| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M771||Lateral epicondylitis. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Autologous whole blood injection | 2ml 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 | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (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)
| | 3 | Comparator Arm (Non Ayurveda) | | - | Local infiltration of Steroid | 1ml 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. |
|
|
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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
- 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 journals
- 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.
- 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 Humerus. Every 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
|