| CTRI Number |
CTRI/2024/05/067309 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Other (Specify) [Mud Therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the analgesic effect of Mud Therapy in Tennis Elbow |
|
Scientific Title of Study
|
A Comparative Clinical Trial to Evaluate the Analgesic Effect of Mud Therapy and Mustadi Upanaha in the Management of Snayugata Vikara with special reference to 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 Sarvesh Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no 228 Department of Swasthvritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No 228 Department of Swasthvritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahab Hussain |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No 201 Department of Swasthvritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9917722775 |
| Fax |
|
| Email |
drshahabhussain26@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
Department of swasthvritta and yoga National Institute of Ayurveda jorawar Singh gate amber road Jaipur Rajasthan |
| 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 Shahab Hussain |
National Institute of Ayurveda |
OPD No 21 Jorawar Singh gate amber road Jaipur Rajasthan
Jaipur
RAJASTHAN |
9917722775
drshahabhussain26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M658||Other synovitis and tenosynovitis. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | upanAha-karma, उपनाह-करà¥à¤® | (Procedure Reference: , Procedure details: mud will be applied on affected elbow once a day in the evening and will be covered with crepe bandage till it dries up )
| | 2 | Comparator Arm | Procedure | - | upanAha-karma, उपनाह-करà¥à¤® | (Procedure Reference: sushrut samhita chikitsa sthana chapter 1 shloka 23 24, Procedure details: Upnaha will be applied locally once in a day at morning for duration of 4 weeks)
(1) Medicine Name: Mustadi Upnaha, Reference: charak chikitsa chapter 28 shloka 113, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years irrespective of gender caste and religion
Patient with typical clinical features pertaining to acute elbow pain and difficulty in holding or gripping the objects
Patient of first and second stage of tennis elbow
First stage Involve Mild tenderness early inflammatory reaction single muscle Most commonly Extensor Carpi Radialis Bravis ECRB involvement
Second stage Mild to moderate tenderness partial tearing of ecrb plus subjacent of the common extensor followed by angiofibroblastic degeneration localized marked swelling
|
|
| ExclusionCriteria |
| Details |
Chronic elbow pain and swelling
Any co morbid condition
Any systemic disease e g Osteoporosis rheumatoid arthritis gout
Third stage tennis elbow ie significant instability complete tear of ecrb possible tenderness medially and laterally completely restricted movement of elbow If pain provoking tests maudsley s test and resistive tennis elbow test cozen s test are positive
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement in pain |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the changes in pain score tenderness and loss of function scales |
Baseline and four weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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 - NO
|
|
Brief Summary
|
NEED OF STUDY
Tennis Elbow is one of the common injury in
tennis players and people who usually do the work which involve the twisting
activity of the forearm.
RICE(Rest,
Ice-packing, Compressions and Elevation), analgesics, anti-inflammatory drugs
are general line of treatment of Tennis Elbow in Modern medical science.[11]
NSAIDs,
corticosteroids and platelet rich plasma therapy are preferred for reducing
pain and inflammation, although these medications posses several side effects.
Due
to the presence of anti-inflammatory principle, Mud therapy is a best
palliative treatment for pain management due to its multiple effect e.g.
relieving muscle spasm and inflammation which has no side effect because it
uses natural way of healing. This treatment can be easily planned, non-invasive
and cost effective[12].
The
clinical trial of mud therapy in tennis elbow is noble one. No study has been
found in this area till date.
Aim
To explore mud therapy treatment modality for Snayu Gata Vata (Tennis
Elbow).
Objective
To evaluate the analgesic effect of mud therapy in Snayu
Gata Vata(Tennis Elbow).
RESEARCH QUESTION
Whether mud therapy has an analgesic effect in the management
of Snayu Gata Vatavikara (Tennis
Elbow)?
NULL HYPOTHESIS (H0)
There is no difference in
the analgesic effect of mud therapy and Mustadi Upnaha in tennis elbow. |