| CTRI Number |
CTRI/2024/09/073633 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Koladi Upanaha Sweda in Sandhigata Vata (Osteoarthritis) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Koladi Upanaha Sweda in The Management of Sandhigata Vata (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 Kailash Tada |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchakarma Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9414586600 |
| Fax |
|
| Email |
kailashtada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head Of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head Of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Rajasthan INDIA |
| Type of Sponsor |
Government 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 Kailash Tada |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
PG Department of Panchakarma Post
Graduate Institute of
Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University
Jodhpur Nagaur
Road Kadvad Jodhpur
Jodhpur
RAJASTHAN |
9414586600
kailashtada@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M150||Primary generalized (osteo)arthritis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | upanAhaH (niragniH), उपनाहः (निरगà¥à¤¨à¤¿à¤ƒ) | (Procedure Reference: bhavprakash 24/259, Procedure details: The procedure for koladi upanaha sweda involves three stages (poorva karm, pradhan karm, paschat karm).in poorva karma koladi lepa materials are gathers & patient is prepared ,pradhan karm involves applying herbal paste to the effected joints which is than bandaged for 3-6 hours, paschat karm involves removing the bandages and cleaning the joints, this process is repeated for 14 days with the follow up on 21st day)
(1) Medicine Name: koladi lepa, Reference: charak sutrasthan 3/18, Route: Topical, Dosage Form: Lepa Churna, Dose: 300(g), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 20 to 60 years
Patients suffering from Sandhigatavata having classical signs and symptoms as mentioned below
Sandhi Shoola Pain in joints Sandhi Shotha Joint swelling Sandhi Atopa Crepitus Savedana Prasaarana and Aakunchana pravrutti Painful restricted flexion and extension movements of joints
Swedana yogya
Clinical and radiological evidence of OA (Unilateral/ bilateral)
|
|
| ExclusionCriteria |
| Details |
Patients below 20 and above 60 years
Patients with skin diseases and open lesions on affected joints
Patients with diseases such as Gouty arthritis and Rheumatoid arthritis
Swedana ayogya
Patients with systemic disorders like major cardiovascular or renal diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to assess the effect of Koladi Upanaha Sweda on reducing joint pain and stiffness, improving joint mobility, and overall functional ability in patients with Sandhigata Vata (osteoarthritis) |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome includes observing any other effects of the drug & procedure, such as changes in inflammation, patient satisfaction, reduction in the need for conventional medications, & overall quality of life improvements |
21 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="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
|
This study is a single arm open label non randomized trial focusing on the efficacy of Koladi Upanaha Sweda in managing Sandhigata Vata or osteoarthritis The research is conducted at Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University and aims to determine the effectiveness of this therapy in reducing joint pain and improving mobility The study involves a single group of 60 patients who receive the treatment over a period of 14 days with follow ups scheduled on the 21st day The study utilizes traditional Ayurvedic practices by integrating Koladi Upanaha Sweda which is a herbal poultice application to provide a potential alternative to conventional treatments for osteoarthritis The focus is on offering a treatment that emphasizes safety and minimizes side effects by balancing Vata Dosha Through this approach the study aims to explore a natural and holistic method for managing osteoarthritis and improving the quality of life for patients |