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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  
SGT University, Gurugram 
 
Primary Sponsor  
Name  SGT University 
Address  Chandu budhera, gurugram, Haryana, 122505 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (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.



 

 

 

 

 

 

 
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