| CTRI Number |
CTRI/2026/03/105298 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the effect of Marma Chikitsa and Ultrasound Therapy in Tennis Elbow |
|
Scientific Title of Study
|
A Randomized Clinical Study to Evaluate the Efficacy of Marma Chikitsa and Ultrasound Therapy in the Management of 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 Nidhiranjan Singh |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Marmalogy and Sports Medicine
National Institute of Ayurveda
Jaipur Rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
9400946776 |
| Fax |
|
| Email |
nidhiranjan37@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr P Hemantha Kumar |
| Designation |
Pro VC and HOD |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Marmalogy and Sports Medicine
National Institute of Ayurveda
Jaipur Rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr P Hemantha Kumar |
| Designation |
Pro VC and HOD |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Marmalogy and Sports Medicine
National Institute of Ayurveda
Jaipur Rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
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 Nidhiranjan Singh |
National Institute of Ayurveda Hospital |
OPD no 8 Sushruta Bhawan Department of Marmalogy and Sports Medicine
Academic Block first floor
National Institute of Ayurveda Jaipur Rajasthan Jaipur RAJASTHAN |
9400946776
nidhiranjan37@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:M771||Lateral epicondylitis. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: -, Procedure details: o Each Marma point is stimulated in synchrony with the rhythm of respiration, typically amounting to approximately 18 cycles.
o The Marma points are stimulated by gentle pressing & releasing, repeated approximately 15–20 times per session.
o The treatment is administered once daily for a total of 15 days.
)
| | 2 | Intervention Arm | Procedure | - | Ultrasound Therapy | (Procedure Reference: -, Procedure details: 10 minutes once in a day for 15 days)
| | 3 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा and Ultrasound therapy | (Procedure Reference: -, Procedure details: combination of Marma Chikitsa & Ultrasound Therapy will be done once daily for 15 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient of age 25 - 60 year of either gender.
2 Patients presenting with the clinical features of Tennis Elbow.
3 Positive Cozen’s test.
4 Positive Mill’s maneuver test.
5 Ability to respond the questionnaire independently. |
|
| ExclusionCriteria |
| Details |
1 Patients having open surgical procedure of Tennis Elbow.
2 Recent fracture of Radial head.
3 Patient having anatomical defect and congenital structural defect of elbow joint
4 Patients having degenerative joint disorders
5 Patients on long term steroids for any disease.
6 Insane, mentally unstable, unconscious or semiconscious patients.
7 Presence of any local infection, sinuses or skin disease on the proposed site of intervention.
8 Patients with diagnosed case of peripheral vascular disease or peripheral neuropathy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the PRTEE (Patient Rated Tennis Elbow Evaluation) Scale |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in VAS score, Radiation of Pain & Soft Tissue Tenderness Grading Scale
Comparison of the effect of both treatment modalities for management of Tennis Elbow |
15 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| 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="0" 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
- 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 - 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nidhiranjan37@gmail.com].
- For how long will this data be available start date provided 31-10-2026 and end date provided 31-10-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
o Tennis Elbow (Lateral Epicondylitis) is commonly treated with conservative methods, but current treatments show inconsistent effectiveness in pain relief and functional recovery. o Marma Chikitsa is an Ayurvedic, non invasive therapy focused on stimulating vital energy points, promoting Prana flow, and restoring Dosha balance, but lacks robust scientific evidence for its efficacy in tennis elbow. o Ultrasound therapy uses high frequency sound waves to enhance tissue healing and reduce pain but has shown variable results across studies. o There is a need to compare these two approaches to evaluate their relative effectiveness, determine complementary benefits, and explore their potential as part of an integrative treatment strategy for tennis elbow. o A head to head comparison will provide insight into the mechanisms, safety, and clinical outcomes of both therapies, supporting the development of more evidence based treatment protocols for tennis elbow management. |