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CTRI Number  CTRI/2024/07/071633 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Agnikarma]  
Study Design  Single Arm Study 
Public Title of Study   To study the effect of Karaskara Ghritam and Agnikarma in the treatment of Knee - Osteo Arthritis 
Scientific Title of Study   A Clinical study on the Efficacy of Karaskara Ghritam (Orally) and Agni Karma (Bindu Akruti) in the management of Janusandhigata Vata W.S.R to Osteo Arthritis - Knee 
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 V Kranthi Kumari 
Designation  Post Graduate Scholar in Kaya Chikitsa  
Affiliation  Dr BRKR Government Ayurvedic Medical College, Erragadda, Hyderabad 
Address  Room No.2, Division No. 2, Kaya Chikitsa-OPD, Dr. BRKR Government Ayurvedic Medical College and Hospital, Erragadda, Hyderabad.

Hyderabad
TELANGANA
500038
India 
Phone  9848884807  
Fax    
Email  kranthibelaganti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Laxmikantham 
Designation  MD (AYU), Professor, Guide 
Affiliation  Dr. BRKR Government Ayurvedic Medical College, Erragadda, Hyderabad 
Address  Room No.2, Division No. 2, Kaya Chikitsa-OPD, Dr. BRKR Government Ayurvedic Medical College and Hospital, Erragadda, Hyderabad.

Hyderabad
TELANGANA
500038
India 
Phone  9989398463  
Fax    
Email  drlaxmikantham20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Laxmikantham 
Designation  MD (AYU), Professor, Guide 
Affiliation  Dr BRKR Government Ayurvedic Medical College, Erragadda, Hyderabad 
Address  Room No.2, Division No. 2, Kaya Chikitsa-OPD, Dr. BRKR Government Ayurvedic Medical College and Hospital, Erragadda, Hyderabad.

Hyderabad
TELANGANA
500038
India 
Phone  9989398463  
Fax    
Email  drlaxmikantham20@gmail.com  
 
Source of Monetary or Material Support  
Dr V Kranthi Kumari, Post Graduate Scholar, Department of Kaya Chikitsa, Dr. BRKR Government Ayurvedic Medical College and Hospital, Erragadda, Hyderabad - 500038.  
 
Primary Sponsor  
Name  Dr V Kranthi Kumari 
Address  Dr. BRKR Government Ayurvedic Medical College and Hospital, Erragadda, Hyderabad. 
Type of Sponsor  Other [Self] 
 
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 V Kranthi Kumari  Dr. BRKR Government Ayurvedic Medical College and Hospital, Hyderabad  Room No.2, Division No. 2, Kaya Chikitsa-OPD, Dr. BRKR Government Ayurvedic Medical College and Hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA 		 9848884807

kranthibelaganti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KNR University of Health Sciences, Warangal, Telangana, India  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 ArmDrugClassical(1) Medicine Name: Karaskara Ghrita, Reference: Sahasrayogam, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: Reference: Sahasrayogam, Parisishta Prakarana Taila, Chapter No. XI, Yoga No. 33
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushrutha Samhita, Procedure details: Procedure of Agnikarma: 1. Pradhana Karma involves Bindu akruti Agni karma with the usage of Panchadhathu Shalaka at the affected part, which is heated upto red hot (tolerable heat). 2. Agni karma will be done at maximum tender sites affected at the knee joint. 3. The minimum space has to be kept between two Agni karma points to avoid overlapping of the Dagdha vrana. 4. After Agni karma, fresh Ghrita kumari pulp will be applied on Dagdha to relieve the burning sensation & pain. Duration of the treatment: 60 Days (8 sessions - once in a week))
(1) Medicine Name: Karaskara Ghrita, Reference: Sahasrayogam, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Duration: 60 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients having symptoms of Janu Sandhigata Vata like Sandhi Shotha, Vatapurna drithi Sparsha, Akunchana Prasarana vedana.
2. Patients with classical signs and symptoms of Sandhigata vata will be selected; irrespective of religion, profession, etc.
3. Patients with clinical features of Osteo Arthritis and radiological findings of Osteo Arthritis in the Knee joints.
4. Radiological changes as per grades 1 to 3 of Kellgren-Lawrence radiological scale of Osteo Arthritis.
5. Patients who are not responding by a single therapy.
6. Patients who are eligible and who give informed consent to undergo Agni karma. 
 
ExclusionCriteria 
Details  1. Sandhigata vata other than Janu sandhigata vata.
2. Patients with other connective tissue disorders and secondary Osteo Arthritis.
3. Patients with congenital, physical deformity of knee joint and any history of trauma.
4. Patients with co-morbidities such as Gouty Arthritis, Rheumatoid Arthritis, Psoriatic Arthritis, etc.
5. Patients who are currently participating in any other Clinical trials.
6. Meniscal tear and ligament injury.
7. Patients with uncontrolled Diabetes.
8. Patients with Obesity (BMI >30), HIV, HbsAg, uncontrolled Hypertension, Hyperlipidemia, Cancer, Left Ventricular Hypertrophy, Ishchaemic Heart Disease, Tuberculosis and other systemic disorders which may lead to fatal condition.
9. Pregnant women and Lactating mothers.
10. Post Knee Replacement surgery.
11. 4th grade of Kellgren – Lawrence grading Scale Classification.
12. Patients who are contraindicated to undergo Agni karma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To provide relief from the clinical features of Janusandhigata Vata - Osteo Arthritis Knee.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
To restore the normal Range of Motions.  60 days 
 
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   N/A 
Date of First Enrollment (India)   16/08/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kranthibelaganti@gmail.com].

  6. For how long will this data be available start date provided 16-07-2024 and end date provided 15-09-2025?
    Response - Immediately following publication. No end date.

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

v  Janu Sandhigata vata is the most common form of the Sandhi (joint) disorders. It is commonly known as degenerative joint disease or “wear and tear” arthritis. It occurs most frequently in the knees, hips and hands.

v With Osteo Arthritis, the cartilage within a joint begins to break down and the underlying bone begins to change. These changes usually develop slowly and get worsen over a period of time. Osteo Arthritis can cause pain, stiffness and swelling. In some cases, it also causes reduced function and disability; some people are no longer able to attend their daily tasks or work.

v  In the present era, human beings are prone to early degenerative diseases, because of stressful and sedentary life style habits.

v  According to WHO, Osteo Arthritis is the second commonest musculoskeletal problem in the world population.

v  The following are the risk factors of Osteo Arthritis :

Ø  Joint injury or overuse – Injury or overuse, such as knee bending and repetitive stress on a joint, can damage a joint and increase the risk of Osteo Arthritis in that joint.

Ø  Age – The risk of developing Osteo Arthritis increases with age.

Ø Gender – Women are more likely to develop Osteo Arthritis than men, especially after the age of 50.

Ø Obesity – Extra weight puts more stress on joints, particularly weight-bearing joints like the knees and hips. This stress increases the risk of Osteo Arthritis in that joint. Obesity may also have metabolic effects that increase the risk of Osteo Arthritis.

Ø Genetics – People who have family members with Osteo Arthritis are more likely to develop Osteo Arthritis. People who have hand Osteo Arthritis are more likely to develop knee Osteo Arthritis.

Ø  Race – Some Asian populations have lower risk for Osteo Arthritis.

v  Osteo Arthritis was the 20th most common cause of Years Lived with Disabilities in India in 2019, accounting for 1.48% of all Years Lived with Disabilities; increasing from 23rd most common cause in 1990 (1.25%).

v  Over the last three decades, the prevalent symptomatic Osteo Arthritis cases in India increased 2.66-fold from 23.46 million in 1990 to 62.35 million in 2019.

v  Total Disability Adjusted Life Years due to Osteo Arthritis increased by more than 2.69-fold, from 0.79 million (95%) UI: 0.40–1.55) in 1990 to 2.12 million (95% UI: 1.07–4.23) in 2019.

v  The prevalence, incidence, and Disability Adjusted Life Years for Knee Osteo Arthritis are consistently higher in females than males.

v  In the present era, human beings are prone to early degenerative diseases, because of stressful and sedentary life style habits.

v  A number of drugs which are effective in relieving symptoms are available in contemporary sciences. But, in due course these drugs can cause adverse effects when used for a long time, causing an additional trouble for the patients.

v  Keeping this in view, it is needed to focus on drugs which are of herbal sources and cost effective.

v  Hence, the drug selected for this study in Janu Sandhigata vata is Karaskara Ghrita. The drug possess Vata Pitta Shamaka, Vedana Sthapana, Anulomana, Shothahara, Rasayana, Sula Prashamana properties and the selected procedure – Agnikarma acts on Vata Kapha dosha and alleviates the pain. Pain reduces significantly with minimal recurrence rates.

Considering all the above points, a treatment modality focusing on Ayurvedic approach in the management of Janu Sandhigata vata using the Vatahara drugs has been formulated, which is essential for its effective management in the study. 
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