| CTRI Number |
CTRI/2025/11/097109 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An interventional study to assess the combined effect of aswakathri taila pana and aswakathri kalka bandhana along with skin foot traction in Osteoarthritis knee |
|
Scientific Title of Study
|
An interventional study to assess the combined effect of aswakathri kalka bandhana and aswakathri taila pana along with skin foot traction in OA knee |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department of Shalyatantra Government ayurveda college Kannur Medical college P O Pariyaram Kannur district Kerala India
Department of Shalyatantra Government Ayurveda college P O Pariyaram Medical College kannur 670503 kerala
Kannur
KERALA
670503
India |
| Phone |
9207503281 |
| Fax |
|
| Email |
gagist1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Gangadharan |
| Designation |
Professor HOD |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department of Shalyatantra Government ayurveda college Kannur Medical college P O Pariyaram Kannur district Kerala India
Kannur
KERALA
670503
India |
| Phone |
9496777170 |
| Fax |
|
| Email |
drkganga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College,Kannur |
| Address |
Department of Shalyatantra Government ayurveda college Kannur Medical college P O Pariyaram Kannur district Kerala India
Department of Shalyatantra Government Ayurveda college P O Pariyaram Medical College kannur 670503 kerala
Kannur
KERALA
670503
India |
| Phone |
9207503281 |
| Fax |
|
| Email |
gagist1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA COLLEGE HOSPITAL PARIYARAM KANNUR KERALA INDIA PIN 670503 |
|
|
Primary Sponsor
|
| Name |
Gayathri S |
| Address |
Goverment ayurveda college kannur medical college p o pariyaram kerala 670503 |
| 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 Gayathri S |
GOVERNMENT AYURVEDA COLLEGE HOSPITAL PARIYARAM |
DEPARTMENT OF SHALYATANTRA GOVERNMENT AYURVEDA COLLEGE HOSPITAL PARIYARAM KANNUR KERALA INDIA PIN 670
Kannur
KERALA |
9207503281
gagist1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe govt ayurveda college Kannur |
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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bandhanakarma, बन्धनकर्म | (Procedure Reference: Susrutha, Procedure details: Swasthika bandhana with aswakathri kalka)
| | 2 | Intervention Arm | Procedure | - | snehapAna-karma, स्नेहपान-कर्म | (Procedure Reference: Susrutha, Procedure details: Samana snehapana with aswakathri taila)
| | 3 | Intervention Arm | Procedure | - | Skin foot traction | (Procedure Reference: Physiotherapy textbook, Procedure details: Skin foot traction done for half an hour using 1/6th of body weight for 2 weeks)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be selected within age group of 40-70 years
Participants presenting with Knee pain and ACR clinical criteria of Osteoarthritis of knee or / and grade 1,2 and 3 according to Kellgren Lawrence index in X ray knee joint |
|
| ExclusionCriteria |
| Details |
Known cases of fractures and ligament injuries,
Subjects with major anatomical defects of knee,
Psoriatic arthritis,
Rheumatoid arthritis,
Septic arthritis,
Gouty arthritis,
Uncontrolled dyslipidemia
Obese, BMI less than 35 |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
WOMAC criteria
Pain,Stiffness,Physical function,ROM,functional mobility , |
on 0th and 22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2025 |
| Date of Study Completion (India) |
03/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Osteoarthritis also known as degenerative joint disease is the most common form of arthritis particularly affecting elderly population. Among them knee joint is one of the most commonly affected joints. It occurs due to progressive loss of cartilage and is characterized by gradual onset of pain, stiffness, swelling, impaired range of movements. Osteoarthritis being correlated with sandhigata vata in Ayurveda is effectively addressed in it. Different modalities of treatment have been mentioned in Susrutha Samhitha for managing Sandhigatavata like Snehana, Abhyanga, Mardana, Svedana, Upanaha,and Bandhana. As Bandhana gives sandhisthairyatha, vedanopasanthi etc and snehanam being a prime treatment for vatavyadhi, both of them are using here along with skin foot traction. A pre and post interventional study was conducted in the OPD and IPD of Shalya Tantra department of government Ayurveda College Kannur to assess combined effect of kalka bandhana and taila pana along with skin foot traction in grade 1, 2 and 3 osteoarthritis knee. Aswakathri (Drynaria quercifolia), a drug which has proven anti-inflammatory, analgesic and anti-osteoarthritic actions through several studies used here for bandhana and tailapana. 37 participants within the age group of 40-70 years were selected through consecutive sampling based on ACR clinical criteria and radiological findings and were divided into 3 groups under grade 1, 2,and 3 of osteoarthritis knee. Participants were given aswakathri kalka bandhana in knee for 1 week and tailapana for 2 weeks. Along with that skin foot traction was done. After doing procedure for 3 weeks participants were assessed based on WOMAC criteria, swelling, pain, ROM and tug test. Scoring was done before and after treatment and outcome variables inferred. The data was statistically analyzed and conclusions wiere drawn. |