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CTRI Number  CTRI/2024/02/063103 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 05/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Panchakarma in Knee joint pain 
Scientific Title of Study   Efficacy of Rasnadi Ghrita Anuvasana Basti in the Management of Janu Sandhigata Vata W.S.R to Knee Osteoarthritis – A Randomised Controlled Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Not Applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayathri B 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9003329656  
Fax    
Email  gayathribaskaran97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajashekhar V Sanapeti 
Designation  Professor and HoD 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajashekhar V Sanapeti 
Designation  Professor and HoD 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi


KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
 
Primary Sponsor  
Name  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not Appplicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gayathri B  KLE Ayurveda Hospital and Medical Research Centre  Room No 04 and IPD Department of Panchakarma KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi 590003
Belgaum
KARNATAKA 
9003329656

gayathribaskaran97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi  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-bastikarma, बस्तिकर्म (Procedure Reference: Caraka Samhita, Procedure details: Anuvasana basti with Guggulu tiktaka ghrita 75 ml through rectal route for 11 days)
2Intervention ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: Caraka Samhita, Procedure details: Anuvasana basti with Rasnadi ghrita 75 ml through rectal route for 11 days)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient having symptoms of Janu sandhivata (OA of knee joint) such as pain,swelling ,stiffness or crepitus.
Patient having x-ray based on grade (grade 1 to grade 3) of knee osteoarthritis will be taken
Patient of age group between 30 to 70
Patient of either sex will be included .
 
 
ExclusionCriteria 
Details  Patients of rheumatoid arthritis ,ankylosing and traumatic arthritis
Patients suffering from paralysis
Patients having septic arthritis ,tuberculosis ,brucellosis,pyogenic osteomyelitis
Patients having neoplasm of spine
Patients with bony deformity
Patients with uncontrolled diabetes and hypertension.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain, VAS Scale, Womac Scale, Whoqlbref Scale,   0th and 11th day 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/03/2024 
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="2"
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  

Osteoarthritis (OA) is the most common type of arthritis and is a major cause of pain and disability in older people[1].  Epidemiological studies have reported that Arthritis uncommon  among adults <40 and highly prevalent of those aged >60[2] and older, and report says that 22% to 39% have been diagnosed with osteoarthritis. Osteoarthritis is prevalent more in females than males, and report says that 45% of women above 65 years have osteoarthritis pain and 70% have been diagnosed with radiological findings[2].

Ageing is associated with multiple condition of medicine due to deteriorating physiological actions and impaired metabolic mechanisms. Epidemiological ageing studies report that non-communicable diseases such as diabetes, arthritis etc., are integral part of ageing[2]. There is higher risk of dependency due to psychological stress.Repetive adverse loading of joints during occupation or competitive sports ,obesity are also important predisposing factor[3].

Osteoarthritis is a chronic condition and the main goals of the treatment  are to alleviate pain and minimalize loss of physical function.[2]

The approach to the management of symptomatic osteoarthritis (OA) in the geriatric population differs from the approach in younger patients because of the substantial toxicity of nonsteroidal anti-inflammatory drugs (NSAIDs) in older patients.[2]

Non-pharmacological interventions should be the first line of treatment[2].

While some patients older than 65 can tolerate NSAID use with concomitant protection from gastrointestinal (GI) bleeding with a proton pump inhibitor (PPI), this regimen exposes patients to two drugs with numerous potential adverse drug effects.[2] Intra-articular corticosteroid injections are effective in the treatment of knee OA and also used for symptomatic relief in treatment of OA at first CMC joint.[3]   But repeated steroidal injections leads to more cartilage damage .[4]

Evidence base of anti-neuropathic drugs is also poor. Presently there are no licensed drugs that can prevent, stop or restrain the progression of OA in modern medicine. Even up to 30% of individuals continue to experience pain and disability after total knee joint replacement surgery.[3]

In ayurveda, the vitiated vata combines with dosha ,dushya circulates throughout the body and lodges in a particular site and manifests vatavyadhi.[5]

Anuvasana basti is specifically indicated in the persons who are having dryness in the body,excessive appetite and suffering from kevala vata disorders.In these conditions Anuvasana is the first choice.Anuvasana basti can be given directly without prior administration of niruha basti in the patient suffering from excessive aggravation of vata.[5]

Rasnadi ghrta is selected for Anuvasana Basti chikitsa in Janu sandhivata .It contains Rasna, Dasamoola, Shatavari ,kulatha, Badara, Yava, Ajamamsarasa,and jeevaniya gana drugs which possess madhura, tiktha, guru, snigdha qualities which increases the sleshaka kapha and it helps in preventing the degeneration of the joints .This medicine used in the form of pana ,navana,basti in the diseases caused by vata .

 
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