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CTRI Number  CTRI/2024/05/067894 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 21/05/2024
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   Agnikarma and medicines in the pain management of knee osteoarthritis 
Scientific Title of Study   To Evaluate the Efficacy of Add on Treatment of Oral Drug Formulation with Agnikarma in the Management of Jaanu Sandhigata Vata W.S.R. to Osteoarthritis of Knee Joint - A Randomized Controlled Trial. 
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 Asha H Ballari 
Designation  PG Scholar 
Affiliation  SVM Ayurvedic Medical College, ILKAL 
Address  Room number 12 Department of Shalyatantra SVM Ayurvedic Medical College ILKAL

Bagalkot
KARNATAKA
587125
India 
Phone  6363693556  
Fax    
Email  smilea347@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asma 
Designation  Associate Professor 
Affiliation  SVM Ayurvedic Medical College, ILKAL 
Address  Room number 12 Department of Shalyatantra SVM Ayurvedic Medical College ILKAL

Bagalkot
KARNATAKA
587125
India 
Phone  9916028539  
Fax    
Email  dr.asma.hz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Asma 
Designation  Associate Professor 
Affiliation  SVM Ayurvedic Medical College, ILKAL 
Address  Room number 12 Department of Shalyatantra SVM Ayurvedic Medical College ILKAL

Bagalkot
KARNATAKA
587125
India 
Phone  9916028539  
Fax    
Email  dr.asma.hz@gmail.com  
 
Source of Monetary or Material Support  
CCRAS, PG - STAR CCRAS, Ministry of AYUSH, Govt. of India, New Delhi-110058 
 
Primary Sponsor  
Name  CCRAS, PG - STAR 
Address  CCRAS, Ministry of AYUSH, Govt. of India, New Delhi-110058 
Type of Sponsor  Government funding agency 
 
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 
Dr Asma  SVM Ayurvedic Medical College, ILKAL  RPK Ayurvedic Hospital, Opd No. 12, Department of Shalya Tantra
Bagalkot
KARNATAKA 		 9916028539

dr.asma.hz@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,SVM Ayurvedic Medical College, ILKAL  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-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Samhita, Procedure details: PurvaKarma • Patient advised to take Pichhila anna before procedure. • Patient will be taken in supine position, maximum tenderness will be located at the knee joint. Pradhana Karma • With the help of red hot Panchaloha Shalaka, Samyak Bindu Dagdha’s will be made at the maximum tender point & knee joint. Paschat Karma:- • Application Madhu and Ghrita at the site of Agnikarma. • Patient will be advised to avoid water contact for 24 hours.)
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Samhita, Procedure details: Procedure details: PurvaKarma • Patient advised to take Pichhila anna before procedure. • Patient will be taken in supine position, maximum tenderness will be located at the knee joint. Pradhana Karma • With the help of red hot Panchaloha Shalaka, Samyak Bindu Dagdha’s will be made at the maximum tender point & knee joint. Paschat Karma:- • Application Madhu & Ghrita at the site of Agnikarma . • Patient will be advised to avoid water contact for 24 hours.)
(1) Medicine Name: Oral Drug Formulation, Reference: Text-Book-of-Dravyaguna-Vijnana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 12 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Diagnosed cases of Jaanu Sandhigata vata (Osteoarthritisof knee joint) will be selected irrespective of gender, Socioeconomic status, Religion and Occupation.
2.Jaanu Sandhigata Vata (Osteoarthritis of knee joint- Unilateral or bilateral).
3. Kellgren and Lawrence Classification System of Osteoarthritis (Grade 0,1,2,3). 
 
ExclusionCriteria 
Details  1. The patients of infective, neoplastic and Traumatic injuries of knee joint.
2. Patients who have received intra articular corticosteroids,Post surgical and Obese individuals.
3. Patients suffering from Hypertension, Diabetes Mellitus, Rheumatoid Arthritis, Systemic Lupus Erythmatous and Other Systemic disorders.
4. Pregnant and Lactating women.
5. Patients who are contra indicated for Agnikarma.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain, assessed by VAS  0, 7th, 14th, 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
• Tenderness
• Swelling
• Crepitus
• Range of movement by Goniometer
• Kellgren and Lawrence classification system of Osteoarthritis.
 		 0, 7th, 14th, 21st day 
 
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 3 
Date of First Enrollment (India)   12/06/2024 
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="0"
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  

Vitiated vata get settled in sandi Pradesh and aging Dhatus undergo Kshaya (degeneration), thus leading to Sandhivata 1.

Sandhigatavata  is  a  madhyamamargagataroga  and  it  happens  due  to  the  lodging  of  vayu  in sandhi   pradesha, formation   of   oedema   along withthere  is  difficulty  in flexion  and  extension  of  the joints. It is the most common articular disorder which begins asymptomatically in the 2nd and 3rd decades25% females and 16% males have symptomatic OA. Till the age of 55, it occurs equally in both sexes; after 55,the incidence is higher in women2.

   Osteoarthritis is the most prevalent form of arthritis, and the societal burden is expected to increase with the increasing prevalence of obesity and the ageing of the community. There is no cure, and current therapeutic strategies are primarily aimed at reducing pain and improving joint function3.

        For the management of OA, patients need to take analgesics and regular use of analgesics and steroids in old age may produce adverse effects4.Surgical therapy-like knee joint replacement and even after surgery patient has to continue some medicine for a long duration.

Ayurvedic approach of Agnikarma is to relieve the pain in OA, which is a nonpharmacological treatment and it has definite role in Jaanu Sandhigata Vata. .Sushruta has given direction for treatment of the Sandhigata Vata by Agnikarma5. Our clinical stratergy evolved from simple exploratory evalauations in herbal formulation of Guduchi(TinosporaCardifolia), Shunthi ( ZinziberOfficinalae ),Amalaki  ( EmbelicaOfficinalae ),Shallaki  ( Boswelia Serrata )

 in powdered form .

To overcome such limitations of modern management, the present study is effective, safe, simple and economic treatment in the management of janusandigatavata. Hence “TO EVALUATE THE EFFICACY OF ADD ON TREATMENT OF ORAL DRUG FORMULATION WITH AGNIKARMA IN THE MANAGEMENT OF JAANU SANDHIGATA VATA W.S.R TO OSTEOARTHRITIS OF KNEE JOINT – A RANDOMIZED CONTROLLED TRIAL” is taken. 
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