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CTRI Number  CTRI/2019/12/022519 [Registered on: 26/12/2019] Trial Registered Prospectively
Last Modified On: 22/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Clinical trial on back pain on their sleep quality 
Scientific Title of Study   An open label, single arm observational study to evaluate Solimo orthopaedic memory foam mattress relative influence on subjects with mild to chronic back pain on their sleep quality, activities of daily living”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/AMZ/MF/2019 Version 1.0 Dated 25th November 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi  
Designation  Director 
Affiliation  Radiant Research Services Pvt. Ltd  
Address  Radiant Research Services Pvt. Ltd Clinical Division, Room No-02 #99/A, 8 Main, III Phase Peenya Industrial Area, Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  09880999297   
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi  
Designation  Director 
Affiliation  Radiant Research Services Pvt. Ltd  
Address  Radiant Research Services Pvt. Ltd Clinical Division, Room No-02 #99/A, 8 Main, III Phase Peenya Industrial Area, Bangalore


KARNATAKA
560058
India 
Phone  09880999297   
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Public Query  
Name  Mr Praveen ME  
Designation  Sr. Product Compliance Manager 
Affiliation  Amazon Development Centre (India) Pvt. Ltd 
Address  No.26/1, Brigade Gateway, 8th, 9th & 10th Floor, Dr Rajkumar Road, Bangalore - 560055

Bangalore
KARNATAKA
560055
India 
Phone  9036777314  
Fax    
Email  prvm@amazon.com  
 
Source of Monetary or Material Support  
Amazon Development Centre (India) Pvt. Ltd No.26/1, Brigade Gateway, 8th, 9th & 10th Floor, Dr Rajkumar Road, Bangalore - 560055  
 
Primary Sponsor  
Name  Amazon Development Centre India Pvt Ltd 
Address  No.26/1, Brigade Gateway, 8th, 9th & 10th Floor, Dr Rajkumar Road, Bangalore - 560055 
Type of Sponsor  Other [E commerce 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 Srinivas P  Shettys Hospital  Room number 4 Ground floor Department of orthopedic Plot No, 11 & 12, 12th F Main Rd, Kaveri Nagar, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA 		 9164245208

shettyshospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shettys hospital Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Male and Female subjects’ in general good health.
2.Subjects in the age group 18-60 years (both the ages inclusive).
3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
4.Subjects willing to abide by and comply with the study protocol.
5.Subjects who have not participated in a similar investigation in the past four weeks.
6.Healthy volunteers with no known allergy to any of the test ingredients as established by medical history
 
 
ExclusionCriteria 
Details  1.Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors, and any other analgesic medicine.
2.Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test
3.Non degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of bone and joint health (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection)
4.Subjects incapacitated or bound to wheel chair or bed and unable to carry out self-care activities
5.Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study.
6.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine
7.Presence or history of active peptic ulcer in the preceding 6 months or bleeding ulcer at any time in the past.
8. Evidence of several renal, hepatic or hemopoiic disease or severe cardiac insufficiency as revealed by laboratory investigations.
9.Subjects with congestive heart failure
10.Subjects with hypertension
11.Clinically significant untreated hyperlipidaemia in context of a cardiovascular risk
12.History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing.
13.Concurrent pain relieving medication such as antipyretics, analgesic, tranquilizers, hypnotics, excessive alcohol, NSAIDs, (Paracetamol & Tramadol are permitted in extreme pain) which would interfere with pain perception
14.Non-co-operative attitude of the volunteer
15.Any condition that in the opinion of the investigator does not justify the volunteer’s inclusion for the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluating the sleep quality by standard questionnaire (Sleep Quality Index)
• Evaluating the quality of activities of daily living by standard questionnaire (SF-6 questionnaire).
• Evaluation of severity of the back pain (SF-MPQ-2).
 		 Day 0 to Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1.Evaluation of the product acceptance by the subjects for the regular use through a questionnaire.
2.Assessment for adverse events
 		 Day 0 to Day 28 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/12/2019 
Date of Study Completion (India) Date Missing 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Back pain is the most common type of chronic pain problem, and is the most common medical disorder in industrialized societies. Back pain is also the chief cause of disability among those younger than 45

This study is to evaluate the impact in sleep quality and musculoskeletal pain of a Solimo orthopaedic memory foam mattress, and their relationship with objective sleep parameters in a group of adults with mild to chronic back pain.


 
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