| CTRI Number |
CTRI/2023/07/055120 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
09/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Turmeric-boswellia extract in subjects with low back discomfort. |
|
Scientific Title of Study
|
A randomized double-blinded placebo-controlled study to determine the efficacy of Turmeric-Boswellia formulation on subjects with low back soreness and discomfort. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-06PFK0623H3-WES15 version 1, date 1 Jun 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Sooraj Rajasekharan Kartha |
| Designation |
Scientist- Clinical Research |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam
Ernakulam
KERALA
683101
India |
| Phone |
9847670997 |
| Fax |
|
| Email |
sooraj@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt Ltd
Bank Road, Aluva Ernakulam 683101 KERALA |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam KERALA |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
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 Ajay Gupta |
Nirmal Hospital |
Dept of orthopedics,
OPD Room no: 1, Ground Floor,
Opp MLB Medical college,
Gate no. 3
Jhansi
UTTAR PRADESH |
9005665599
ajaygupt70@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nirmal Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posture related low back discomfort |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
polysorbate-80 and PEG400 in 500mg soft gel capsules once daily for 15 days. |
| Intervention |
Turmeric-Boswellia extract |
Turmeric-Boswellia extract in sesame oil 500mg soft gel capsules once daily for 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male or female 18 to 70 years of age
Posture related low back pain
NRS score greater than 5 pain at the time of screening.
BMI 18 to 29kg/m2 |
|
| ExclusionCriteria |
| Details |
History of herniated or ruptured disc, Sciatica, inflammatory arthropathy, severe rheumatoid arthritis, severe osteoarthritis, fibromyalgia, gout, kidney infection, failure or stones, scoliosis or spondylolisthesis, Past injuries like fractures, tears or trauma to the spine, and tumour or spinal cancer.
Acute 48-hour pain due to some exercise.
Knee surgery within the past 6 months, expectations of surgery in the next 4 months, Intra-articular corticosteroid injections within the preceding 3 months.
No neurological symptoms like numbness or weakness in the legs. Muscle pain does not involve compression or irritation of the spinal nerves.
BMI greater or eqaul to 30
High alcohol intake greater than 2 standard drinks per day
Smoking status not more than 1 pack per day
Concomitant medications antibiotics, NSAIDS, steroids, OTC pills and ointments for pain 1 week before screening. Patients taking any joint pain supplements
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in the Sum of pain intensity difference at 6 hours |
Day 1, 7, 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in Total pain relief at 6 hours |
Day 1, 7, 15 |
| Mean change in Oswestry Disability Index |
Day 1, 7, 15 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/07/2023 |
| 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)
|
Completed |
| 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
|
The lower back is one of the most affected part in the
posture related pain associated with work/lifestyle habits. This is different
from the acute pain originating from exercise which arises within 48 hours. The
lower back pain from posture starts mildly and progresses to moderate to severe
pain and lasts for weeks or till the posture or lifestyle is changed. Turmeric-boswellia
extract has excellent pain reliving properties and this study looks to
determine its pain relieving properties in low back soreness and discomfort
caused by posture. This study includes subjects having pain for at least last
2-3 weeks having an NRS score of greater than or equal to 5 at the time of
screening. This study excludes disc related and lower limb related pain and
other systemic illnesses. A mean change in the SPID at 6hrs is the primary end
point and the study duration is of 15 days.
|