| CTRI Number |
CTRI/2025/02/080779 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Brihatyadi Upanaha Sweda in the Management of Janu Sandhigatavata |
|
Scientific Title of Study
|
Single Arm Clinical study to access the Efficacy of Brihatyadi Upanaha Sweda in the Management of Janu Sandhigatavata |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejaswini Suresh Taksande |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli, Maharashtra 415409 India
Sangli MAHARASHTRA 415409 India |
| Phone |
7350405455 |
| Fax |
|
| Email |
dr.tejaswini4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sonal Shah |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli, Maharashtra 415409 India
Sangli MAHARASHTRA 415409 India |
| Phone |
7972759476 |
| Fax |
|
| Email |
drsonalshah2014@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonal Shah |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli, Maharashtra 415409 India
Sangli MAHARASHTRA 415409 India |
| Phone |
7972759476 |
| Fax |
|
| Email |
drsonalshah2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli 415409 |
|
|
Primary Sponsor
|
| Name |
Tejaswini Suresh Taksande |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center, Urun Islampur, Sangli 415409 |
| 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 Tejaswini Suresh Taksande |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli |
OPD No 1 Kayachikitsa Department Sangli Maharashtra Sangli MAHARASHTRA |
7350405455
dr.tejaswini4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved |
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 | - | upanAhaH (niragniH), उपनाहः (निरग्निः) | (Procedure Reference: Su.Chikitsasthana.4/16, Procedure details: 1. Poorva Karma
2. Pradhana Karma
3. Paschat Karma
Upanaha will be advised to remove after 4 hours of duration.
) (1) Medicine Name: Bhrihatyadi Upanaha Sweda, Reference: Su.Sutrasthana.38/31-32, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(NA), Frequency: od, Duration: 1 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in age group of 50 to 70 years.
2. Patients satisfying the diagnostic criteria. needed for diagnosis of Janu Sandhigatavata.
3. Suitable patients for Swedana theraphy. |
|
| ExclusionCriteria |
| Details |
1. Patient with k/c/o Amavata, Vatarakta.
2. Patient with k/c/o Auto immune disease i.e., Ankylosing Spondylitis.
3. Patient with total knee joint replacement.
4. Patient having skin allergies/disease. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Brihatyadi Upanaha Sweda in the management of Janu Sandhigatavata. |
21 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study Sandhigatavata in detail as per Ayurvedic aspect.
2) To study the role of Upanaha Sweda in Janu Sandhigatavata in detail.
3) To study probable mode of action of Upanaha Sweda, its effect & adverse effect if any. |
12 Months |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="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
|
Sandhigatavata is one of the non-threatening diseases affecting the mobility of multiple joints. Even though multiple joints are affected, knee joints are more prone for damage, since they are weight bearing joints. Mobility is the important feature of life, which is dependent on the structural as well as functional character of the body. As the age advances, though the proper nourishment is available, the body loses its qualitative capacity of the structure and functions. In Ayurveda, Sandhigatavata is not described as a separate disease. It is mentioned by the Acharyas as one of the Vatavyadhi. When age gets older & older undergoes kshaya, which results in Vataprakopa & makes people more prone to a wide range of disease. Sandhigatavata is characterized by symptoms like Sandhishotha (Joint swelling), Vatapurna Druti Sparshah (which is palpable as an air-filled bag) and Prasaaran-Aakunchanayo Pravruttischa Vedana (painful joint movement). Aggravation of Vayu in the joint gives rise to oedema, which on palpation appears as an air-filled bag and pain while making efforts for flexion & extension of the joint. Sandhigatavata is one of the most common Vatavyadhi, which can be correlated with Osteoarthritis, the Prevalence Rate of Osteoarthritis is total 14.8% in which Knee Osteoarthritis Prevalence Rate is 10.8%. Sandhigatavata is the most prevalent type of articular disorder, which restricts daily activities, due to painful joint movements that make the patient disabled. Specially Janu Sandhigatavata is one among the few encounted disease in the hospitals with higher prevalence in India. Sushruta has mentioned Upanaha Sweda in Vataroga. In case of Sankuchita (Contracture), Rujartha (Acute Pain), & Stabdhagatra (Stiffness) Upanaha Sweda is indicated. Upanaha Sweda is one of the types of Swedana which is safe procedure and it can gives good result in Janu Sandhigatavata, due to its Vataghna properties and also due to its Ushna and Snigdha guna it acts against Vata guna like Ruksha, Khara, and Laghu. The toxic metabolic products are eliminated, as a result of the elevated temperature through increased blood flow & perspiration. Upanaha Sweda has been used as the therapy modality. Because of its composition with several drugs that have different properties; it quickly relieves pain and stiffness. Therefore, Upanaha Sweda plays a specific role in the management of Janu Sandhigatavata without affecting the body’s systemic health. |