| CTRI Number |
CTRI/2025/09/094248 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study to Evaluate the cartilaginous changes with medicated oil enema followed by Poultice in Knee joint Pain |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the cartilaginous changes with Ketakimooladi Taila Matra basti Followed by Vachadi Upanaha Sweda in Janu Sandhigata vata w.s.r Knee joint OA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANIL S MANAGULI |
| Designation |
PhD Scholar |
| Affiliation |
shri N K Jabshetty Ayurvedic Medical College ,PG research Center ,Bidar,Karnataka,India.595401 |
| Address |
Dept of PhD studies in Panchakarma,Shri N K Jabshetty Ayurvedic Medical College,PG research Center, Bidar,Dis- Bidar,Karnataka,pin 585401,India.
Shri J G Co Operative societys Ayurvedic Medical College,Gubbal Gudda,Ghataprabha,Tq-Gokak,Dis- Belagavi,Karnataka.591306.
Bidar
KARNATAKA
585401
India |
| Phone |
9743027164 |
| Fax |
|
| Email |
anil.managuli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channabasavanna B Mashalkar |
| Designation |
Professor & HOD |
| Affiliation |
shri N K Jabshetty Ayurvedic Medical College ,PG research Center ,Bidar,Karnataka,India.595401 |
| Address |
Dept of PhD studies in Panchakarma,Shri N K Jabshetty Ayurvedic Medical College,PG research Center, Bidar,Dis- Bidar,Karnataka,pin 585401,India.
Dept of PhD studies in Panchakarma, Shri N K Jabshetty Ayurvedic Medical College,PG research Center, Bidar,Dis-Bidar,Karnataka,Pin-585401
Bidar
KARNATAKA
585401
India |
| Phone |
7795243335 |
| Fax |
nil |
| Email |
channubm79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil S Managuli |
| Designation |
PhD Scholar |
| Affiliation |
shri N K Jabshetty Ayurvedic Medical College ,PG research Center ,Bidar,Karnataka,India.595401 |
| Address |
Dept of PhD studies in Panchakarma,Shri N K Jabshetty Ayurvedic Medical College,PG research Center, Bidar,Dis- Bidar,Karnataka,pin 585401,India.
Shri J G Co Operative societys Ayurvedic Medical College,Gubbal Gudda,Ghataprabha,Tq-Gokak,Dis- Belagavi,Karnataka.591306.
Bidar
KARNATAKA
585401
India |
| Phone |
9743027164 |
| Fax |
|
| Email |
anil.managuli@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKJabshetty Ayurvedic Medical College and PG research centre, BIDAR,Karntaka, 591403 |
|
|
Primary Sponsor
|
| Name |
Dr Anil S Managuli |
| Address |
Phd and PG Dept Of Panchakarma,Shri N K Jabshetty Ayurvedic Medical College,Gumpa,Bidar,Dis-Bidar, Karnataka.Pin-585401,India. |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 anil Managuli |
N K Jabshetty Ayurvedic Medical College,Bidar. Karnataka. |
Shri N K Jabshetty Ayurvedic Medical college,Gumpa,Bidar,karnataka
Phd Dept of Panchakarma.
Bidar
KARNATAKA |
9743027164
anil.managuli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Sri Chidambaram Shikshana Samstes N K Jabshetty Ayurvedic Medical College and PG Centre Bidar |
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
|
| Type |
Name |
Details |
| Intervention |
Matra Basti with Ketakimooladi and Vachadi Upanaha Sweda. |
Matra Basti with Ketaki Mooladi Taila 72 ml,once in a day in morning empty stomach for 11 days,through Rectal route. Followed by Vachadi Upanaha sweda at evening . The 75 subjects are posted for treatment with duration of 11 days with interval of 22 days(Parihara kala) for three consecutive courses.
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
o Patients suffering from signs and symptoms of Sandhigatavata
Patients between the age group of 40-60 years of either Gender
Baseline score of at least 40 mm on visual analogue scale.
Patients fit for Matrabasti, Upanaha swedana.
|
|
| ExclusionCriteria |
| Details |
Amavata, kostuka shirsha & Vatarakta.
Osteoarthritis secondary to other conditions like trauma, fractures & open wound
Any infective arthritis, Psoriatic arthritis & skin diseases on knee joint.
Patients who are having Diabetes, Hypertension, HIV, HbsAg having Heart related diseases who are on regular medication for disease other than Osteoarthritis
Pregnant woman and lactating mother.
Patients with Metal implants in Knee Joint.
Patients took Intra articular steroid injection in Knee joint Before 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
changes in Janusandhi Ruk (Knee joint Pain),Janusandhi Stambha(Knee joint Stiffness),Cartilage Assessment (Magnetic Resonance Classification),WOMAC index,),Janusandhi Shotha (Knee joint Swelling),Janusandhigati asamarthatha (Restriction in Range of Knee Joint movements),Janusandhi atopa (Crepitus in Knee joint)
|
11 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
changes in Janusandhi Ruk (Knee joint Pain),Janusandhi Stambha(Knee joint Stiffness),Cartilage Assessment (Magnetic Resonance Classification),WOMAC index,),Janusandhi Shotha (Knee joint Swelling),Janusandhigati asamarthatha (Restriction in Range of Knee Joint movements),Janusandhi atopa (Crepitus in Knee joint)
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
18/09/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTERVENTION CHART
|
Ketakimooladi Matarbasti and Vachadi
Upanaha Sweda
|
|
Treatment
Schedule
|
Time
|
Dosage
|
Course of treatment
|
Follow Up
|
|
Maatra
Basti
|
Once in a day
|
70 ml
|
Course
|
Days
|
Before and After each course of treatment follow up is
done. i.e. 1st ,11th, 33rd,44th, 66th,
77th & 100th
day of treatment
|
|
1st course
|
1-11 day
|
|
Upanaha
Sweda
|
Once in a day
|
12 hours
|
2nd course
|
33-44 day
|
|
3rd course
|
66-77 day
|
|