| CTRI Number |
CTRI/2024/11/076633 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see and compare effect of Shatawhadi oil and Shwadamshtradi oil administered through rectal route in treatment of Knee joint Osteoarthritis. |
|
Scientific Title of Study
|
A Clinical comparative study of efficacy of Shatawhadi taila with Shwadamshtradi taila matra basti in the management of Janu sandhigata vata w.s.r. to Osteoarthritis of knee joint. |
| 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 Rahul Dadasaheb Karande |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya sion |
| Address |
Department of Panchakarma,second floor, APMs Ayurved Mahavidyalaya, near sion railway station, sion east, Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7208179625 |
| Fax |
|
| Email |
28rahulkarande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved mahavidyalaya sion |
| Address |
Department of Panchakarma,second floor, APMs Ayurved Mahavidyalaya, near sion railway station, sion east, Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved mahavidyalaya sion |
| Address |
Department of Panchakarma,second floor, APMs Ayurved Mahavidyalaya, near sion railway station, sion east, Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya Sion near sion railway station sion east mumbai 400022 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr. Rahul Dadasaheb Karande |
| Address |
APMs Ayurved Mahavidyalaya Sion, Near sion railway statio, sion east, Mumbai - 400022 |
| 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 Rahul Dadasaheb Karande |
Seth R V Ayurvedic Hospital sion |
Department of Panchakarma, OPD no 1, near sion railway station, Sion, Mumbai 400022
Mumbai
MAHARASHTRA |
07208179625
28rahulkarande@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya sion IEC |
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 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Samhita Sidhhisthan Chapter 3 Shlok no 27, Procedure details: Purva karma (pre- operative)
1 Patients vital will be taken.
2 Sthanik snehan with tila oil and sthanik swedana of nitamb,prushta,kati , will be done.
3 Patient will be made to lie in left lateral position.
4 Warm Shwadamshtradi oil of 60 ml will be added in the basti putak (syringe).
5 Lubrication of catheter will be done.
Pradhan karma (operative)
1 Lubricated catheter will be inserted upto the 4.5cm into the anal region parallel to spine.
2 by gently pushing the oil by applying uniform pressure , patient will be asked to take slow deep breath.
3 catheter will be removed slowly.
Paschat karma (Post operative)
1.Pat/massaging of the buttocks will be done.
2.Patient will be asked to sleep in supine position for 10min
)
(1) Medicine Name: Shwadamshtradi oil, Reference: Vangasen Samhita Chapter 60, Vatrogadhikar Shlok no 612, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Samhita Siddhisthan Chapter 3 , Shlok 27, Procedure details: Purva karma (pre- operative)
1 Patients vital will be taken.
2 Sthanik snehan with tila oil and sthanik swedana of nitamb,prushta,kati , will be done.
3 Patient will be made to lie in left lateral position.
4 Warm Shatawhadi oil of 60 ml will be added in the basti putak (syringe).
5 Lubrication of catheter will be done.
Pradhan karma (operative)
1 Lubricated catheter will be inserted upto the 4.5cm into the anal region parallel to spine.
2 by gently pushing the oil by applying uniform pressure , patient will be asked to take slow deep breath.
3 catheter will be removed slowly.
Paschat karma (Post operative)
1.Pat/massaging of the buttocks will be done.
2.Patient will be asked to sleep in supine position for 10min
)
(1) Medicine Name: Shatawhadi Taila, Reference: Charak Samhita Siddhisthan Chapter 4 Shlok no 8, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of both genders
Patient in the age group above 18 years and below 70 years.
Radiological evidences of Osteoarthritis of knee joint.
Pain and restricted movement of the knee joint.
Presence of crepitus, pain and swelling of knee joint. |
|
| ExclusionCriteria |
| Details |
Patients suffering from Rheumatoid arthritis, Rheumatic fever, Rheumatic
Heart disease, Gouty arthritis, Psoriatic arthritis, sciatica
Patient with congenital or acquired abnormality related to joint.
Patients associated with simple or compound fracture, associated with trauma.
K/C/O Immuno compromised patients
Patient suffering from Infective conditions like Hepatitis B, HIV, TB, and carcinoma etc.
Patient undergoing steroid therapy. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain- Visual Analogue Scale (VAS)
Swelling- Girth (in cm) of knee joint with measuring tape
X-Ray Knee joint ap /lat |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sandhi Shotha (Swelling) , Vedana during Prasarana & Akunchana (Pain during extension & flexion), Sandhi Shoola (Pain), Sandhi Atopa (Crepitus) |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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 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
|
Osteoarthritis is the second most common rheumatologic problem and it is the most frequent joint disease with the prevalence rate of Osteoarthritis is total 14.8 % in which knee osteoarthritis prevalence rate is 10.8%. India and 3.62% in the region where I am going to conduct the study. OA is more common in women than men. Nearly, 45% of women over the age of 65 years have symptoms while radiological evidence is found in 70% of those over 65 years.OA was estimated to be the 10th leading cause of nonfatal burden. OA is a major joint involving disease which hampers day to day activity so there is a need for more promising treatment other than pain killers and NSAID’s. To increase the specificity in treatment of Vatavyadhi using various oil preparations mentioned by different Acharya’s so as to improve the quality of life in elderly people |