| CTRI Number |
CTRI/2018/03/012822 [Registered on: 26/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/03/2018 |
| 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 to evaluate the efficacy and safety of Lower Back Comfort in patients with Lower Back Ache |
|
Scientific Title of Study
|
A prospective, multi center, randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of Lower Back Comfort in patients with Lower Back Ache. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPL/57/WBC/MAR/17.Version: 1.0,Date: 06-MAR-17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mithran |
| Designation |
Orthopedician |
| Affiliation |
Muthu Hospital |
| Address |
Muthu Hospital
No.11,Krishna Rao Tank, Street,
MaduraI
Madurai
TAMIL NADU
625001
India |
| Phone |
|
| Fax |
|
| Email |
drmithran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Subramanian Jagadeesan |
| Designation |
Sr.Manager |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2,I Main,II Phase,Peenya Industrial Area,Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
|
| Fax |
|
| Email |
sjagadeesan@clinworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Mr Subramanian Jagadeesan |
| Designation |
Sr.Manager |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2,I Main,II Phase,Peenya Industrial Area,Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
|
| Fax |
|
| Email |
sjagadeesan@clinworld.org |
|
|
Source of Monetary or Material Support
|
| Sami Labs Limited
19/1, 19/2, 1st Main, 2nd Phase, Peenya Industrial Area, Bengaluru, Karnataka 560058 |
|
|
Primary Sponsor
|
| Name |
Sami Labs Limited |
| Address |
19/1 & 19/2, I Main,II Phase, Peenya Industrial Area,Bangalore, Karnataka.560058. |
| Type of Sponsor |
Other [Marketer & manufactuer of phytonutrients,ayurvedic,herbal extracts,probiotics etc.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mithran |
Muthu Hospital |
Orthopaedic Department,
Room No.11,
Krishna Rao Tank Street
Madurai-625001
Madurai
TAMIL NADU |
9894782428
drmithran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Radianz Health Care & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lower Back Ache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lower Back Comfort Capsules |
Orally twice a day for 30 days. |
| Comparator Agent |
Placebo capsules |
Orally twice a day for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy adult volunteers with clinical symptoms of low back ache with no other clinical condition.
2 Willing to sign on Informed consent form.
3 Patients with low back pain that was not attributable to any identifiable cause, such as disc prolapse, spondylolisthesis, osteomalacia or inflammatory arthritis. |
|
| ExclusionCriteria |
| Details |
1 Patients with established hypertension, renal, hepatic or cardiac failure, on long-term steroid treatment.
2 Patients suffering from autoimmune disorder; spastic condition or genetic disorders.
3 Non-adherence to the treatment.
4 History of any other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study.
5 Low back pain of Class 3 (pain with radiation distally beyond the knee and without neurologic signs) or Class 4 (Pain with radiation to the extremity and with neurologic signs) classified by the Quebec Task Force Classification for Spinal Disorders.
6 Patients with specific causes of back pain (i.e. disc prolapse, spondylolisthesis, ischialgia, spinal stenosis), instability of the spine, spinal fractures, tumours, infections and inflammatory disorders, cervical spine syndrome or osteoporosis ,rheumatoid arthritis.
7 Known hypersensitivity or intolerance to investigational products.
8 Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential.
9 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
|
| Outcome |
TimePoints |
1 Visual Analogue Scale
2 Owestry Disability Questionnaire.
3 Fingertip-to-Floor Test.
4 Patients and investigators overall assessment.
5 C - reactive protein and Erythrocyte sedimentation rate.
6 Haemogram and Liver Function Test and Renal Function Test |
1 VAS(Screening,Day15 and Day30)
2Questionnaire(Screening,Day15 and Day30)
3 Fingertip-to-Floor Test(Screening,Day15 and Day30).
4 Patients and investigators overall assessment(Screening,Day15 and Day30).
5 CRP and ESR(Day0 & Day30).
6 Blood Tests(Day0 & Day30). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety of Lower Back Comfort in patients with lower back ache.
Safety Outcomes
Clinical Safety
• Global Assessment of Tolerability to Therapy [GATT] on a 5-point scale.
• Incidence of the adverse events.
• Laboratory Safety
|
Screening to end of the treatment |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2017 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective,multi center, randomized, double blind, placebo controlled study will be conducted in 84 male or female adult human volunteers in the age group of 18 to 70 years with clinical symptoms of low back ache. The individual subject participation will be for 30 days. The efficacy outcomes for the study would be change in Visual analogue scale, Owestry Disability Questionnaire, Fingertip-to-Floor Test, Patients and Investigators overall assessment and biomarkers. Safety outcomes include Global Assessment of Tolerability to therapy , adverse events, laboratory parameters. Statistical analysis will be performed as listed in the protocol.
|