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CTRI Number  CTRI/2023/09/057317 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical study to understand the safety and effectivesness of a new product on adult males and females having joint pain. 
Scientific Title of Study   A Randomized, Double Blinded, Placebo Controlled, Two Arm, Single- Centric, Clinical Trial to Assess the Safety and Efficacy of Axtragyl® in Subjects Experiencing Joint (Knee) Pain Compared to Placebo. 
Trial Acronym  NIL 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Girish HR 
Designation  Principal Investigator 
Affiliation  Consultant Orthopedician, Rajalakshmi Hospital and Research Center 
Address  Rajalakshmi Hospital and Research Center. Ground Floor, Room Number-2, No.21/1, Lakshmipura Main Road, Vidyaranyapura Post.

Bangalore
KARNATAKA
560097
India 
Phone  9845516613  
Fax    
Email  girirudra@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Subramanian 
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt. Ltd 
Address  Manidweep, 3rd Floor, C-2, No.13, Dynasty Layout Mariannapalya, H.A. Farm (post), Hebbal

Bangalore
KARNATAKA
560024
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian 
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt. Ltd 
Address  Manidweep, 3rd Floor, C-2, No.13, Dynasty Layout Mariannapalya, H.A. Farm (post), Hebbal


KARNATAKA
560024
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
GIELLEPI S.p.A Via G. Verdi 41Q, 20831 Seregno (MB), ITALY 
 
Primary Sponsor  
Name  GIELLEPI S.p.A 
Address  Via G. Verdi 41Q, 20831 Seregno (MB), ITALY  
Type of Sponsor  Other [Manufacturer, Limited Company] 
 
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 Girish HR  Rajalakshmi Hospital and Research Centre  Room number-2, No.21/1., Lakshmipura Main Road, Vidyaranyapura Post.
Bangalore
KARNATAKA 		 9845516613

girirudra@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Axtragyl®  Axtragyl® administered as a capsule. Each recruited patient will orally intake two 240mg capsule once a day after breakfast for 28 days. 
Comparator Agent  Placebo  Placebo administered as a capsule. Each recruited patient will orally intake two 240mg capsule once a day after breakfast for 28 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Physically active healthy subjects (both women and men) without any joint’s diseases including osteoarthritis as well as rheumatoid arthritis.
2. Adult subjects (18 - 60 years old) experiencing joint (knee) pain (not associated with acute injury or long-standing disease).
3. Subjects should not have knee pain at rest but mild to moderate knee joint pain after 6 min walk test at a moderate-to brisk pace.
4. BMI <27.
5. Subjects with normal ECG readings on screening.
6. Subjects with normal creatine kinase.
7. Patients ready to give written informed consent and willing to
comply with the study protocol. 
 
ExclusionCriteria 
Details  1.Consuming any herbal supplement/drug, including both systemic and local ones, showing anti-inflammatory and/or analgesic action.
2. Subjects with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management.
3. Subjects with uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles.
4. Subjects with known history or diagnosis of osteoarthritis and rheumatoid arthritis as well as other joint disease.
5. Subjects with joint surgery during 3 months before screening.Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
7. Cancer and any other diseases interfering with study procedures or safety.
8. Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential.
9. Presence of any severe medical or psychological condition or
chronic condition/inflammation/infection that in the opinion of the investigator would compromise the patient’s safety or successful participation in the study.
10. Participation in any other clinical study within 30 days of screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1.Improvement of knee pain using assessment VAS after 6-minute walk test.
2.Change in WOMAC score.
3. Improvement in SCT.
4. Improvement in (range of motion) ROM.
5. Reduction of CRP.
6.Overall Assessment of treatment satisfaction & tolerability. 		 Baseline Day 5 14 28 
 
Secondary Outcome  
Outcome  TimePoints 
1.Physical Examination
2.Vital Signs: Pulse rate, blood pressure & body temperature
3.Lab assessment
4.Adverse Event Assessments 		 Screening & Day 28 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 05/10/2023 
Date of Study Completion (India) 28/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
This study is conducted in a single clinical site having an Institutional Ethics committee, which is registered with CDSCO. Subjects diagnosed with knee joint pain not associated with acute injury or long standing disease satisfying all the inclusion/exclusion criteria will be identified and screened for the study.
Upon randomization, those subjects who meet the I/E criteria will be assigned to either Investigational product or placebo. They will be dispensed with the medication in this visit and visit plan will be also provided. Day of screening, Physicals, Vitals, Demographics and labs will be recorded. On Day 0, Knee pain using VAS after 6 minute walk, Womac scoring, STC test and Goniometry will be evaluated. IPs will be dispensed in this visit only. The same tests will be performed on Day 5, 14 and 28.
On Day 28, all the above mentioned tests will be performed. Collection of used IP. Overall satisfaction. Assessment of tolerability will be recorded . 
Type of study- Randomized placebo controlled for parallel groups.
 
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