| CTRI Number |
CTRI/2024/06/068945 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
TO compare the efficacy of Janudhara with Mahabala taila against Ketakyadi taila in managing Osteoarthritis of Knee at different heights |
|
Scientific Title of Study
|
Efficacy of Janudhara with Mahabala taila in comparison to Ketakyadi taila at various heights in the management of Osteoarthritis of Knee- A factorial Randomized Controlled trial |
| 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 SABNA V |
| Designation |
PG Scholar |
| Affiliation |
VAIDYARATNAM P S VARIER AYURVEDA COLLEGE KOTTAKKAL |
| Address |
Department of Panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Malappuram
Kerala-676501
INDIA
Malappuram
KERALA
676501
India |
| Phone |
9656169038 |
| Fax |
|
| Email |
sabnarahoofv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigeesh P P |
| Designation |
Professor & HOD |
| Affiliation |
VAIDYARATNAM P S VARIER AYURVEDA COLLEGE KOTTAKKAL |
| Address |
Department of Panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Malappuram Kerala -676501 INDIA
Malappuram
KERALA
676501
India |
| Phone |
9447997436 |
| Fax |
|
| Email |
drjigeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigeesh P P |
| Designation |
Professor & HOD |
| Affiliation |
VAIDYARATNAM P S VARIER AYURVEDA COLLEGE KOTTAKKAL |
| Address |
Department of Panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Malappuram Kerala -676501 INDIA
Malappuram
KERALA
676501
India |
| Phone |
9447997436 |
| Fax |
|
| Email |
drjigeesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| VAIDYARATNAM P S VARIER AYURVEDA COLLEGE KOTTAKKAL EDARIKKODE PO
MALAPPURAM
KERALA-676501
INDIA |
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda college Kottakkal |
| Address |
VPSV Ayurveda college Kottakkal
Edarikkode P O kottakkal
Malappuram district
Kerala
676501 |
| Type of Sponsor |
Other [Aided 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 SABNA V |
VAIDYARATNAM P S VARIER AYURVEDA COLLEGE KOTTAKKAL |
OPD Department of Panchakarma
Room no A112
Malappuram
KERALA
Malappuram
KERALA |
9656169038
sabnarahoofv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Vaidyarathnam P S Varier Ayurveda College Kottakkal |
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 | - | pariShekasvedaH पhरषेकeेदः | (Procedure Reference: Srikantha murthy. K.R. Susrutha Samhitha.volume2.2 nd edition.choukambha Orientalia; 2005. p.225. Sanskrit, Procedure details: 1.The procedure is to be done in the morning hours after the evacuation of the bowel & bladder.
2. The patient is made to lie down or to sit erect on the Abhyanga table
3. The affected knee joint is properly exposed
4. To begin with, the patient is subjected to local Abhyanga procedure.
5. The bowl containing medicated oil is heated gently by keeping over hot water
6. The lukewarm taila (having bearable warmth to the patient) is poured into the DhÄra pot and made to flow on the JÄnusandhi(knee joint) in a regular, steady stream.
7.The height of the stream should be maintained 12 aá¹…gula(approx.9 inches) throughout the procedure.
8.Mild massage should be done with left hand continuously along with the flowing oil.
9.The medicated oil should be continuously taken and reheated inorder to maintain the temperature throughout the procedure
10. The medicated oil can be used for three days consecutively and fresh oil should be used for three days consecutively and fresh oil should be used on every fourth day of the procedure
11.The medicated oil should be poured for ten thousand MÄtrakÄla(40-50minutes), for 7days.)
(1) Medicine Name: Ketakyadi taila, Reference: Vridha Vagbhata. Ashtangasangraham [Indu, comme]. 2 nd ed. Siva Prasad Sharma,edi. Varanasi:Chaukamba orienatalia; 2008. 571p.Sanskrit, Route: Topical, Dosage Form: Taila, Dose: 1500(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | pariShekasvedaH पhरषेकeेद | (Procedure Reference: Srikantha murthy. K.R. Susrutha Samhitha.volume2.2 nd edition.choukambha Orientalia; 2005. p.225. Sanskrit, Procedure details: 1.The procedure is to be done in the morning hours after the evacuation of the bowel & bladder
2.The patient is made to lie down or to sit erect on the Abhyanga table
3.The affected knee joint is properly exposed
4.To begin with, the patient is subjected to local Abhyanga procedure
5.The bowl containing medicated oil is heated gently by keeping over hot water
6.The lukewarm taila (having bearable warmth to the patient) is poured into the DhÄra pot and made to flow on the JÄnusandhi(knee joint) in a regular, steady stream
7.The height of the stream should be maintained 12 aá¹…gula(approx.9 inches) throughout the procedure
8.Mild massage should be done with left hand continuously along with the flowing oil
9.The medicated oil should be continuously taken and reheated inorder to maintain the temperature throughout the procedure.
10.The medicated oil can be used for three days consecutively and fresh oil should be used for three days consecutively and fresh oil should be used on every fourth day of the procedure
11.The medicated oil should be poured for ten thousand MÄtrakÄla(40-50minutes), for 7days.)
(1) Medicine Name: Mahabala taila, Reference: Chakrapanidatta. Chakradatta [bhavarthasandheepani]. 3 rd ed. Jagadeeshvar prasad tripatee A.M.S, ed.Varanasi; Chowkamba Sanskrit Series Office; 2017.113pSanskrit, Route: Topical, Dosage Form: Taila, Dose: 1500(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants fulfilling the diagnostic criteria
radiological finding of Knee of Grade 2-4 in Kellgren-Lawrence Grading scale
Fit for snigdhasweda
Participants willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Known cases of Rheumatoid and other type of arthritis
Known cases of fracture ligament tear dislocation knee joint infection malignancy
Uncontrolled Diabetes mellitus (FBS greater than or equal to 126 mg/dl on medication)
Obesity greater than Grade 1 of WHO criteria
Pregnant and Lactating Women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
WOMAC Score
Goniometry |
0th, 8th and 15th days
0th, 8th and 15th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Samyak swinna lakshana assessment |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 3 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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 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
|
A factorial randomized controlled trial on the efficacy of Janudhara with Mahabala taila in comparison to Ketakyadi taila done at various heights in the management of Osteoarthritis of knee. Cases will be diagnosed based on The American College of Rheumatology clinical classification criteria of knee of Osteoarthritis. 72 participants will be selected and divided in to 6 groups. The first 3 groups will be treated with Janudhara using Mahabala taila at 3 different height 12 Angula, 4 Angula and 2 Angula. Similarly the other 3 groups will be treated with Ketakyadi taila like wise Assessment will be done by using WOMAC score and Range of movement with Goniometry as outcome measures The assessment will be done on 0th 8th 15th day. |