequent joint disease with a prevalence of 22% to 39% in India.
Most cases of OA have no known cause and are referred to as primary OA. Primary
osteoarthritis is mostly related to aging. It can present as localized,
generalized, or as erosive OA. Secondary osteoarthritis is caused by another
disease or condition.
OA is more common in women than men, but the prevalence increases
dramatically with age (4). Nearly, 45% of women over the age of 65 years have
symptoms while radio-logical evidence is found in 70% of those over 65 years.
A comprehensive evaluation of three research indicated that the
Mediterranean diet is good for osteoarthritis and joint health. Such type of
diets reduces inflammation, prevents weight gain, and improves health for
osteoarthritis sufferers.
Aim and Objectives:
Aim: To study the
effects of Masooradi Yoosha in
patients of JanuSandhigata Vata (Knee Osteoarthritis).
Objectives: To compare the
effects of Masooradi Yoosha with Abha Guggulu and Dashmool
Kwath in patients of Janu Sandhigata Vata (Knee Osteoarthrit)
Research Question:
1.What is the effect
of Masooradi Yoosha in the patients of
Janusandhigata Vata disease (Knee Osteoarthritis) ?
2. Whether the
Masooradi Yoosha has any augmenting effect when used with Ayurvedic drugs for
treatment of Janu Sandhigata Vata (Knee osteoarthritis)?
Null Hypothesis: There is no
effect of Masooradi Yoosha in patients of Janu Sandhigata Vata (Knee Osteoarthritis) |