| CTRI Number |
CTRI/2025/03/081844 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the efficacy of medicated oil bandage and medicated oil gauze application in Knee Osteoarthritis. |
|
Scientific Title of Study
|
Efficacy of Janu Patch and Janu Pichu Bandhana in Janu Sandhigata Vata: A Non-Inferiority Study |
| 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 Somnath Meher |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan KARNATAKA 573201 India |
| Phone |
7008089150 |
| Fax |
|
| Email |
somnathsomu3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr B A Lohith |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan KARNATAKA 573201 India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr B A Lohith |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan KARNATAKA 573201 India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital,
Thanniruhalla, Hassan 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Thanniruhalla, Hassan 573201 |
| 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 |
| Dr Somnath Meher |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL |
OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, Hassan 573201 Hassan KARNATAKA |
7008089150
somnathsomu3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
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 | - | Janu Patch | (Procedure Reference: -, Procedure details: Janu Patch is prepared with absorbing luke warm Mahanarayana Taila with polyethylene absorbent and applied to affected knee joint for 8hrs per day.) (1) Medicine Name: Mahanarayana Taila , Reference: Bhaishajya Ratnavali Vatarogadhikara Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Janu Pichu Bandhana | (Procedure Reference: -, Procedure details: Janu Pichu Bandhana is done with absorbing cotton gauze with luke warm Mahanarayana Taila and applied all around the affected knee joint and bandaged for 8hrs per day.) (1) Medicine Name: Mahanarayana Taila , Reference: Bhaishajya Ratnavali Vatarogadhikara Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with features of Sandhigata Vata in unilateral or bilateral Janu Sandhi.
2. Subjects willing to sign consent form.
3. Subjects fit to undergo Janu Patch and Janu Pichu Bandhana. |
|
| ExclusionCriteria |
| Details |
1. Subjects with any other systemic disorders like HIV, HBsAg.
2. Traumatic cases like fracture.
3. Diagnosed cases of Vatarakta and Amavata. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters
1. Sandhi Shotha
2. Sandhi Shoola
3. Sandhi Graha
4. Akunchana Prasaranayoh Vedana
5. Sandhi Sphutana
6. Sparsha Asahyatwa
Objective Parameters
1. Range of movement: measured using goniometer
2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve lifestyle. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
18/03/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In India, Osteoarthritis affects approximately 15 million adults
annually, with a prevalence ranging from 22% to 39%. This
degenerative joint condition is the most common form of arthritis which causes
pain, swelling, and stiffness, significantly impacting a person’s ability to
move freely. It affects the entire joint, including surrounding tissues, and is
most prevalent in the knees, hips, spine, and hands. Factors contributing to
its development includes a history of joint injury or overuse, older age, and
being overweight. Notably, 73% of subjects with osteoarthritis are older than
55 years, and 60% are female. In Ayurveda, the disease Sandhigata
Vata resembles with Osteoarthritis, which is described under Vata Vyadhi.
The knee is the most frequently affected joint, followed by the hip and the
hand. The treatment approach for Sandhigata Vata involves specific
therapeutic methods, including Snehana (oleation), Upanaha (local
poultice), Agnikarma (thermal cauterization), Bandhana
(bandaging), and Mardana (massage).
Janu Pichu Bandhana, an external therapeutic procedure where Snehana and
Bandhana is done concurrently. It is derived from Shiro Pichu which
falls under the category of Moordhni Taila treatments. Among these Moordhni
Taila, Pichu is particularly more effective compared to abhyanga
(oil massage) and seka (pouring of medicated liquids). Here
an effort has been made to modify the conventional Janu Pichu Bandhana
in the form of Janu Patch to make it more convenient for application and
also to see the effectiveness of Janu Patch with that of Janu Pichu
Bandhana. If this Janu Patch demonstrates positive effect on Sandhigata
Vata, then it may potentially replace the conventional Janu Pichu
Bandhana.
Mahanarayana Taila is derived from a blend of potent
herbs and processed in Tila Taila, this therapeutic oil can be used in
various ways and offers multifaceted benefits for Vata Rogas. Mahanarayana
Taila exhibits Brimhana properties, pacifies Vata
dosha, acts as Balya and provides relief from Amaya.
Hence, all these positive outcomes make it the gold standard dravya for
managing Janu Sandhigata Vata.
Although Janu Pichu Bandhana
is widely practiced, there is no sufficient research has been done on this
procedure. Thus, for current study Janu Pichu Bandhana and development
of Janu Patch is taken for managing Janu Sandhigata Vata. |