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CTRI Number  CTRI/2022/08/044949 [Registered on: 26/08/2022] Trial Registered Prospectively
Last Modified On: 23/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To understand the Effect of Karpura, Rason and Yavani(KRY) Taila in vedana and shotha of Sandhigatavata. 
Scientific Title of Study   A clinical study to evaluate Vedana and Shothahar Karma of Karpura, Rason and Yavani(KRY) Taila in Sandhigatavata. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suresh Chaubey 
Designation  Professor 
Affiliation  Rishikul Campus Haridwar Uttarakhand Ayurved University  
Address  P.G. Department of Dravyaguna Rishikul Campus Haridwar Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  9452811909  
Fax    
Email  sureshdr235@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Chaubey 
Designation  Professor 
Affiliation  Rishikul Campus Haridwar Uttarakhand Ayurved University  
Address  P.G. Department of Dravyaguna Rishikul Campus Haridwar Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  9452811909  
Fax    
Email  sureshdr235@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Partibha Singh 
Designation  MD Scholar  
Affiliation  Rishikul Campus Haridwar Uttarakhand Ayurved University  
Address  P.G. Department of Dravyaguna Rishikul Campus Haridwar Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
247670
India 
Phone  9675394313  
Fax    
Email  rana.313pratibha@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus,UAU Haridwar 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University  
Address  P.G DEPARTMENT OF DRAVYAGUNA RISHIKUL CAMPUS UTTARAKHAND AYURVED UNIVERSITY HARIDWAR 249401  
Type of Sponsor  Government medical college 
 
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 
PARTIBHA SINGH  ROOM NUMBER -1 OPD & IPD OF KAYACHIKITSA DEPARTMENT RISHIKUL CAMPUS  Rishikul Campus Uttarakhand Ayurved University Haridwar 249401
Hardwar
UTTARANCHAL 		 9675394313

rana.313pratibha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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: SANDHIGATAVATA , (2) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATA ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: charak chikitsa 28/181, Procedure details: Gentle application of Panchaguna Taila twice a day in an appropriate amount according to the surface area for a period of 21 days)
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: charak chikitsa 28/181, Procedure details: Gentle application of KRY Taila twice a day in an appropriate amount according to the surface area for a period of 21 days))
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Patient having clinical features of
Osteoarthritis (Knee joint).
2)Patient between the 40 - 70 year of age
irrespective of gender.
3) Pain of mild to moderate range.
4) Cases of primary knee osteoarthritis only.
5) Patient without any anatomical deformity. 
 
ExclusionCriteria 
Details  1) Patient below the 40 and above the 70 year of
age.
2) Severe range of pain.
3) Patient with secondary knee osteoarthritis.
4) Patients having past history of RA, Gout,
Psoriasis etc.
5) Patient suffering from any serious medical or
surgical illness.
6) Pain due to accidental open wound injury.
7) Patient not willing to undergo trial.
8) Associated with any local fracture and fracture
associated osteopathy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Decrease in pain intensity
2) Tenderness
3) Stiffness &
4) Crepitus in both knee joint  		 3 assessment at an interval of 7 days followed by follow up period of 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1)Reduction in swelling 2)Increased in range of motion of both knee joint
3) Walking time to cover 40
feet in seconds
4) WOMAC scale  		 3 assessments at an interval of 7 days followed by follow up period of 7 days 
 
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   Phase 2 
Date of First Enrollment (India)   29/08/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In Ayurvedic texts various terms such as, Ruk, Ruja, Vedana and Shool are commonly used for pain. As the word Vedana has been used in two sense in Ayurveda i.e. Sukhatamaka Vedana (feeling of happiness) and Dukhatamaka Vedana (feeling of unhappiness).Acharaya Charaka has mentioned the word ‘Vedana’ is very wide which include both the healthy and diseased conditions.In Ayurveda, Vedana word has been used in the sense of perception, knowledge, feeling and pain. So all types of pain come in the purview of Vedana, which are the challenges for a physician in clinic practices.Vitiated Vata Dosha has predominant role in manifestation of Vedana and Shotha, which are most common symptom in majority of diseases and Sandhigatavata (Osteoarthritis) is one of them. Acharya Charaka considered Vatavyadhi as Maharoga. Sandhigatavata is described under the Vatavyadhies in all Samhita and Sangrahagrantha. Sandhigatavata is characterized by symptoms like Sandhishool(joint pain), Shotha(swelling), Prasaranaakunchanyopravaruttischavedana(painfull joint movement). It can be correlated to Osteoarthritis. Clinically it is represented as pain in joints, stiffness, tenderness, crepitus and restricted joint movements. Radiologically osteoarthritis is characterized by narrowing of joint space, osteophytic changes and deformity in joints.                           

Osteoarthritis is the second most common rheumatological problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. OA is more common in women than men, but the prevalence increases dramatically with age. Nearly, 45% of women over the age of 65 years have symptoms while radiological evidence is found in 70% of those over 65 years.

As mentioned in Charaka Chikitsa Vatavyadhiadhyay, Taila is the best treatment of Vata Dosha. Hence this Taila is selected here for breaking of Samprapti of Sandhigatavata.

 
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