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CTRI Number  CTRI/2015/01/005357 [Registered on: 06/01/2015] Trial Registered Retrospectively
Last Modified On: 18/12/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A COMPARATIVE STUDY OF JANU BASTI(indirectly massage therapy)& AGNIKARAMA (Therapeutic Burn) IN THE MANAGEMENT OF JANU SANDHIGATA VATA (Osteoarthritis) 
Scientific Title of Study   A COMPARATIVE STUDY OF JANU BASTI WITH SAHACHAR TAIL & AGNIKARMA WITH TAMRASHALAKA IN JANUSANDHIGATA VATA 
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 manjula shamarao chavan 
Designation  Assistant professor 
Affiliation  bharati vidyapeeth medical foundation of ayurved hospital 
Address  Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43
Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43
Pune
MAHARASHTRA
411043
India 
Phone  9890254424  
Fax    
Email  manjula_chavan@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr manjula Shamarao Chavan 
Designation  Assistant professor 
Affiliation  BVMFs ayurveda hospital pune - 43 
Address  Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43
Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43
Pune
MAHARASHTRA
411043
India 
Phone  9890254424  
Fax    
Email  manjula_chavan@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Surendra M Vedapathak 
Designation  Professor and HOD ( Guide) 
Affiliation  BVMFs ayurveda hospital pune - 43 
Address  Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43
Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43
Pune
MAHARASHTRA
411043
India 
Phone  07030309088  
Fax    
Email  surendra_vedpathak@yahoo.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43  
 
Primary Sponsor  
Name  Bharati Vidyapeeth Medical Foundations ayurved hospital pune  
Address  Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Bharati Vidyapeeth Medical Foundations Ayurved Hospital Pune   Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjula Shamarao Chavan  Bharati Vidyapeeth Medical Foundations Ayurved Hospital Dpt.of Panchakarma OPD No.24 Pune- 43   Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43
Pune
MAHARASHTRA 		 9890254424

manjula_chavan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed University College of Ayurveda Dhankawadi Pune-43   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients suffering from Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A - janubasti Group B- Agnikarama Control - janubasti   Group A- Janubasti with sahachartail on knee joint for 7 days. Group B- Agnikarama with Tamarashalaka on joint for 7 days (maximum area of tendrness of knee joint) 
Intervention  Group A- Janubasti with sahachar tail Group B- Agnikarama with Tamarashalaka   Group A- Janubasti with sahachartail on knee joint for 7 days. Group B- Agnikarama with Tamarashalaka on joint for 7 days (maximum area of tendrness of knee joint) 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients between age group of 30-70 years.
2. Patients fit for Janubasti and Agni karma.
3. The patients with classical signs & symptoms of Janusandhigata Vata like vedana and sandhi shotha.
4. Patients of radiographic evidence of Osteoarthritis namely reduced space & Osteophytes.

 
 
ExclusionCriteria 
Details  1) patients with Amavata & Vatarakta
2) Janusandhigatavata due to Abhighata.
3) patients with systemic diseases like diabetes And hypertention.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients relive from all Janusandhigata Vata Lakshanas
(signs and Symptoms). In 7 days 		 Access the all signs and symptoms of ostioarthritis with help goniometer(Range of motion) and pain intensity scale. 
 
Secondary Outcome  
Outcome  TimePoints 
Observed all sign and symptoms of janusandhigatavata for a 1 month  Access the all signs and symptoms of ostioarthritis with help goniometer(Range of motion) and pain intensity scale.Result analyses with P value of each Symptoms 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/01/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="5"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Publications in Process 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Brief Summary

Osteoarthritis of knee joint is more prevalent in Indian population, this disease simulates to the sandhigata vata 9Osteoarthriti). It is one of Degenerative Joint Disease characterised by breakdown of joint cartilage. According to WHO Osteoarthritis is the 2nd commonest problem in the world population i.e. 30%. The major risk factors associated with Knee joint are  old age, female , obesity, occupational knee bending & making it an important cause of Disability.  There is no satisfactory, comprehensive & time bound treatment schedule for its management at present. In other treatment has its own limitation in managing this disease. It can provide either conservative or surgical treatment and is highly symptomatic and with troublesome side effects. Whereas such type of conditions can be better treatable by the management and procedures mentioned in Ayurvedic classics. Sandhigata vata (Osteoarthritis) is a major problem as large percentage of population suffers from this disease. Acharya Charaka and Madhav Nidan has explained sandhigata vata (Osteoarthritis) as one among the vata vyadhi (Arthirits) and characterized by vata purna driti sparsha (air filled filling), sandhi vedana(joint Pain) and atopa (crepitus) are the major characteristic features. Acharya Sushrut has explained Snehan (Massage) and Agnikarma (Therapeutic Burn ) for Asthisandhigata vata (Osteoarthritis) . That’s why we are taking this topic for the present study.

 

About Procedure:-

Particular

Group A

Group B

Number Of Patients

50

50

Treatment given

SahacharTail Janubasti (indirect massage Therapy)

Tamarashalaka (Copper Rod)Agnikarama (Therapeutic Burn )

Dose

 

120ml

Binduvat (dot) One seating per day on the maximum tenderness point

Time

After Breakfast

After breakfast

Duration

30 minutes

Till Samyaka dagdha Lakshana(Proper Therapeutic Burn) will be observed.

Purvakarma

(Pre-operative)

Cleaning of janusandhi (knee joint)

Cleaning of janusandhi (knee joint) with hot water

Paschata Karma

(Post-operative)

Remove the steel ring and clean that area with Luke warm

water

Apply the Grita (cow’s Ghee)  on Dagdha (Burn) area

Assessment Day

0, 7th

0, 7th

Follow Up

15th & 30th  Day after Janubasti (indirect Massage)

15th & 30th  day after Agnikarma (Therapeutic Burn)

Pathya-Apathya (diet)

continuous standing & walking will be avoided

continuous  standing & walking will be avoided

 


 
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