| CTRI Number |
CTRI/2024/10/075812 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Marma Therapy in the cases of Frozen Shoulder |
|
Scientific Title of Study
|
Efficacy of Marma Chikitsa as a non-pharmacological intervention in Frozen shoulder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REKHA PHULL |
| Designation |
Professor and HOD |
| Affiliation |
SGT UNIVERSITY |
| Address |
HOD Department of Kayachikitsa, FIMS, SGT University, Gugaon-Badli road, Chandu Budhera, Gurugram,
Gurgaon HARYANA 122505 India |
| Phone |
09555953332 |
| Fax |
|
| Email |
drrekhasharma99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
GAURAV PHULL |
| Designation |
Deputy Medical Superintendent |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar, Najafgarh
South West DELHI 110073 India |
| Phone |
9990448807 |
| Fax |
|
| Email |
drgauravphull18@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
GAURAV PHULL |
| Designation |
Deputy Medical Superintendent |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar, Najafgarh
South West DELHI 110073 India |
| Phone |
9990448807 |
| Fax |
|
| Email |
drgauravphull18@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Chandu budhera, gurugram, Haryana, 122505 |
| 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 Rekha Phull |
FIMS Ayurveda hospital |
room no. 6, Kayachikitsa OPD,Ground floor, Ayurveda hospital (FIMS) SGT University, Chandu Budhera, Gurugram, Haryana Gurgaon HARYANA |
9555953332
drrekhasharma99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Faculty of medicine and health sciences |
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: AVABAHUKAH, (2) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. 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¤•ितà¥à¤¸à¤¾ | (Procedure Reference: ccras literature, Procedure details: (Procedure Reference: Marmacikitsa CCRAS 2020, Procedure details: kshipra, indrabasti, kurpar, Aani, Urvi, Ansa, Ansaphalaka. All these marma points will be stimulated by pressure technique on alternate days for a total of 7 sittings. total duration is 14 days.))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for the trial will be the first and foremost criteria
Patients between 18-60 yrs of age irrespective of gender and religion
Patients having clinical features of adhesive capsulitis/ frozen shoulder
|
|
| ExclusionCriteria |
| Details |
Patients having serious ailments like uncontrolled dibetes mellitus, chronic alcoholic patient, trauma involving bony injury or joint dislocation, rheumatoid arthritis.
Immuno-compromised patients- Hepatitis-B,C positive or HIV positive,tuberculosis, cancer patients.
Patients on steroids for any other disease.
Pregnant females and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in range of motion (ROM) and decrease in pain.
change in value of Biomarkers |
baseline, day 1(after 1st sitting), day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in daily routine of patient
improvement in ease of movement |
after 14 days and 1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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 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
|
The majority of ailments in today’s rapidly evolving
technology society may not be life threatening but they nonetheless interfere
with daily living and reduce productivity. Among those is Frozen shoulder(Avabahuka)diseases
that are painful and have an impact on a person’s daily activities. The
term frozen shoulder(Avabahuka)
was first coined by Acharya Sushruta where he has described Samprapti
(Pathogenesis) and Rupa (Symptom) of frozen
shoulder (Avabahuka).It caused mainly by people
suffering from stroke connective tissue diseases, shoulder conditions like
calcific tendonitis, rotator cuff tear & women belonging to 4th or 5th
decade are more susceptible, immobilization and trauma to shoulder.
The worldwide prevalence of the frozen
shoulder is 2 % to 3%. It usually occurs between 40-70 years of age. Females
are more prone to diseases than male.The
incidence of frozen shoulder is 2-4 times higher in diabetes than the general
population.However, it is a typical contributor
to disability and shoulder pain in the general population. Although, it is a
self-limiting condition, the patient is forced to seek therapy due to its
rather lengthy, limiting, and painful course. NSAIDS and physical therapy are
the major forms of treatment for frozen shoulder (Avabahuka) at the moment along
with alternative options include manipulation under anaesthesia (MUA), active
and passive exercises. If these non-operative methods fails
then surgery is executed.Despite
of treatment, the recovery time is quite long and frustrating for the patient. According
to pain gate theory by
Marma Therapy, acute pain is stimulated, which blocks the transfer of chronic
pain, thus increasing the threshold of pain by stimulating the particular
Marma. Continuous stimulation of the Marma Sthana Increases the Nerve
conduction, Muscle conduction as well as improves the blood circulation of
Shoulder joint by Continuous stimulation of artery, vein and nerves, which
surrounds and supply the whole shoulder region thus, helps in recovery of the
Shoulder Movement.
|