| CTRI Number |
CTRI/2024/02/063103 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Panchakarma in Knee joint pain |
|
Scientific Title of Study
|
Efficacy of Rasnadi Ghrita Anuvasana Basti in the Management of Janu Sandhigata Vata W.S.R to Knee Osteoarthritis – A Randomised Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri B |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
9003329656 |
| Fax |
|
| Email |
gayathribaskaran97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Professor and HoD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Professor and HoD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Appplicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri B |
KLE Ayurveda Hospital and Medical Research Centre |
Room No 04 and IPD Department of Panchakarma KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi 590003 Belgaum KARNATAKA |
9003329656
gayathribaskaran97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi |
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 | Procedure | - | bastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Caraka Samhita, Procedure details: Anuvasana basti with Guggulu tiktaka ghrita 75 ml through rectal route for 11 days)
| | 2 | Intervention Arm | Procedure | - | bastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Caraka Samhita, Procedure details: Anuvasana basti with Rasnadi ghrita 75 ml through rectal route for 11 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having symptoms of Janu sandhivata (OA of knee joint) such as pain,swelling ,stiffness or crepitus.
Patient having x-ray based on grade (grade 1 to grade 3) of knee osteoarthritis will be taken
Patient of age group between 30 to 70
Patient of either sex will be included .
|
|
| ExclusionCriteria |
| Details |
Patients of rheumatoid arthritis ,ankylosing and traumatic arthritis
Patients suffering from paralysis
Patients having septic arthritis ,tuberculosis ,brucellosis,pyogenic osteomyelitis
Patients having neoplasm of spine
Patients with bony deformity
Patients with uncontrolled diabetes and hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, VAS Scale, Womac Scale, Whoqlbref Scale, |
0th and 11th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/03/2024 |
| 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="2" Months="0" 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
|
Osteoarthritis (OA)
is the most common type of arthritis and is a major cause of pain and
disability in older people[1]. Epidemiological studies have reported that
Arthritis uncommon among adults <40
and highly prevalent of those aged >60[2] and older, and report
says that 22% to 39% have been diagnosed with osteoarthritis. Osteoarthritis is
prevalent more in females than males, and report says that 45% of women above
65 years have osteoarthritis pain and 70% have been diagnosed with radiological
findings[2].
Ageing is
associated with multiple condition of medicine due to deteriorating
physiological actions and impaired metabolic mechanisms. Epidemiological ageing
studies report that non-communicable diseases such as diabetes, arthritis etc.,
are integral part of ageing[2]. There is higher risk of dependency
due to psychological stress.Repetive adverse loading of joints during occupation
or competitive sports ,obesity are also important predisposing factor[3].
Osteoarthritis
is a chronic condition and the main goals of the treatment are to alleviate pain and minimalize loss of
physical function.[2]
The
approach to the management of symptomatic osteoarthritis (OA) in the geriatric
population differs from the approach in younger patients because of the
substantial toxicity of nonsteroidal anti-inflammatory drugs (NSAIDs) in older
patients.[2]
Non-pharmacological interventions should be the
first line of treatment[2].
While
some patients older than 65 can tolerate NSAID use with concomitant protection
from gastrointestinal (GI) bleeding with a proton pump inhibitor (PPI), this
regimen exposes patients to two drugs with numerous potential adverse drug
effects.[2] Intra-articular corticosteroid injections are effective in the
treatment of knee OA and also used for symptomatic relief in treatment of OA at
first CMC joint.[3] But
repeated steroidal injections leads to more cartilage damage .[4]
Evidence
base of anti-neuropathic drugs is also poor. Presently there are no licensed
drugs that can prevent, stop or restrain the progression of OA in modern
medicine. Even up to 30% of individuals continue to experience pain and
disability after total knee joint replacement surgery.[3]
In ayurveda, the
vitiated vata combines with dosha ,dushya circulates throughout the body and
lodges in a particular site and manifests vatavyadhi.[5]
Anuvasana basti is
specifically indicated in the persons who are having dryness in the
body,excessive appetite and suffering from kevala vata disorders.In these
conditions Anuvasana is the first choice.Anuvasana basti can be given directly
without prior administration of niruha basti in the patient suffering from
excessive aggravation of vata.[5]
Rasnadi ghrta is
selected for Anuvasana Basti chikitsa in Janu sandhivata .It contains
Rasna, Dasamoola, Shatavari ,kulatha, Badara, Yava, Ajamamsarasa,and jeevaniya
gana drugs which possess madhura, tiktha, guru, snigdha qualities which
increases the sleshaka kapha and it helps in preventing the degeneration of the
joints .This medicine used in the form of pana ,navana,basti in the diseases
caused by vata . |