FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091686 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of shoulder pain with multiple ayurveda procedures 
Scientific Title of Study   Efficacy of Multi modal approach in the management of Chronic Rotator Cuff injury A Randomized controlled trial 
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 Santosh G Sharma 
Designation  PG Scholar 
Affiliation  KAHER shri B M K Ayurveda Mahavidyalaya 
Address  Room number 8 Department of Shalyatantra KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India

Belgaum
KARNATAKA
590003
India 
Phone  9665107219  
Fax    
Email  sharmasantosh09272@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh S Killedar 
Designation  Associate Professor 
Affiliation  KAHER shri B M K Ayurveda Mahavidyalaya 
Address  Room number 8 Department of Shalyatantra KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India

Belgaum
KARNATAKA
590003
India 
Phone  9035987505  
Fax    
Email  drramesh39@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ramesh S Killedar 
Designation  Associate Professor 
Affiliation  KAHER shri B M K Ayurveda Mahavidyalaya 
Address  Room number 8 Department of Shalyatantra KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India

Belgaum
KARNATAKA
590003
India 
Phone  9035987505  
Fax    
Email  drramesh39@gmail.com  
 
Source of Monetary or Material Support  
KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India Pin code 590003 
 
Primary Sponsor  
Name  Dr Santosh G Sharma 
Address  PG Scholar Department of Shalyatantra KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India Pin code 590003 
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 Santosh G Sharma  KAHER shri B M K Ayurveda Mahavidyalaya   Room number 8 Department of Shalyatantra Division General Shalya OPD
Belgaum
KARNATAKA 
09665107219

sharmasantosh09272@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M751||Rotator cuff tear or rupture, notspecified as traumatic. Ayurveda Condition: AMSA-MARMAVIDDHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Multimodal therapyIt will be recommended to take 500 mg tablets of oral acetaminophen twice a day for 14 days Transcutaneous electrical nerve stimulation and Hot moist pack therapy for 7 days and exercise therapy will be administered to the participants for 14 days TENS treatment will be administered continuously for 20 minutes at a strength of 40 μSN and 100 Hz while hot pack therapy will be used for 20 minutes Rotator Cuff Exercises Stretching Exercises and Postural and Mobility Exercises such as Resisted internal and external rotation Pectoralis minor stretch Corner stretch and Thoracic extension over towel will be performed ten repetitions a day for a period of 14 days
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: SU SU 12 chapter 10 shloka, Procedure details: Agnikarma with Panchaloha shalaka will be done on day 1 and day 7 Yoga asanas or yoga postures will be carried out for 30 minutes once daily for 14 days )
(1) Medicine Name: Trayodashang Guggulu, Reference: Bhaishajya Ratnavali Vatvyadhi Adhikar chapter 98 verse 101, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 14 Days
(2) Medicine Name: Murivenna taila, Reference: the pharmacopoeia of government ayurveda college tiruvanthapuram , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Duration: 14 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Shoulder pain for minimum 3 months elicited in the anterolateral shoulder region
2 Resting pain at 2 out of 10 maximum on verbal NPRS
3 At least 3 out of 5 provocative tests positive that are Neer test Hawkins Kennedy test Jobe test Painful arc between 60° and 120° and external rotation resistance test
4 Yogya for Agnikarma
 
 
ExclusionCriteria 
Details  1 Glenohumeral osteoarthritis or other inflammatory arthritis
2 Fracture or dislocation of shoulder
3 Previous cervical or shoulder surgery
4 Osteoporosis
5 Neurological disorders like Alzheimers Disease Bells Palsy Epilepsy and Seizures
6 Tumour
7 Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Numeric pain rating scale
2 Visual analog scale
3 Muscle strength by hand held dynamometer or traction dynamometer
4 Range of motion by goniometry
 
Day 0 Day 7 Day 14 Day 21 Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
1 Shoulder pain and disability index
2 Eq5d quality of life index questionnaire  
Day 0 Day 7 Day 14 Day 21 Day 30 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/09/2025 
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="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  

Rotator cuff injuries (RCI) are common orthopaedic problem, prevalence of 20% in the general population which increases with age. While 50% of injuries are degenerative and occur in patients over 80, a large subset of injuries occurs in the athletic population. Athletes at particular risk for RCI include throwing athletes, overhead athletes, and those in contact sports. The best available evidence is specific to baseball throwers; however, clinicians should keep in mind the forced overhead mechanism required in tennis, golf, basketball, volleyball, track & field (throwers), lacrosse, and swimming athletes who experience significant and prolonged stress on the shoulder over the course of their athletic careers. Though a younger, athletic cohort in tennis and baseball are primarily covered in this review, recreational and master overhead athletes may present with rotator cuff pathology as well. These injuries can significantly impair shoulder function, leading to pain, weakness, and restricted range of motion (ROM). Most rotator cuff injuries may be treated conservatively by using regimens of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and functional rehabilitation therapy. For patients who cannot tolerate NSAIDs, acetaminophen serves as a viable alternative. The choice between surgical and non-surgical management is influenced by several factors, such as location of injury, the patient’s age, activity level, and comorbidities. Despite its benefits, arthroscopic repair has some risks. Common complications include re-tear, infection, stiffness, and nerve injuy. In Ayurveda, it can be correlated with Amsa sandhi marmaghata. Amsa marma is a snayu gata marma, measuring half angula and injury leads to loss of function in arms. Bhagna chikitsa and vatvyadhi chikitsa principles should be incorporated during the treatment of Marmaghata. Agnikarma is indicated for pain management in the diseases of Sira Snayuagata vata. Research have showed that usage of oral medications is effective in the pain management of marmaghata, among them Trayodashanga guggulu and Murivenna taila are proved to have efficacy in the musculoskeletal pain management. Multi Modal approach is the need of the hour and it provides improvements in pain and function in patients with chronic pain compared with usual care.Yoga (Asana) is a non-invasive modality commonly used in the rehabilitation of shoulder injuries which improves muscle flexibility by improving the natural alignment of joints. A special Multi Modal treatment plan is planned by incorporating Ayurveda (Agnikarma, oral medicine like Trayodashanga guggulu and local application of Murivenna taila) and yoga (Asana) to manage the rotator cuff injury. Hence with this objective the study will be undertaken to evaluate the efficacy of Multi Modal approach in the management of rotator cuff injury.

 
Close