| CTRI Number |
CTRI/2026/02/104208 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study on Leech Therapy and Paraffin Wax Therapy for the Treatment of Tennis Elbow. |
|
Scientific Title of Study
|
A Randomized Comparative clinical trial to evaluate the efficacy between Jalaukavacharana and Paraffin wax 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 Nitin Mhatu Pokale |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College Of Ayurved and Research Centre,Nigd,Pune |
| Address |
PDEAs College of Ayurved and Research Centre Third floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune Pune MAHARASHTRA 411044 India
PDEAs College of Ayurved and Research Centre Third floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune Pune MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9130311339 |
| Fax |
|
| Email |
nitinpokale2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College Of Ayurved and Research Centre,Nigd,Pune |
| Address |
PDEAs College of Ayurved and Research Centre Third floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune Pune MAHARASHTRA 411044 India
PDEAs College of Ayurved and Research Centre Third floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune Pune MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College Of Ayurved and Research Centre,Nigd,Pune |
| Address |
PDEAs College of Ayurved and Research Centre Third floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune Pune MAHARASHTRA 411044 India
PDEAs College of Ayurved and Research Centre Third floor Shalyatantra department Sector no 25 Pradhikaran Nigdi Pune Pune MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research centre ,nigdi pune maharastra 411004 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
PDEAs College of Ayurved and Research Centre third floor shalyatantra department sector 25 Pradhikaran Nigadi Pune Maharashtra India 411044 |
| Type of Sponsor |
Private 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 Nitin Mhatu Pokale |
Ayurved Rugnalaya and Snowbell Multispeciatlity hospital, Nigdi |
Ayurved Rugnalaya and Snowbell Multispeciatlity
hospital,Shalyatantra Dept OPD No.123A pradhikaran
sector No.27 Nigdi, Pune
Pune MAHARASHTRA
Pune
MAHARASHTRA |
09130311339
nitinpokale2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushruta chikitsasthana 4/7,Sharangadhara Uttara Khanda,12/17, Procedure details: Lateral epicondyle cleaned with sterile gauze (aseptic precautions).
Leech held by hand & mouth placed on tender point.
Allowed to suck blood for 30–45 minutes.
Detached spontaneously; if not, turmeric paste applied for removal.
Procedure done on Day 1 & repeated on Day 7.
Assessment carried out on Day 14.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | PARAFFIN WAX THERAPY | Patient instructed to sit comfortably with elbow supported.
Wax melted to 45–50 °C.
Applied over lateral epicondyle with spatula in 3 coats.
Wax-coated area covered and wrapped with towel to retain heat.
Kept in place for 15–20 minutes.
Therapy given from Day 1 to Day 7.
Assessment carried out on Day 14. |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
clinically diagnosed case of tennis elbow have two of the following symptoms
pain on lateral epicondyle
positive cozens test /mills test
tenderness
stambha(stambha) |
|
| ExclusionCriteria |
| Details |
known case of
1)Uncontrolled Diabetes mellitus
2)Bleeding disorders
3)Patients on anticoagulant therapy
Anemia
History of Elbow fracture or dislocation, or surgery of the Elbow joint |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect between Jalaukavacharang and Paraffin Wax Therapy in the management of Tennis Elbow over 14 days, based on reduction in pain & improvement in function. |
To compare the effect between Jalaukavacharang and Paraffin Wax Therapy in the management of Tennis Elbow over 14 days, based on reduction in pain & improvement in function. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To record and monitor adverse events or complications associated with Jalaukavacharana and Paraffin Wax Bath Therapy over 14 days, if any. |
Follow up on the 7th day & Assessment on the 14th day of treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/03/2026 |
| 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="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 - NO
|
|
Brief Summary
|
This dissertation synopsis presents a randomized comparative clinical trial evaluating the efficacy of Jalaukavacharana (leech therapy) versus Paraffin Wax Therapy in managing Tennis Elbow (lateral epicondylitis), an overuse disorder of the forearm extensor tendons causing lateral elbow pain, tenderness, and functional limitation. Sixty patients will be randomly divided into two groups—one receiving Jalaukavacharana on Day 1 and 7, and the other Paraffin Wax Therapy from Day 1 to 7—with assessment on Day 14 using pain scale, tenderness grading, Cozen’s and Mill’s tests, and stiffness evaluation. Jalaukavacharana, an Ayurvedic blood-letting procedure, helps reduce inflammation and pain, while Paraffin Wax Therapy provides therapeutic heat to relieve pain and improve joint mobility; statistical analysis will determine the comparative effectiveness and safety of both treatments. |