CTRI Number |
CTRI/2021/09/036744 [Registered on: 22/09/2021] Trial Registered Retrospectively |
Last Modified On: |
14/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Clinical study on a multimodal Ayurvedic intervention protocol in knee joint arthritis |
Scientific Title of Study
|
A pre and post test clinical study on the efficacy of a multi modal intervention based on yogaratnakara treatment protocol in knee joint osteoarthritis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
SREELEKSHMI GU |
Designation |
PG SCHOLAR |
Affiliation |
Amrita School of Ayurveda |
Address |
DEPARTMENT OF KAYACHIKITSA
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA DEPARTMENT OF KAYACHIKITSA
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA Kollam KERALA 690525 India |
Phone |
6282375021 |
Fax |
|
Email |
drsreelekshmisony@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr KRISHNAKUMAR K |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
Amrita School of Ayurveda |
Address |
DEPARTMENT OF KAYACHIKITSA
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA DEPARTMENT OF KAYACHIKITSA
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA Kollam KERALA 690525 India |
Phone |
9446583803 |
Fax |
|
Email |
drkrishnakumarmd@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr KRISHNAKUMAR K |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
Amrita School of Ayurveda |
Address |
DEPARTMENT OF KAYACHIKITSA
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA DEPARTMENT OF KAYACHIKITSA
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA Kollam KERALA 690525 India |
Phone |
9446583803 |
Fax |
|
Email |
drkrishnakumarmd@gmail.com |
|
Source of Monetary or Material Support
|
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA |
|
Primary Sponsor
|
Name |
Amrita school of Ayurveda |
Address |
DEPARTMENT OF KAYACHIKITSA
AMRITA SCHOOL OF AYURVEDA
CLAPPANA PO
KOLLAM
KERALA |
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 |
SREELEKSHMI GU |
Amrita school of ayurveda |
DEPARTMENT OF KAYACHIKITSA
CLAPPANA PO
Kollam KERALA |
6282375021
drsreelekshmisony@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethical committee, amrita institute of medical sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: Janusandhigatavata, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
multi modal intervention on the combined efficacy of external treatments and internal medications
|
Duration - 30 days;
First 5 days
(from 1st to 5th day) - Nirgundi –karanjadi naadi swedam externally and
Sthanika Nirgundi –karanjadi upanaham externally administered.
Next 7 days (from 6th to 12th day) -
Bahya snehana by sthanika abhyanga (external massage and lubrication therapy) and Janu pichu (cotton pad soaked in oil applied over the knee joint) with Narayana thailam ,
and Abhyanthara snehana (Internal lubrication) by Mathra vasthi (oil enema) with Narayana thailam (72 ml after lunch).
From the 1st day to the 30th day - Shamana oushadhi (internal medicines)
- Yogaraja guggulu gulika (Dose: 1 tab tds with Rasna kashaya (decoction) as Anupana - 50 ml)
was given.
|
Comparator Agent |
No Comparator Agent |
Nil |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Diagnosed according to the American College of Rheumatology criteria
2.who have OA of the knee joint
3.Radiologic changes of the knee in the images by the X ray
4.The patients will have reported a mean pain intensity in the affected knee, over the 7 days before baseline assessment
5. who are willing to give written informed consent
6. Having the lakshana of sandhigata vata as per the classic |
|
ExclusionCriteria |
Details |
1.Severe deformities secondary to any other complaints like rheumatoid arthritis , gout etc.
2.Pregnant or Lactating Mothers |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The outcome expected is a change in the score on the WOMAC Index |
Before and after the treatment in 30 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
change of signs and symptoms of sandhigata vata before and after treatment |
Before and after the treatment in 30 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
20/01/2017 |
Date of Study Completion (India) |
30/12/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Osteo
arthritis is the most common joint disease of humans. Among elderly,
knee joint OA is the leading cause of chronic disability in developed
countries. Radiographic evidence of knee OA,is more common in women
than in men1.
Osteoarthritis has symptoms like Pain, Functional restriction,
Joint line tenderness, Muscle wasting, mild synovitis(warmth and
effusion) and Morning stiffness2.
The risk factors for OA includes old age, female sex, race, genetic
factors, major joint trauma, repetitive stress, obesity,
congenital/developmental defects, prior inflammatory joint disease
and metabolic/endocrine disorders 3.
Prevalence of OA in India is reported to be in the
range of 17 to 60.6% 4 . Due
to the increased prevalence of this disorder it has become a major
problem and burden over the society, indirectly reduces the working
capacity of a citizen.
Now-a-days, even in the
adult age itself man is suffering from the degenerative changes
because of the changing lifestyle and food habits. The symptoms of OA
is identical to the Sandhigata vata which is of degenerative and
chronic rheumatic disease in nature explained by Ayurveda. This
disease is known for pain & swelling in the joints giving rise
to the restricted movements and disability that hampers the normal
mobility which is one of the cardinal function of Vata dosha. The
disease exhibits end of variety of patterns of joint failure together
or lesser extent which is always characterized by degeneration of
articular cartilage. It affects women than men, mainly after
menopause, due to the hormonal variations.
Sandhigata vata is a type
of vata vyadhi described in all classics of Ayurveda. Charaka was
first to describe separately “Sandhigate-anilae†where Susrutha ,
Yogaratnakara, Madhava & Bhavaprakasha has described the disease
as “Sandhigatavata†. The provoked Vata affects the Sandhi ,
which resembles a bag filled with air. Vata purna driti
sparsha,Sotha,Vedana on prasarana and Akunchana are told to be the
symptoms by charaka5.
Being the disease of madhyama roga marga
[since
sandhi comes under madhyama roga marga]6
and since it is a dhatukshaya janya vyadhi 7
,the disease becomes kashtasadhya.
The
medical management now available have many limitations and cannot
satisfy the objectives of an ideal therapy. Many research studies
have been done but most of them have
methodological limitations
,and are experimental, focusing on single herbs/ formulations, or
single therapies. Full line of treatment protocol are not yet done
but which is a necessity to found out , since vata is bali and
ashukari, single drug or single kriya krama will be insufficient .
At present era, since this degenerative disease is more prevalent,
which is a cause leading to disability, there is an urgent need for
an effective , safe and less complicated treatment.
|