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CTRI Number  CTRI/2025/03/083633 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of digital pressure stimulation and cauterisation in frozen shoulder  
Scientific Title of Study   An Anatomical and clinical study on Amsa Marma with special reference to Avabahuka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjusha Rajan N 
Designation  Junior Resident 
Affiliation  Banaras Hindu University 
Address  Department of rachana sharir faculty of ayurveda ims bhu varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8714008488  
Fax    
Email  anjusharajan1034@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Laxmi Gautam 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of rachana sharir faculty of ayurveda ims bhu varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451440263  
Fax    
Email  vlaxmi40@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijay Laxmi Gautam 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of rachana sharir faculty of ayurveda ims bhu varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451440263  
Fax    
Email  vlaxmi40@gmail.com  
 
Source of Monetary or Material Support  
department of orthopedics IMS BHU Varanasi 221005  
department of panchakarma faculty of ayurveda IMS BHU Varanasi 221005 
 
Primary Sponsor  
Name  department of rachana sharir faculty of ayuveda 
Address  Institute of medical sciences banaras hindu university varanasi 221005 Uttar Pradesh India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjusha Rajan N  sir sundarlal hospital  OPD NO 16C (Department of Panchakarma) Indian medicine wing institute of medical sciences Banaras Hindu University
Varanasi
UTTAR PRADESH 		 8714008488

anjusharajan1034@gmail.com 
Dr Anjusha Rajan N  Sir Sunderlal Hospital  Orthopedics OPD(Department of Orthopedics) Trauma Center Banaras Hindu University
Varanasi
UTTAR PRADESH 		 8714008488

anjusharajan1034@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Institute of medical sciences Banaras Hindu University  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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: susrutha samhitha sutrasthana, Procedure details: cauterisation will be done 3 times at 15 days interval)
(1) Medicine Name: Aceclofenac 50 mg +Paracetamol 500 mg, Reference: essentials of pharmacology, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 45 Days
(2) Medicine Name: Omeprazole 20 mg , Reference: essentials of pharmacology, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 20(mg), Frequency: od, Duration: 45 Days
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: susrutha samhitha, Procedure details: cauterisation will be done 3 times at 15 days interval)
(1) Medicine Name: maharasnadi kwatha, Reference: sahasrayoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 45 Days
3Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: susrutha samhitha sharirasthanam, Procedure details: 2 times a day digital pressure will be applied over amsa marma region)
(1) Medicine Name: maharasnadi kwatha, Reference: sahasrayogam, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 45 Days
4Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: susrutha samhitha sharirasthana, Procedure details: 2 times a day digital pressure will be applied over amsa marma region)
(1) Medicine Name: Aceclofenac 50 mg +Paracetamol 500 mg, Reference: essentials of medical pharmacology, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 45 Days
(2) Medicine Name: Omeprazole 20 mg , Reference: essentials of medical pharmacology, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 20(mg), Frequency: bd, Duration: 45 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Clinical symptoms with or without restriction of shoulder movements 
 
ExclusionCriteria 
Details  Pregnancy
Patient suffering from paralysis, cardiovascular disease, neoplastic disorders, or any severe illness.
Severely malnourished, debilitated
Myelopathy, any type of malignancy
Previous malunion/deformity of the ipsilateral limb
 
 
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 
relief in pain with improvement in range of motion  change in score of SPADI VAS and CMS from baseline and after 45 days  
 
Secondary Outcome  
Outcome  TimePoints 
reduction in scoring on the following scale-
. visual analog scale
. SPADI
. CMS 		 45 days study with follow up every 15 days 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 3 
Date of First Enrollment (India)   08/04/2025 
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  
180 cases of frozen shoulder will be included in this interventional study which will be randomly divided into 4 groups. First group will be prescribed with  Maharasnadi Kwatha with amsa marma therapy. Second group will be prescribed with Maharasnadi Kwatha with agni karma. Third group will be prescribed with ( Aceclofenac 50 mg +Paracetamol 500 mg) +Omeprazole 20 mg along with marma therapy. Fourth group will be prescribed with ( Aceclofenac 50 mg +Paracetamol 500 mg) +Omeprazole 20 mg along with agni karma.
 
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