FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067240 [Registered on: 13/05/2024] Trial Registered Prospectively
Last Modified On: 11/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial on bloodletting therapy in knee osteoarthritis 
Scientific Title of Study   A clinical study to evaluate the effect of siravedha on knee osteoarthritis and pro-inflammatory biomarkers  
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. Bharati Samota 
Designation  Pg scholar  
Affiliation  National institute of Ayurveda , Jaipur 
Address  Department of shalya tantra, National institute of ayurveda, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8005965999  
Fax    
Email  bharatisamota5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suman Sharma 
Designation  Associate professor 
Affiliation  National institute of ayurveda, jaipur 
Address  Department of shalya tantra, National institute of ayurveda, jorawar singh gate, amer road jaipur,302002

Jaipur
RAJASTHAN
302002
India 
Phone  9418159666  
Fax    
Email  sumanhp2006@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manorma Singh 
Designation  Assistant professor 
Affiliation  National institute of ayurveda, jaipur 
Address  Department of shalya tantra, National institute of ayurveda, jorawar singh gate, amer road jaipur, 302002

Jaipur
RAJASTHAN
302002
India 
Phone  7414810997  
Fax    
Email  docmanorma@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Amer road, Jaipur, Rajasthan, India, 302002  
 
Primary Sponsor  
Name  National institute of ayurveda jaipur  
Address  National institute of ayurveda, jorawar singh gate, amer road jaipur, 302002 
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 
Dr Bharati Samota  National institute of ayurveda, jaipur   OPD number-32, National institute of ayurveda hospital jorawar singh gate, amer road jaipur,302002
Jaipur
RAJASTHAN 
08005965999

bharatisamota5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, national institute of ayurveda jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: sushruta samhita sharir sthana 8/8, Procedure details: Total 3 sittings of Siravedha will be done at interval of 10 days. Three follow up visits will be done, first at an interval of 15 days than two follow ups will be done at intervals of 1-1 month . Total duration will be 3 months 6 days The whole procedure of Siravedha will be explained to the patient Vitals will be checked . Written informed consent will be taken . Patient will be advised to take Yvagu prior to the procedure. The patient will be placed in the supine position w)
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Grade 2 knee osteoarthritis patients as per Kellgren and Lawrence classification system 
 
ExclusionCriteria 
Details  Rheumatoid arthritis, Gouty arthritis, osteomyelitis and septic arthritis of knee joints,
local infection or skin diseases on the proposed site of Siravedha,
Patients suffering from cardiovascular diseases, HIV, hepatitis, diabetes mellites, hypertension, Anemia and bleeding disorders.
Contraindications for Siravedha.
History of trauma to knee joint.
History of surgical intervention on knee joint. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in symptoms of knee osteoarthritis.
Change in WOMAC scale.
Change in Pro-inflammatory biomarkers in blood after Siravedha in knee osteoarthritis. 
21days 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of type of the Prakriti most vulnerable to Knee Osteoarthritis.
Change in quality of life of the patient.  
3 months 
 
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 3 
Date of First Enrollment (India)   30/05/2024 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  data will be available only if published in peer reviewed journal.

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Osteoarthritis is a very common joint disease characterized by destruction of joint cartilage. It is produced by mechanical stress over the joint and it manifests as swelling, stiffness and joint pain.  Osteoarthritis of knee is a leading cause of chronic disability in elderly, prevalence of knee osteoarthritis rises with age and is more in females than in males. The knee joint is most complex and largest joint of the body and is most vulnerable to damage because it is a mobile and weight-bearing joint. Knee osteoarthritis is one of most common form of arthritis in synovial joints. Synovial membrane inflammation plays an important role in development of pain, joint inflammation and cartilage destruction. Hence, pro-inflammatory mediators also play an important role in osteoarthritis. Knee osteoarthritis can be co-related with Janu Sandhigatavata because it resembles in sign and symptoms of Sandhigatavata told in Ayurveda literature such as Sandhi Shula and  Shoth  in affected joints. In contemporary science a wide range of treatment modalities are available such as anti-inflammatory, analgesics, calcium and vitamin D supplements, steroids and physiotherapy but have limited prognosis due to side effects after prolonged use. So, there is need of more treatment modalities to manage sign and symptoms of knee osteoarthritis. Ayurveda offers various treatments for Sandhigatavata. There is no lasting treatment available for knee osteoarthritis and Acharya Caraka mentioned that if the disease is not treatable with all the treatment methods explained for that disease, then we should treat it as Raktaj Vyadhi. Acharya Charaka described Raktamokshana in Raktaj Vyadhi. Acharya Sushruta mentioned Siravedha in Vatavedan. Siravedha is an important surgical intervention in shalya tantra, Acharya Sushruta described   alone Siravedha as  Chikitsa-Ardha half treatment   in Shalya Tantra. Ayurveda emphasizes evaluation of patients in totality for perfect diagnosis and management of disease.  Acharya Caraka and Acharya Sushruta recommended extensive guidelines for assessment of disease and diseased. Prakriti assessment is a part of Dashavidha Pariksha. Prakriti is the nature of the body in terms of the Dosha and is decided at the time of conception according to the predominance of Dosha.  Prakriti of patients also plays an important role in deciding treatment modalities. This study is specially planned to see effect of Siravedha on knee osteoarthritis and to see change in inflammatory markers in blood after  Siravedha.  

 
Close