| CTRI Number |
CTRI/2024/09/074016 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the Impact of Jatamayadi Choorna Lepa and Wax Bath Therapy in Knee Osteoarthritis: A Randomized Clinical TriaL |
|
Scientific Title of Study
|
To evaluate the effect of Lepa with Jatamayadi Choorna and Wax Bath Therapy in Janu Sandhigata Vata with special reference to Knee Osteoarthritis - A Randomized Comparative Clinical Study |
| 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 Pooja M Goolappanavar |
| Designation |
Post graduate scholar |
| Affiliation |
Dhanvantari ayurveda college ,hospital and research centre , siddapur, uttar kannada |
| Address |
Department of Panchakarma , Panchakarma OPD 101 Dhanvantari ayurveda college hospital and research centre
siddapur
uttar kannada
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9620382882 |
| Fax |
|
| Email |
poojamgoolappanavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahalakshmi KM |
| Designation |
READER AND PG GUIDE DEPT. OF POST GRADUATE STUDIES IN PANCHAKARMA |
| Affiliation |
Dhanvantari ayurveda college ,hospital and research centre , siddapur, uttar kannada |
| Address |
Department of Panchakarma , Panchakarma OPD 101 Dhanvantari ayurveda college hospital and research centre , siddapur
uttar kannada
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9900979629 |
| Fax |
|
| Email |
drmahalakshmi15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja M Goolappanavar |
| Designation |
Post graduate scholar |
| Affiliation |
Dhanvantari ayurveda college ,hospital and research centre , siddapur, uttar kannada |
| Address |
Department of Panchakarma
Panchakarma OPD 101,
Dhanvantari ayurveda college hospital and research centre siddapur
uttar kannada
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9620382882 |
| Fax |
|
| Email |
poojamgoolappanavar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of panchakarma Dhanvantari ayurveda college ,hospital and research centre , siddapur
Uttara Kannada
KARNATAKA
581355
India
|
|
|
Primary Sponsor
|
| Name |
Dr Pooja M Goolappanavar |
| Address |
Department of Panchakarma
Panchakarma opd 101,
Dhanvantari Ayurveda College, Hospital And Research Centre, Siddapur
Uttara Kannada
581355
KARNATAKA,
India |
| 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 Pooja M Goolappanavar |
Dhanvantari Ayurveda Hospital And Research Centre |
Department of Panchakarma Panchakarma OPD 101
Dhanvantari Ayurveda College, Hospital And Research Centre, Siddapur,Uttara Kannada-581355
Karnataka
India
Uttara Kannada
KARNATAKA |
9620382882
poojamgoolappanavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee dhanvantari ayurveda college and hospital |
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, (2) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (3) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (4) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Wax Bath Therapy | Group B: 20 patients are subjected to wax bath therapy POORVA KARMA: 7 units of wax and 1 unit of liquid paraffin will be added to wax bath to lower the melting point and prevent burns .Switch will be turned on half an hour prior to the treatment .Temperature will be checked and maintained to 40 degree Celsius. PRADHANA KARMA: The part to be treated will be cleaned with soap and water and moisture will be soaked with clean, soft towel. Patient will be made to sit or lie in a supine position and expose the knee region adequately. Then the molten wax will be carefully applied to the knees with the help of brush. After making 10 layers the knee part will be wrapped with a cotton cloth to retain the heat for 20 minutes. PASCHAT KARMA: Cotton cloth will be unwrapped and wax will be removed and placed back in wax bath unit for further use. Knee region will be inspected for any allergy or burns. Knee region will be cleaned with a cotton piece. Patient will be allowed to rest for 15 min. | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: sahasrayoga ,sharangadhara, sushruta samhita, , Procedure details: Group A: 20 patients will be subjected to lepa with jatamayadi choorna POORVA KARMA: Preparation of the medicine- 10 gm of Choorna used for lepa will be added with required quantity of hot water to make it into fine paste & will be kept ready. Preparation of the patient – The part to be treated will be cleaned with soap & water and moisture will be soaked with clean, soft towel. In the beginning of procedure svastivachana mantra will be chanted. Patient will be asked to sit with legs extended or made to lie down in a supine position with knee region adequately exposed. Patient will be advised to keep his /her body relaxed and concentrate on the procedure. PRADHANA KARMA: Lepa will be applied in the upward or opposite direction to hair follicles with thickness of about 3mm, covering the whole part of knee and will be removed before it gets dried off completely. PASCHAT KARMA: a) Gentle wiping of the knee with soft cotton dipped in sukoshna jala . b) Patient will be allowed to rest for 15 min. )
(1) Medicine Name: Jatamayadi lepa, Reference: Sahasrayoga taila prakarana , Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 7 Days |
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|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with either sex between the age group of 40-70 years being diagnosed as janusandhigata vata.
Patients suffering from Janu sandhigata vata having classical signs and symptoms .
Janu Sandhi Shoola - Pain in knee joint
Janu Sandhi Shotha - knee joint swelling
Janu Sandhi Atopa - Crepitus in knee joint
Savedana Prasarana Akunchana Pravrutti – Painful or restricted flexion and extension movements of knee joint
Patients fit for lepa.
Patient fit for wax bath therapy. |
|
| ExclusionCriteria |
| Details |
Patients with skin diseases, open lesions on knee, and infections.
Patients with impaired skin sensation like hypoesthesia, hyperesthesia.
Patients with disease such as rheumatoid arthritis, gouty arthritis.
Patients with any other systemic disorders which may interfere with the course of treatment will be excluded |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in sandhishoola/severity of joint pain measured with VAS scale
Reduction in sandhi shotha measured in cms
Improvment in range of movements measured with Goniometer reading
Reduction of crepitus
|
0th day i. e before treatment, 8th day- After treatment and follow up will be done on 15th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvment in overall signs and symptoms of sandhigata vata and improvment in the quality of life |
0th day i. e before treatment, 8th day- After treatment and follow up will be done on 15th day.
|
|
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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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="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
|
Management of janusandhigata vata (knee osteoarthritis) in the age group of 40-70 years for a period of 7 days. During this period 40 patients diagnosed with janusandhigata vata will be divided into 2 groups of 20 patients.Group A patients will be subjected to lepa with jatamayadi choorna and Group B will be subjected to wax bath therapy for 7 days. patients will be assessed for primary outcome as reduction in sandhishoola ,sandhishotha,sandhi atopa and improvement in range of movements. Secondary outcome measure will be improvement in overall signs and symptoms of janusandhigata vata and improvement of quality of life of the patient. grading will be given for subjective and objective criteria after the assessment on 0th day-before the treatment ,8th day-after the treatment and follow up will be done on 15th day . The data obtained will be analysed statistically with suitable method. |