| CTRI Number |
CTRI/2025/01/079652 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This clinical trial will be performed to understand the effect between Agnikarma and Wax bath therapy in the management of Janusandhi Shoola which include features like pain, stiffness, range of movement of knee joint (Janu Sandhi). |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the efficacy between Agnikarma and Wax bath therapy in the management of Janusandhi Shoola. |
| 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 Kunal Mukundrao Gujarkar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Third floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8888006755 |
| Fax |
|
| Email |
kgujarkar5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Third Floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Third Floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Sector no. 25 Pradhikaran Nigadi Pune
Maharashtra
India
411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
PDEAs College of Ayurved and Research Centre third floor shalyatantra department sector 25 Pradhikaran Nigadi Pune
Maharashtra
India
411044 |
| Type of Sponsor |
Private 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 Kunal Gujarkar |
Ayurved rugnalaya and sterling multispeciality hospital |
Shalyatantra Department,OPD No. 123A,Sector no. 27,Pradhikaran, Nigadi
411044
Pune
MAHARASHTRA |
8888006755
kgujarkar5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: JANUBEDAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut Samhita, Procedure details: 1. One end of tamra shalaka is placed on marked point perpendicular to surface & other end will be heated with candle. 2. Same process is repeated on other marked painful points. 3. Procedure will be stopped when patient feels atmost heat.
Follow up & therapy on 0, 7, 14, 21st day. Duration of the study = 21 days.)
| | 2 | Intervention Arm | Procedure | - | Wax bath therapy | (Procedure Reference: Physiotherapy, Procedure details: Procedure details: 1.Patient made to sit or lie down on the bed. 2.Clean the affected knee joint. 3.Melt the paraffin wax. 4.Apply the melted paraffin wax with the help of spatula. 5.Let it dry. 6.Wipe the dried wax with tissue paper.
Follow up and therapy on 0, 7, 14, 21st day.
Duration of the study = 21 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age of 30 to 70 years irrespective of gender.Patients with Pain, Stiffness, Restricted movement of knee.Patients with Progressive loss of passive range of movement (PROM) and active range of movement (AROM) of knee joint. |
|
| ExclusionCriteria |
| Details |
Patients with history or known case of Fracture, Ligaments tear, Dislocation of knee joint,Knee effusion,Septic arthritis,Tuberculous arthritis,Psoriatric arthritis,Pyoarthrosis,Hemarthrosis,Pregnancy,Uncontrolled DM. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assessed the Pain & Range of movement by Agnikarma and Wax therapy in the management of janusandhi shoola. |
21 days treatment with follow-up on 7th, 14th and 21st day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2025 |
| 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="0"
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
|
Now a days, peoples are facing many joint related disorders. Pain, stiffness and restricted movements of the lower limb joints is very common. Agnikarma is advocated in joint disorders because of its ushna guna and vatakapha subduing property of agni. It is well known instant pain relief modility in ayurveda; as well as Wax therapy is a painless, relaxing treatment. It provides soothing effect in chronic joint pain. There is need to assess the comparison between Agnikarma and Wax therapy in the management of Janusandhi shoola. Hence the topic has been selected for study. |