| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - data will be available only if published in peer reviewed journal.
- 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.
- 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. |