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CTRI Number  CTRI/2025/03/082002 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Study to compare the effect of two different local sudation i.e vachadi upanaha in taila as well as vasa (fat)in the management of knee joint pain. 
Scientific Title of Study   A clinical trial to compare the effect of vasayuktha vachadi upanaha with mahanarayana taila yuktha vachadi upanaha in the management of primary OA knee 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amrutha Mohanan 
Designation  MD scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9562827812  
Fax    
Email  amruthamohanan10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Amrutha Mohanan 
Designation  MD scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9562827812  
Fax    
Email  amruthamohanan10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Simi Ravindran 
Designation  Associate Professor HOD 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9496370179  
Fax    
Email  simisreehari@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda college and hospital Thiruvananthapuram 
 
Primary Sponsor  
Name  Dr Amrutha Mohanan 
Address  Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura kerala 695012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Amrutha Mohanan  Government Ayurveda College Panchakarma hospital  Op no 1 Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura kerala 695012
Thiruvananthapuram
KERALA 		 9562827812

amruthamohanan10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda College Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) (Procedure Reference: ashtanga hridaya soothrasthana 17th chapter, Procedure details: vachadi upanaha medicine & mahanarayana taila is applied on affected knee joint after heating. wrapped with leaves & then cloth. kept for 12 hours & removed using lukewarm water)
2Intervention ArmProcedure-upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) (Procedure Reference: ashtanga hridaya soothrasthana 17th chapter, Procedure details: vachadi upanaha medicine & vasa is applied on affected knee joint after heating. wrapped with leaves & then cloth. kept for 12 hours & removed using lukewarm water)
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants irrespective of gender among age group 45-65years of age
2.Radiological changes as per grade 1 to 3 of kellgren-Lawrence radiological scale
3.Participants willing to give informed consent 
 
ExclusionCriteria 
Details  1 Known case of RA and other type of arthritis.
2 Congenital abnormalities
3 Participants with h/o any trauma fractured joint surgical diagnostic intervention with
reference to the affected joint
4 Participants with uncontrolled diabetes mellitus FBS 160mg/dl and
Hypertension,160/100mmhg severe liver and renal disorder Malignancy
5 Known case of dermatological disorders
6 Body mass index BMI40kg/m2 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TUG T test
WOMAC osteoarthritis index
Range of movements using goniometry
safety by event evaluation scale 		 Intervention done for 14 days
Assessment will be done on 0th day,15th day,28th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   11/03/2025 
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 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  
Osteoarthritis(OA) is by far the most common form of arthritis which shows a strong association with
ageing & is a major cause of pain & disability in the elderly. It is the most frequent joint disease
with a prevalance of 22% to 39% in India. As per Ayurveda OA knee is considered as Janu
Sandhigata vata which is a type of VataVyadhi affecting the Sandhi. Pathologically,it maybe defined
as a condition of synovial joints characterized by focal loss of articular hyaline cartilage with
proliferation of new bone& remodelling of joint contour. Swedana is the prime modality of treatment
for many diseases especially Vata &Kapha predominant diseases. Sthambhagna, Gouravaghna
,Sheetaghna are the main properties of Swedana. . Charaka has included Swedana karma under
Shadupakrama,where it is described as a principal method of treatment. Since degenerative OA can be
considered as Kevala Vatika associated with majja dhatu kshaya&shleshaka kapha kshaya ;Upanaha
which is an ideal tropical treatment in which Swedana is done by Bandhana is also indicated for
kevala vatika Condition.Even though it is effective with medium like taila ,for reducing pain only,by
looking forward for Majja dhatu &shleshaka kaphakshaya in Janusandhigata vata we can think about
usage of Vasa as a medium of application in Upanaha which is not studied yet properly.Hence,the
objectives of this study is to find the effect of Vachadi Upanaha with vasa in comparison with taila in
the Management of OA Knee. Vasa ,one among the important Chatusneha dravya ,which is not
commonly used as that of Taila &Ghritha is used here to compare Efficacy. The study is comparative
clinical trial with control group.Cases will be diagnosed based on the Kellagran-Lawrence radiological
scale of OA knee&also data is collected via observation,clinical case performa and xray. Participants
irrespective of sex, aged 45 – 65 years registered in OPD and IPD of Government Ayurveda college
Panchakarma Hospital, Thiruvananthapuram satisfying the inclusion criteria will be subjected to
consecutive sampling and the total of 30 participants will be selected for the study,where the trial
group will receive vachadi Upanaha with vasa and control group will receive the same with
Mahanarayana Taila.
Key words:Osteoarthritis, Upanaha,Vasa. Mahanarayana taila
 
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