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CTRI Number  CTRI/2021/09/036890 [Registered on: 27/09/2021] Trial Registered Prospectively
Last Modified On: 02/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Efficacy and tolerability Study of Amrutanjan advanced joint muscle plus spray for pain relief 
Scientific Title of Study   A Randomized, Open label, single arm, Interventional study to evaluate the Efficacy and tolerability of Amrutanjan advanced joint muscle plus spray for pain relief in patients with Musculo-skeletal and joint pain disorders. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Kannan 
Designation  Principal Investigator/Medical Consultant 
Affiliation  PM Medical Centre & KI3, CRO  
Address  Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu

Vellore
TAMIL NADU
632513
India 
Phone  7708925866   
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Kannan 
Designation  Principal Investigator/Medical Consultant 
Affiliation  PM Medical Centre & KI3, CRO  
Address  Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu

Vellore
TAMIL NADU
632513
India 
Phone  7708925866   
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kannan 
Designation  Principal Investigator/Medical Consultant 
Affiliation  PM Medical Centre & KI3, CRO  
Address  Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu

Vellore
TAMIL NADU
632513
India 
Phone  7708925866   
Fax    
Email  srkguruvarshan@gmail.com  
 
Source of Monetary or Material Support  
Amrutanjan Health Care Limited, Tamil Nadu, India. 
 
Primary Sponsor  
Name  Amrutanjan Health Care Limited Tamil Nadu India 
Address  103, (Old No. 42-45), Luz Church Road. Mylapore, Chennai- 600 004.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Ramesh Kannan   PM Medical Centre  Room no:10, Dept. of Medicine, OPD, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu
Vellore
TAMIL NADU 		 7708925866

srkguruvarshan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PM Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M259||Joint disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AMRUTANJAN ADVANCED JOINT MUSCLE PLUS SPRAY  Pudinah (Mentha arvensis - Aerial part, Satva) 9% Gandhapura patra taila (Gaultheria fragrantissima- Lf, Ol) 30% Karpura (Cinnamomum camphora- Aerial part, Satva) 7% Tailaparna taila (Eucalyptus globulus-Lf, Ol) 3% Solvent & Propellants q.s to 100% Dose:Spray Frequency :3to 4 times a day Route of Administration: topical  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients of either sex aged above 18 years.
2. Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
3. Patients who had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain disorders.
 
 
ExclusionCriteria 
Details  Patients presenting with any of the following will not be included in the trial.
1. Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period.
2. Subject with active skin lesions or other skin diseases.
3. Subject with history of uncontrolled diabetes (HbA1C of more than 9)
4. Known allergy to compounds of investigational product.
5. Fracture, Ligament tear, sports injury patient will be excluded
6. Subject undergoing physiotherapy session will be excluded.
7. Patients suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.
8. Participation in an investigational drug trial in the30 days prior to the screening visit.
9. Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
10. History of drug or alcohol abuse during the last 6 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to onset of relief of pain [Time frame: 0-120 minutes post dose]
Time to onset of cooling/warmth/tingling/burning sensation [Time frame: 0-120 minutes post dose]
Time to achieve complete relief of pain [Time frame: 0-120 minutes post dose]
Reduction in pain score on numeric pain rating scale AT REST [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 24 hours post dose]
 Reduction in pain score on numeric pain rating scale during MOVEMENT [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 24 hours post dose]
 		 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 24 hours post dose 
 
Secondary Outcome  
Outcome  TimePoints 
Time interval between onset of pain relief and the need for second application of test product for pain relief [Time frame: 0-24 hours]
Subject’s overall satisfaction for pain relief on a 7- point Likert Satisfaction scale [Time Frame: Day 1 to Day 10 post dose]
User perception will be assessed with a 5- point Likert Satisfaction scale on the following points:
1. Ease of application, 2. Stickiness 3. Greasiness and 4. Ease of spreading. [Time Frame: Day 1 to Day 10 post dose]
Number of patients requiring rescue medication [Time Frame: Day 1 to Day 10 post dose]
To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire.
 		 Day 1 to Day 10 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) 25/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study selected participants (24 subjects) will receive treatment as follows: Test arm 1 : (musculoskeletal pain) Amrutanjan advanced joint muscle + spray 24 subjects. The study participants will be requested to hold the spray device 6 inches away from the affected area and spray 3 to 4 times a day. If they have no relief after 2 hrs of spray application, they were permitted to use rescue medications. The participant will be asked to visit clinical facility/institution for their follow up visits on day 2 and day 10 
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