| CTRI Number |
CTRI/2025/07/090724 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF SELECTED TREATMENT PROTOCOL INCLUDING AYURVEDIC TREATMENT AND PHYSIOTHERAPY IN TRAUMATIC KNEE INJURIES IN REDUCING PAIN, TENDERNESS, SWELLING AND IN IMPROVING RANGE OF MOVEMENTS OF KNEE JOINT |
|
Scientific Title of Study
|
EFFECT OF SELECTED TREATMENT PROTOCOL IN MENISCAL INJURY OF KNEE JOINT |
| Trial Acronym |
KNET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ASWATHY J |
| Designation |
PG Scholar |
| Affiliation |
GOVT AYURVEDA COLLEGE KANNUR |
| Address |
DEPARTMENT OF SHALYATANTRA, GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA
670503
India |
| Phone |
9744894829 |
| Fax |
|
| Email |
aswathyjkrishna121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreelekha M P |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVT AYURVEDA COLLEGE KANNUR |
| Address |
ASSOCIATE PROFESSOR
DEPARTMENT OF SHALYATANTRA
GOVT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA
670503
India |
| Phone |
7025458190 |
| Fax |
|
| Email |
sreelekaprasanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ASWATHY J |
| Designation |
PG Scholar |
| Affiliation |
GOVT AYURVEDA COLLEGE KANNUR |
| Address |
DEPARTMENT OF SHALYATANTRA, GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA
670503
India |
| Phone |
9744894829 |
| Fax |
|
| Email |
aswathyjkrishna121@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT AYURVEDA COLLEGE HOSPITAL PAIYARAM KANNUR, KERALA INDIA PIN 670503 |
|
|
Primary Sponsor
|
| Name |
Dr ASWATHY J |
| Address |
JALAJAVILASAM KUNDAYATHUKONAM DHANUVACHAPURAM P O PIN 695503
THIRUVANANTHAPURAM KERALA |
| 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 ASWATHY J |
GOVERNMENT AYURVEDA COLLEGE HOSPITAL PARIYARAM |
OPD and IPD of department of shalyatantra
Kannur
KERALA |
9744894829
aswathyjkrishna121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR PARIYARAM MEDICAL COLLEGR PIN 670503 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: JANU-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bandhanakarma, बन्धनकर्म | (Procedure Reference: SUSRUTHA SAMHITHA SUTRA STHANA, Procedure details: MURIVENNA APPLIED OVER AFFECTED KNEE JOINT AND BANDAGE DONE WITH COTTON CLOTH AND COTTON.PATIENT IS ADVICED TO APPLY OIL OVER THE BANDAGE TWICE DAILY.REBANDAGE IS DONE ON EVERY 5TH DAY.TOTAL 14 DAYS OF BANDAGE IS RECOMMENDED)
(1) Medicine Name: MURIVENNA, Reference: THIRUVANANTHAPURAM PHARMACOPEIA , Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Duration: 14 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ganda tailam, Reference: susrutha samhitha, Route: Oral, Dosage Form: Taila, Dose: 15(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 35 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: dhanwanthram kashayam, Reference: sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 90(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 35 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः and isometric exercises | (Procedure Reference: KERALEEYA PANCHAKARMA, Procedure details: Patient is seated on a table, knee joint exposed and extended.Local abhyanga is done over the knee and surrounding area.Janu vasthi yantra is placed over the knee joint which covers the area of maximum tenderness.Janu vasthi yantra is well sealed with masha pishti.Dhanwantharam tailam in sufficient quantity is taken in a small bowel and is made luke warm.Gently poured oil into the janu vasthi yantra and filled it upto half the height of januvasthi yantra.In every 10 minutes after checking temperature of oil, half amount of oil from vasthi yantra is collected out and refilled with new luke warm oil.This procedure is repeated for two more times( total 30 minutes) After that oil is completely removed from janu vasthi yantra by gauze piece.The sealing along with yantra is removed.This procedure is repeated for consecutive seven days.Along with this procedure patient is asked to do static quads and lower leg rotation as isometric exercises
)
(1) Medicine Name: DHANWANTHARAM TAILAM, Reference: ASHTANGA HRIDAYAM, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed as having meniscal injury with MRI
Knee injury within 3 months
Within the age group of 20-50 years irrespective of gender
Positive Thessaly test McMurray test and Apleys grinding test. |
|
| ExclusionCriteria |
| Details |
Associated with fracture in and around the knee joint diagnosed by using Xray
Known cases of tuberculosis muscular dystrophy Neurological diseases
Bucket handle tear |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain
swelling
tenderness
range of movement of knee joint |
asessed on 0th day 36th day and 66th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2025 |
| 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="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
|
This clinical study aims to evaluate the efficacy of an integrated Ayurvedic treatment protocol in the management of meniscal injuries of the knee joint. Meniscal injuries, commonly presenting with pain, swelling, joint line tenderness, restricted range of motion, and functional impairment, are correlated with Janu Marma Abhighata in Ayurveda, where Vata dosha plays a major role in pathogenesis. A total of 19 participants will be selected from the OPD and IPD of the Shalyatantra Department at GAVC Kannur. The 35-day treatment protocol includes Ayurvedic therapies such as Bandhanam, Januvasti, Shashtika Lepam, Ksheera Vasthi, internal medications (Dhanwantharam Kashayam, Gandha Tailam), and physiotherapy (isometric, dynamic, and muscle-strengthening exercises). Outcomes will be assessed based on pain, swelling, tenderness, and range of movement before treatment, on Day 36, and after one month of follow-up. |