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CTRI Number  CTRI/2024/05/067528 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 17/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative clinical study on ayurvedic and modern therapies in the management of tennis elbow 
Scientific Title of Study   A comparative clinical trial on agnikarma, autologous whole blood injection and local infiltration of steroid in tennis elbow  
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 Poonam Garg 
Designation  Pg scholar 
Affiliation  National Institute of Ayurveda ,Amer road,Jaipur,Rajasthan 
Address  Department of shalya tantra,National Institute of Ayurveda ,amer road,jaipur rajasthan hospital opd no.32

Jaipur
RAJASTHAN
302002
India 
Phone  09893764301  
Fax    
Email  poonamgarg007123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manorma Singh 
Designation  Assistant Professor department of Shalya Tantra 
Affiliation  National Institute of Ayurveda ,Amer road,Jaipur,Rajasthan 
Address  National Institute of Ayurveda , near Jorawar Singh gate,Amer road Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  7414810997  
Fax    
Email  docmanorma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manorma Singh 
Designation  Assistant Professor department of Shalya Tantra 
Affiliation  National Institute of Ayurveda ,Amer road,Jaipur,Rajasthan 
Address  National Institute of Ayurveda , near Jorawar Singh gate,Amer road Jaipur, Rajasthan

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 
 
Primary Sponsor  
Name  National Institute of Ayurveda,Amer road,Jaipur,Rajasthan 
Address  National Institute of Ayurveda ,Amer road Jaipur (rajasthan),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 Poonam Garg  National Institute of Ayurveda  Opd No. 32,Asthi-sandhi unit,National Institute of Ayurveda,Amer road,Jaipur,Rajasthan
Jaipur
RAJASTHAN 
9893764301

poonamgarg007123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee,National Institute of Ayurveda ,deemed to be university(De-Novo) Jorawar singh gate ,Amer road Jaipur,Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M771||Lateral epicondylitis. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Autologous whole blood injection2ml of whole blood will be taken from antecubital vein of other side under full aseptic precautions, It will be injected immediately into the marked site using a peppering technique after replacing the needle with a fresh 22G sterilized needle,patient will be prescribed Tab Levofloxacin 500mg OD for 3 days orally as a post-operatively, Procedure will be done in a single sitting
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: sushruta samhinta sutra sthana 12, Procedure details: Bindu type of Agnikarma will be done in a circular pattern using electric cautery till Samyak Twaka Dagdha Lakshanas are visible followed by application of Ghritkumari and mixture of Madhu and Sarpi,Procedure will be given for three sittings at weekly interval)
3Comparator Arm (Non Ayurveda)-Local infiltration of Steroid1ml of Steroid (Triamcinolone acetonide 40mg) mix with 1 ml of 2 % lignocaine will be injected in most tender point under full aseptic precautions,patient will be prescribed Tab Levofloxacin 500mg OD for 3 days orally as a post-operatively.Procedure will be done in single sitting.
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of age 25-60 year of either gender
Patients presenting with the clinical features of Tennis Elbow
Positive Cozen’s test
Positive Mill’s maneuver test
Positive Maudsley’s test
Ability to respond the questionnaire independently
 
 
ExclusionCriteria 
Details  Patients having open surgical procedure of Tennis Elbow
Recent fracture of Radial head, traumatic or post traumatic pain, head injury, spine injury
Patient having introsseosus nerve syndrome, radial tunnel syndrome
Patient having anatomical defect and congenital structural defect of elbow joint
Patients having joint disorders (viz. RA, OA, Gout).
Patient having systemic ailments like anaemia, uncontrolled diabetes mellitus, uncontrolled hypertension and features of peripheral neuropathy etc.
Patients on long term steroids for any disease.
Insane, mentally instable, unconscious or semiconscious patients.
Patients who required specific treatment for some surgical disease.
Patients with history of ongoing malignancy, chemotherapy or Radiotherapy.
Presence of any local infection, sinuses or skin disease on the proposed site of intervention.
with peripheral vascular disease or peripheral neuropathy.
Post Polio Paralysis or Cerebral Palsy on the affected limb
Contraindications of Agnikarma in group A (Su.Su.12/14)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the PRTEE (Patient Rated Tennis Elbow Evaluation) Scale.
Changes in VAS score.
Improvement in the signs and symptoms of Tennis Elbow.
 
12 Months
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the quality of life of the patients  18 Months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   27/05/2024 
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="6"
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 journals

  6. For how long will this data be available start date provided 30-01-2026 and end date provided 30-01-2031?
    Response - Immediately following publication. No end date.

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

Tennis elbow also known as lateral epicondylitis of the humerus, is a common ailment that causes pain and tenderness on pressure over a very localized spot on the lateral side of the elbow joint, immediately below the epicondyle.It causes restricted movements of the forearm due to strain of the common extensor tendon from the lateral epicondyle of the HumerusEvery year, 1-3% of adults mainly those aged from 35 to 55 years, with an equal gender distribution, are thought to develop tennis elbow, which is more likely in the dominant arm .It is typically regarded as an overuse injury involving repeated wrist extension against resistance, although it can occur from a series of minor pronation and supination strains.As the term Tennis Elbow suggests, up to 50% all tennis players experience this symptom due to various reasons. It is also seen in labourers who use heavy tools or are engaged in repetitive gripping or lifting tasks.The tennis Elbow is also known by other names like Tendonosis, Lateral Epicondylitis and Angiofibroblastic Hyperplasia. An area of degenerative alteration or non-specific inflammation at the site of origin of extensor tendons appears to be the underlying pathophysiology of Tennis Elbow. When the forearm is semi-pronated, the muscles are tensed, if rapid activity was performed, a sudden flexion of the wrist pulls the forearm’s extensor muscle at its epicondylar attachments, which results in damage and cause Lateral epicondylitis.Amongst the extensor tendons taking origin in the region of the lateral epicondyle, the extensor carpi radialis brevis has often been implicated as the key structure in Tennis Elbow. Its unusual anatomy exposes it to shearing forces in almost all movements of the arm.

 In Ayurveda literature, the diseases of ligaments and tendons were mentioned in SnayugataVikara.  Snayugatavata means vitiated Vata Dosha causes various diseases taking Snayu as Adhisthana. Acharya Sushruta has explained various modalities to manage Snayu, Sandhi Vikara and it includes Snehana, Upanaha, Agnikarma and Bandhana.

Current epidemiological status and morbidity associated with tennis elbow necessitates its safe, effective and economic management.There is a need to explore the most effective management modality among the various interventions used to manage it in Ayurveda and contemporary system of medicine


 
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