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CTRI Number  CTRI/2024/03/064125 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study for validating the effectiveness of Tendoease tablet in the rehabilitation of tendonitis. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled clinical trial validating the effectiveness of Tendoease tablet in the rehabilitation of tendonitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/22-23/016 Version: 1.00 dated 02 March 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amitava Narayan Mukherjee 
Designation  Senior Consultant 
Affiliation  Orthopaedic and Joint Replacement Clinic 
Address  Narayanpur Swagat Aashiyana ground floor 217A Bus stand Battala Kolkata

Kolkata
WEST BENGAL
700136
India 
Phone  9831504096  
Fax  -  
Email  amitavanarayan9051@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rumaiza Mamsa 
Designation  Medical services 
Affiliation  Meyer Organics Pvt Ltd 
Address  First floor Medical service department A 303 Road No 32 Wagle Estate Thane Mumbai

Mumbai
MAHARASHTRA
400604
India 
Phone  9167846090  
Fax  9162757002  
Email  rmamsa@meyer.co.in  
 
Details of Contact Person
Public Query  
Name  Varsha Chhabria 
Designation  Medical services 
Affiliation  Meyer Organics Pvt Ltd 
Address  First floor Medical service department A 303 Road No 32 Wagle Estate Thane Mumbai

Mumbai
MAHARASHTRA
400604
India 
Phone  7066706538  
Fax  9162757002  
Email  vchhabria@meyer.co.in  
 
Source of Monetary or Material Support  
Meyer Organics Pvt Ltd A-303, Road No. 32, Wagle Estate, Thane Mumbai Maharashtra 400 604 India 
 
Primary Sponsor  
Name  Meyer Organics Pvt Ltd 
Address  A-303, Road No. 32, Wagle Estate, Thane Mumbai Maharashtra 400 604 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Bathla  Health Square Clinic  Bhasha Bhawan Rd, Sheran Wala Gate, Patiala, Punjab 147001, India
Patiala
PUNJAB 		 9914886421
-
gauravbathla22@yahoo.co.in 
Dr Narendra Vaidya  Lokmanya Medical Research Centre and Hospital  Fourth floor OPD 401,314 B, Telco Road, Chinchwad
Pune
MAHARASHTRA 		 9822057766
-
drnarendravaidya490@gmail.com 
Dr Amitava Mukherjee  Orthopedic Joint Replacement Clinic  B 1-1, Rajarhat Road, Baguiati, Kolkata–700059, India
Kolkata
WEST BENGAL 		 9051342347
-
amitavanarayan9051@gmail.com 
Dr Akash Saraogi  Saraogi Healthcare  First Floor, Shah Trade Centre, Malad East, Mumbai, Maharashtra 400097,India
Mumbai
MAHARASHTRA 		 9967357178
-
saraogiakash@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre   Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  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, (2) ICD-10 Condition: M678||Other specified disorders of synovium and tendon,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo tablet  One Placebo tablet twice daily 30 minutes after lunch and dinner for 90 days. 
Intervention  Tendoease tablet  One Tendoease tablet twice daily 30 minutes after lunch and dinner for 90 days. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects meeting all of the following criteria will be eligible for the study: 1. Male and female subjects aged between 16-50 years (both inclusive);2. Subjects with clinical or ultrasound-confirmed Achilles tendonitis, lateral epicondylitis or patellar tendonitis;3. Subject with relapse cases of tendinosis;4. Subjects with or without comorbidities, if comorbidity exists should be on stable prescription for more than three months;5. Willing to provide consent and willingness for follow-up. 
 
ExclusionCriteria 
Details  Subjects meeting any of the following criteria will not be eligible for the study:
1. Preoperative shoulder fracture, irreparable tendon tear (Exceeding 50%),
calcifying tendinitis, shoulder instability, acromioclavicular joint disorder,
infection, neoplasm, symptomatic cervical spine disease, rheumatoid
arthritis or immune disease, gout or uric acid disease;
2. Subjects allergic to the investigational product ingredients;
3. Subjects with any acute illness requiring immediate medical care;
4. Subjects with uncontrolled diabetes/ complicated cardiovascular
diseases/ history of TIA, cerebrovascular accident, stroke or any
revascularization;
5. Known subjects of hepatic or renal impairments;
6. Pregnant, breastfeeding or planning to become pregnant during the study;
7. Any other condition which proves subject unfit for the study
participation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary endpoints of the study will be to assess:
1. Changes in pain score on 0-10 visual analog scale (VAS).
2. Changesin echo texture, thickness, tendon sheath, paratenon, vascularity,
and tendon movement by radiological investigations. 		 Screening to end of
the study 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary endpoints of the study will be to assess:
1. Changes in inflammatory markers like IL-6, TNF-alpha, procollagen type
I N-terminal pro-peptide (PINP), platelet-derived growth factor (PDGF)
etc.
2. Changes in health-related quality of life (HRQOL) score.
3. Changes in symptom grading on a 4-point Linkert scale for swelling,
tenderness, etc.
4. Changes in the requirement of rescue medication. 		 Screening to end of
the study 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   23/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/03/2024 
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   Tendonitis, a common form of tendinopathy, results from acute tendon injury accompanied by inflammation and reduced function, often caused by overloading the tendon. It can progress to tendinosis, a degenerative condition, if not properly managed. Risk factors include age, sudden changes in activity levels, medications, and comorbidities like diabetes and obesity. Treatment options range from physical therapies to pharmacological interventions, with emerging interest in nutraceutical supplementation. Nutraceuticals, when combined with conventional treatments, offer promise in managing tendonitis by potentially reducing pain and improving function. The rationale for investigating Tendoease tablet supplementation lies in its potential to enhance tendon rehabilitation outcomes, contributing valuable insights into multidisciplinary approaches for tendonitis management. This study aims to evaluate the safety and effectiveness of Tendoease tablets as an oral supplement, highlighting their role in enhancing tendonitis rehabilitation protocols. 
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