| CTRI Number |
CTRI/2025/05/086785 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see and compare the effect of ultrasound therapy versus add on effect of tila oil janubasti followed by ultrasound therapy |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study of Add on effect of Tila Tail Janubasti Followed by Ultrasound
Therapy versus Ultrasound Therapy Alone in Pain Management of Janusandhigat Vata with Special
Reference to Knee Osteoarthritis |
| 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 Sanket Rajendrapant Charjan |
| Designation |
PG scholar |
| Affiliation |
APMs ayurved mahavidyalaya, sion |
| Address |
Department of panchakarma, APMs ayurved mahavidyalaya, near sion railway station, sion, mumbai.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9766418103 |
| Fax |
|
| Email |
sanketcharjan01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwajeet Patade |
| Designation |
Professor |
| Affiliation |
APMs ayurved mahavidyalaya, sion |
| Address |
Department of panchakarma, APMs ayurved mahavidyalaya, near sion railway station, sion, mumbai.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet Patade |
| Designation |
Professor |
| Affiliation |
APMs ayurved mahavidyalaya, sion |
| Address |
Department of panchakarma, APMs ayurved mahavidyalaya, near sion railway station, sion, mumbai.
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
|
Source of Monetary or Material Support
|
| seth R. V. Ayurvedic Hospital, Sion |
|
|
Primary Sponsor
|
| Name |
Seth RV Ayurvedic Hospital |
| Address |
Near sion railway station, sion, mumbai, maharashtra, india - 400022. |
| Type of Sponsor |
Other [Government aided] |
|
|
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 Sanket Charjan |
Seth R.V. Ayurvedic Hospital |
Dept. of panchakarma, O.P.D. NO. 1, Near sion railway station, sion, mumbai.
Mumbai
MAHARASHTRA |
9766418103
sanketcharjan01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sion Ayurved college IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Ashtang Hruday sutra sthan, Procedure details: )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Ultrasound Therapy | |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Janusandhigat Vata and exhibiting classical signs and symptoms of knee
osteoarthritis are eligible for the study. The specific criteria are:
1. Both male and female patients.
2. Patients aged between 30 and 60 years.
3. Radiological evidence of osteoarthritis of the knee joint.
4. Presence of pain and restricted movement in the knee joint.
5. Presence of at least one of the following: crepitus, pain, or swelling of the knee joint.
6. Patients must be suitable for Sweda (sudation) therapy.
7. Patients must be eligible for ultrasound therapy.
8. Patients should be willing to adhere to the treatment protocol and follow-up assessments.
9. Patients must provide informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with rheumatoid arthritis, rheumatic fever, rheumatic heart disease, gouty arthritis,
psoriatic arthritis, or sciatica.
2. Patients with congenital or acquired abnormalities affecting the knee joint.
3. Patients with recent or ongoing fractures (simple or compound), ACL tears, or other trauma-
related injuries affecting the knee joint.
4. Patients with a known history of immune-compromised conditions.
5. Patients suffering from infectious conditions such as tuberculosis (TB), carcinoma, or other
serious infections.
6. Patients undergoing systemic steroid therapy or other immunosuppressive treatments.
7. Patients with active local skin infections or dermatitis over the knee joint.
8. Patients with severe cardiovascular, renal, or hepatic conditions that could interfere with the
treatment or assessment.
9. Pregnant or breastfeeding women.
10. Patients with a history of allergic reactions to any of the components used in the treatments. |
|
|
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 |
| sandhishoola |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Akunchan - prasaran vedana, atop, sandhishotha |
7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/05/2025 |
| 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="6"
Days="2" |
|
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
|
Sandhigat Vata is described in the Bruhatrayi under the heading of Vata Vyadhi. The symptoms of this condition resemble those of osteoarthritis and include sandhi shool (pain in the joints), sandhi shoth (swelling over the joints), akunchan prasaran vedana (pain during flexion and extension of the joints), and vata purna druti sparsh (a sensation in the joints akin to the feeling of an air-filled balloon) Janubasti is derived from two words: "janu," meaning knee joint (Janusandhi), and "basti," meaning to reside or to hold . This technique has evolved from the concept of Shirobasti, a type of Murdha Tail . The term "Vas Achhadane" can also be associated with Janubasti. It involves the application or holding of a specific substance at the knee joint (Janu Pradesh) for a considerable period. This procedure is unique as it combines both Snehana (oleation) and Swedana (sudation), and can be considered a form of Snehayukta Sweda (oleation-based sweating therapy) Ultrasound therapy is recognized for its potential in managing musculoskeletal conditions. It is non-invasive, can be performed repeatedly and easily, and has minimal side effects. The Ultrasound therapy mechanism involves applying high-frequency sound waves, which cause mechanical and thermal effects. These effects increase blood flow and metabolic activity while reducing inflammation and pain. Ultrasound therapy helps in softening dense fibrous tissue, resulting in pain-free movement. The ultrasound waves are absorbed by tissues and converted into heat. . |