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CTRI Number  CTRI/2024/07/070014 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find out the effect of thermal microcautery and vital point stimulation in frozen shoulder. 
Scientific Title of Study   An open label comparative study to evaluate the efficacy of Marma chikitsa and Agnikarma in the management of Avabahuka WSR to 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  Dr Aswathy K 
Designation  Associate professor 
Affiliation  Madhya Pradesh Medical Science University, Jabalpur, Madhya Pradesh 
Address  Mansarovar ayurvedic medical college hospital and research centre. Dept of prasuti tantra evum stri roga. 3rd Floor Room no -9 Ward 64 Kolar road Bhopal Ward 84

Bhopal
MADHYA PRADESH
462042
India 
Phone  9747838548  
Fax    
Email  draswathy88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Omprakash Dave 
Designation  Professor 
Affiliation  Parul University, Vadodara, Gujarat 
Address  Parul institute of ayurveda and research Dept of Shalya tantra 3rd floor Room no - 404 Parul university Limda Waghodia taluk Vadodara dist

Vadodara
GUJARAT
391760
India 
Phone  9460770626  
Fax    
Email  omprakash.dave86277@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Omprakash Dave 
Designation  Professor 
Affiliation  Parul University, Vadodara, Gujarat 
Address  Parul institute of ayurveda and research Dept of Shalya tantra 3rd floor Room no - 404 Parul university Limda Waghodia taluk Vadodara dist

Vadodara
GUJARAT
391760
India 
Phone  9460770626  
Fax    
Email  omprakash.dave86277@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Mansarovar ayurvedic medical college hospital and research centre Ward 64 Kolar road Bhopal Madhya pradesh India Pin - 462042 
 
Primary Sponsor  
Name  Dr Aswathy K 
Address  Kannadath house Cheruvannur Feroke post Kozhikode Kerala 673631 
Type of Sponsor  Other [self] 
 
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 Anurag Singh Rajput  Mansarovar ayurvedic medical college and research centre  Dept of Shalya tantra. 1st floor, room no- 104 2nd floor, room no- 203
Bhopal
MADHYA PRADESH 		 8103878703

vd.anuragsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul institute of ayurved  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: Avabahukah,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susrutha samhitha - sandhighata vyadhis, Procedure details: Instrument using - swarna shalaka. Type of dahana- bindu dahana visesha. Position - at the most tender point of the shoulder joint. 06 sittins in 15 days with regular intervals - 10 to 20 bindus per sitting on demarcated site. Duration - 15 days.)
2Comparator ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Susrutha sammhitha sarira sthana, Procedure details: Method - patient will be kept in supine position. Site of marma - kakshadhara, amsa, amsaphalaka, kurpara, aani and kshipra will be identified. Time of therapy - each marma will be stimulated by giving adequate digital pressure with thumb or finger for 15/ 16 times for 1 second. this procedure will be repeated thrice with a resting time of 5 minute in between.marma chikitsa will be given after the first assessment in a gap of two days. Duration- 15 days. )
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Patient fulfilling diagnostic criteria.
2)Patient irrespective of gender, religion, occupation,socioeconomic status etc will be included in the study.
3)Shoulder pain for at least 3 months and less than 12 months duration.
5)Patients with controlled diabetes mellitus and other systemic diseases such as hyperthyroidism and hypothyroidism.
6)Patients fit for agnikarma as per classics. 
 
ExclusionCriteria 
Details  1)Patients suffering from major trauma having dislocation or fracture of shoulder joint.
2)Patients of uncontrolled Diabetes mellitus.
3)Other diseases like Paralysis, Parkinson’s disease, cardiac diseases, renal diseases and endocrine diseases, severe Anemia, and Malignancy, tuberculosis
4)Pregnant and lactating female.
5)Patients contraindicated for Agnikarma as per classics.
6)Patients who need other emergency interventions like surgery.
7)Those patients who are regularly taking dependent on some specific medicines like anticoagulant, antiplatelet medicines, immunosuppressive medicines.
8)HIV and HbsAg reactive patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Pain relief will be there.
2)Stiffness will be reduced.
3) Range of movement will increase. 		 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
1) Regained day to day activities.
2) Functional progressions(power and endurance).
3) Reinforce confidence in future.
4) Motivation to keep moving shoulder and full body.
 		 1 months 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   02/09/2024 
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 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 a randomized , open label comparative study to evaluate the efficacy of marma chikitsa and agnikarma in the management of avabahuka WSR to frozen shoulder. The primary outcomes are relief in pain and stiffness with increase range of movements and thereby patient leading a healthy life within a month. The secondary outcomes are the patient regains his day to day activities, functional progressions, reinforce confidence in future and motivation to keep moving shoulder and full body.
Study design - An open labeled randomized comparative clinical study.
The patients will be divided randomly into two groups by computer generated randomized method.
GROUP  A 
Intervention - 50 patients of avabahuka will be treated with Agnikarma as well as Ashtavargam kashayam .
Instrument - Swarna shalaka.
Type - Bindu dahana visesha.
Position - At the most tender point of the shoulder joint.
Dose - 06 sittings in 15 days with regular intervals.
Follow up period - 15th day, 1st month, 3rd month.
GROUP B
Intervention - 50 patients of avabahuka will be treated with Marma chikitsa as well as Ashtavargam kashayam.
Site of the marma - Kakshadhara, Amsa, Amsaphalaka, Kurpara, Aani and Kshipra will be identified.
Method - Each marma will be stimulated by giving adequate digital pressure with thumb or finger for 15/16 times for one second. This procedure will be repeated thrice with resting 5 minute in between. Marma chikitsa will be given after the first assessment in a gap of 2 days.
Duration - 15 days.
Follow up - 15th day, 1st month, 3rd month.
SUBJECTIVE PARAMETERS
Pain in the shoulder region or upper arm(shoola).
Stiffness in the shoulder region or upper arm (stambha)
OBJECTIVE PARAMETERS
Restricted range of motion of shoulder joint(ROM) bahupraspanda haratvam such as adduction, abduction, flexion, extension, internal rotation, external rotation.
Range of movement calculated by adduction, abduction, flexion, extension, internal rotation, external rotation were recorded according to the actual values of goniometric readings.


 
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