| CTRI Number |
CTRI/2024/06/068671 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Marmachikitsa and Agnikarma] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effects of two therapies, Marmachikitsa and Agnikarma in the management of Tennis Elbow. |
|
Scientific Title of Study
|
A Open Label Randomized Controlled Trial on Marmachikitsa in the management of Sport injury 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 Nirmala Chandrabhanji Apaturkar |
| Designation |
PhD Scholar |
| Affiliation |
Govt Ayurved College, Nagpur |
| Address |
OPD No.3 , Shalyatantra Department,Government Ayurved College and Hospital, Sakkardara Square,Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8600503837 |
| Fax |
|
| Email |
drnirmala21f@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Y Raut |
| Designation |
Professor(Shalyatantra) and Dean Govt, Ayurved College,Nagpur |
| Affiliation |
Government Ayurved College |
| Address |
Govt Ayurved College,Department of Shalyatantra,Raje Raghuji Nagar,Sakkardara square,Chota Tajbag roadNagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422108928 |
| Fax |
|
| Email |
drsyraut@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhash Y Raut |
| Designation |
Professor(Shalyatantra) and Dean Govt, Ayurved College,Nagpur |
| Affiliation |
Government Ayurved College |
| Address |
Govt Ayurved College,Department of Shalyatantra,Raje Raghuji Nagar,Sakkardara square,Chota Tajbag roadNagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422108928 |
| Fax |
|
| Email |
drsyraut@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital, Raje Raghuji Nagar, Umred Road,Nagpur 440024 |
|
|
Primary Sponsor
|
| Name |
Dr Nirmala Chandrabhanji Apaturkar |
| Address |
Government Ayurved College and Hospital,Department of Shalyatantra,2nd floor, Raje Raghuji Nagar, Umred Road, Nagpur-440024 |
| Type of Sponsor |
Other [self] |
|
|
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 Nirmala Chandrabhanji Apaturkar |
Government Ayurvedic College and Hospital, Nagpur |
OPD No 3, Shalyatantra OPD,Government Ayurved College and Hospital,Raje Raghuji Nagar,Umred Road, Sakkardara Square, Nagpur-440024
Nagpur
MAHARASHTRA |
8600503837
drnirmala21f@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,Government Ayurved College,NAgpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M678||Other specified disorders of synovium and tendon. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Su. Su 11, Procedure details: After performing proper purvakarma a small amount of Guda & water is taken & heated over the stove.Then the sticky guda should be sucked using a Borosil glass pipette poured on the predetermined site dropwise & wiped off after cooling to produce Samyaka bindu dagdha. After Agnikarma Aloe Vera pulp will be applied to relieve burning sensation.In pashchyat karma Honey & Ghrita will be applied over dagdha vrana. WEEKLY ONCE FOR 15 DAYS)
| | 2 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Dr. PradipkumarG.Marmachikitsa- Basic tenets in Ayurveda and thrapeutic approach published by CCRAS, Procedure details: After performing proper purvakarma ,1.the Marmachikitsa will be given to kurparmarma .
2. The Marma will be stimulated 3-5 times in the same rhythm of inhale and exhale by digital pressure in one sitting.
3.The rhythm of stimulation is same as the rhythm of respiration i.e. approx. 18 to 20 times per minute i.e. pressure applied for 0.8 sec.
4.The kurpar Marma can be pressed for 3-4 times a day.
In pashchyat karma , the site will be rubbed gently to avoid the creation of a mark at the site.
Duration : daily 3-4 times for 15 days
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from Tennis elbow (Pain, Stiffness and Restricted range of motion of elbow joint (ROM) with VAS more than 4.
2. Patients willing to undergo trial.
3. Patients with the age group 20-50 years .
4. Patient with H/o repeated trauma to elbow joint
5. Patient with c/o Tennis elbow more than 3 months.
6. Patients with controlled diabetes mellitus
|
|
| ExclusionCriteria |
| Details |
1. Not willing to undergo trial.
2. Age below 20 years and above 50 years..
3. Patient with H/o inflammatory arthiris or gross structural abnormality.
4. Patient with any co existing major illness like cardiac diseases, TB, Asthama.
5. Patients associated with Golfer’s elbow,Olecranon bursitis, Radial tunnel syndrome etc.
6. Patients with history of compound fracture, Pathological fracture, nonunited fracture and mal-united fracture of complaining limb.
7. Patient with significant radiculopathy.
8. Patient with any Neoplastic lesion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effects of Marmachikitsa in the management of Tennis
elbow with grade reduction in 1.Kurpar sandhi Stambha (Stiffness in elbow joint) 2.Kurpar sandhi Shopha (Elbow swelling)
|
At baseline, 1 week,2 weeks,4 weeks,and 6 weeks (follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Agnikarma in the management of Tennis elbow.
2.To compare the effects of Marmachikitsa & Agnikarma for Tennis elbow
by objective criteria 1.Akunchana Prasharana Apravritti (Range of movement will be measured with Goniometer) .
• Flexion -
• Extension –
2.Questionnaire ( The patient specific functional scale)
3.Weakness on Grip test ( by Dynamometer )
4.VAS scale for pain
|
At baseline, 1 week,2 weeks,4 weeks,and 6 weeks (follow up) |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/06/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This study is an open labelled, randomized ,parallel group,controlled trial to study the effects of MARMACHIKITSA in the management of Tennis elbow.Total 128 subjects fulfilling inclusion criteria will be selected for study and divided into two groups(group A and group B) by Computerized Generated Randomized method.The subjects of Group A will be given Marmachikitsa daily and group B will be treated by Agnikarma with Guda paka(Maximum 02 sittings of 01-week interval) for 15 days.Assessment will be done based on subjective and objective parameters on D1, D8, D15, D30 and D45 (follow up).The primary outcome measures will be relief from the symptoms of Tennis elbow like 1.Kurpar sandhi Stambha (Stiffness in elbow joint) and 2.Kurpar sandhi Shopha (Elbow swelling). The secondary outcome measures will be overall improvement in the objective criterias like 1.Akunchana Prasharana Apravritti (Range of movement will be measured with Goniometer) 2.Questionnaire ( The patient specific functional scale)3.Weakness on Grip test ( by Dynamometer )4.VAS scale for pain.Statistical analysis with appropriate tests and interpretation will be done after the study and conclusion will be drawn. |