| CTRI Number |
CTRI/2023/04/051335 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
05/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Marma Chikitsa Agnikarma and Physiotherapy in Avabahuka (Frozen shoulder) |
|
Scientific Title of Study
|
Three parallel arm study to evaluate comparative efficacy of Marma chikitsa Physiotherapy and Agnikarma in Avabahuka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amol Deshpande |
| Designation |
Assistant professor |
| Affiliation |
Datta Meghe insitute of higher education and research Salod |
| Address |
Mahatma Gandhi Ayurved Hospital and research centre Datta
Meghe Institute Of Medical sciences Salod Wardha Maharashtra
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442004
India |
| Phone |
9146131519 |
| Fax |
|
| Email |
deshapndeamol86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priti Desai |
| Designation |
Professor |
| Affiliation |
Datta Meghe insitute of higher education and research Salod |
| Address |
Mahatma Gandhi Ayurved Hospital and research centre Datta
Meghe Institute Of Medical sciences Salod Wardha Maharashtra
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442004
India |
| Phone |
|
| Fax |
|
| Email |
drprdesai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amol Deshpande |
| Designation |
Assistant professor |
| Affiliation |
Datta Meghe insitute of higher education and research Salod |
| Address |
Department of Rachana sharir Mahatma Gandhi Ayurved Hospital and research centre Datta
Meghe Institute Of Medical sciences Salod Wardha Maharashtra
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442004
India |
| Phone |
9146131519 |
| Fax |
|
| Email |
deshpandeamol86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Medical science Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Medical science |
| Address |
Datta Meghe Institute Of Medical science Wardha Maharashtra |
| 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 |
| Amol Deshpande |
Mahatma Gandhi Ayurved college hospital and research centre Salod Wardha |
Kayachikitsa
Department
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9146131519
deshpandeamol86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGACHRC IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: Avabahuka, (2) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: , Procedure details: Identify the site of the Marma,
Kshipra, Manibandha,
Indrabasti Kurpur, Aani and
Bahavi
Stimulate each Marma
by pressing it for 15/16 times for
1 second.
Repeat this
procedure thrice with resting
period of 5 min in between. ?
One empty capsule twice a day
after meal for 15 Days as a
placebo.Procedure will repeat
after 7 days.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Physiotherapy | Three techniques will be used in
this procedure • Ultra sound –
for tenderness, ultrasound of
continuous mode at 1 MHz, 2
w/cm2 for 4 minutes to shoulder
joint • TENS- for Pain
Management, low rate high
intensity TENS for 20 minutes •
Mobilization Exercises for –
ROM | | 3 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: , Procedure details: By using the Gas Burner Agni Shalaka (Copper) is heated up
to Red Hot color. Red Hot
Shalaka is placed over the
Marked area up to the
Samyakdagdha Sign
Procedure will be conducted in
doted manner.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All subjects irrespective of sex having age between 20 to 60 years
Patient having classical symptoms of Avabahuk.
Patient fit for Agnikarma and Marma Chikitsa. |
|
| ExclusionCriteria |
| Details |
Age group less than 20 and exceeding 60 are to be excluded
Patient having history of Trauma at effected limb |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Efficacy of Marma Chikitsa,
Agnikarma, and physiotherapy is Avabahuka |
Assessed at baseline and 15 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess efficacy of Marma Chikitsa in
Avabahuka.
2. To study efficacy of Agnikarma in Avabahuka.
3. To study efficacy of Physiotherapy in
Avabahuka.
4. To compare efficacy of Marma Chikitsa,
Agnikarma and physiotherapy in Avabahuka |
Assessed at baseline and 15 day |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1 |
|
Date of First Enrollment (India)
|
15/04/2023 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Frozen shoulder or adhesive capsulitis is a disease that usually occurs between the age group of 40-70 years; the
females and diabetic patients more prone to the disease. Physiotherapy and Agnikarama are the commonest modalities used for
the treatment of this disease in contemporary science and Ayurveda respectively. The traditional Vaidyas, Nadi Vaidya and bonesetters are commonly practising another modality called Marma Chikitsa, however, the literature regarding this is very sparse.
Objective: To compare the efficacy of Marma Chikitsa, Agnikarma and physiotherapy in Avabahuka.
Methods: 150 patients of Avabahuka (frozen shoulder) will be randomly allotted to three groups having 50 patients in each.
Group A will be treated with the Marma Chikitsa for the alternate day. Group B will be treated with the Agnikarma, which will be
repeated after 7 days, such three settings will be done. Group C will be treated with the physiotherapy for 15 continues days
which shall include Ultrasound, TENS and Exercise for a range of motion (ROM). Statistical Analysis will be done after the last
visit of the patient for the anticipative outcome by using Paired t-test, Unpaired t-test and one way ANOVA tests.
Results: We anticipate that Marma Chikitsa may have a better outcome as compared to Agnikarma and Physiotherapy.
Conclusion: Marma Chikitsa will be the new inclusion in the therapeutic model of Avabahuka and also can be studied in different musculoskeletal disordersr |