| CTRI Number |
CTRI/2014/07/004797 [Registered on: 31/07/2014] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of an Indian frankincense extract ointment in patients with Chronic low back ache compared to Placebo ointment. |
|
Scientific Title of Study
|
A Multicentric Randomized, Double Blind, Placebo Controlled Comparative Pilot Human Clinical Study to Assess the Efficacy and Tolerability of a Boswellia Serrata Extract Ointment in Patients with Chronic Low Back Ache |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-01BSO 0813H1-CRF02,Version 01 dated 02/08/2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BinuTKuruvilla |
| Designation |
Overall Trial Co-ordinator |
| Affiliation |
Arjuna Natural Extracts Limited |
| Address |
AGM R&D,
Arjuna Natural Extracts Limited
P.B.No.126, Bank Road, Alwaye
Ernakulam
KERALA
683 101
India |
| Phone |
0484-2542480 |
| Fax |
|
| Email |
lab@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BinuTKuruvilla |
| Designation |
Assistant General Manager R&D |
| Affiliation |
Arjuna Natural Extracts Limited |
| Address |
Arjuna Natural Extracts Limited
P.B.No.126, Bank Road, Alwaye
Ernakulam
KERALA
683101
India |
| Phone |
0484-2542480 |
| Fax |
|
| Email |
lab@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreejith Sreekumar |
| Designation |
Chief Executive Officer |
| Affiliation |
Clinfound Clinical Research Services Pvt Ltd |
| Address |
Clinfound Clinical Research Services Pvt Ltd
832 C1, AR3 Annexe
Seaport Airport Road,
Near Vallathol Jn
Thrikkakara, Cochin
Ernakulam
KERALA
682021
India |
| Phone |
0484-606-2400 |
| Fax |
|
| Email |
drsreejith@clinfound.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Extracts Limited
P.B.No.126, Bank Road, Alwaye – 683 101
|
|
|
Primary Sponsor
|
| Name |
Clinfound Clinical Research Services PvtLtd |
| Address |
Seaport Airport Road, Thrikkakara, Cochin - 682021
|
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KBalakondaiah MSOrtho |
Bollineni Superspeciality Hospital |
Dr. K.Balakondaiah, MS(Ortho)
Consultant Orthopaedic Surgeon Bollineni Superspeciality Hospital, Dargamitta,
Nellore - 524003
Andhra Pradesh,
Nellore
ANDHRA PRADESH |
91-9440279700
bakolaxmi@rediffmail.com |
| Dr Vinod Kumar Pavithran |
KVM Multispeciality Hospita |
Dr. Vinod Kumar Pavithran
Consultant General Physician
KVM Multispeciality Hospital
P.B:No.30,Cherthala,Alappuzha-688524
Alappuzha
KERALA |
0989519302
drvinodmd@gmail.com |
| Dr Renu Dixit MDAyu |
Swastha Ayurvedic Clinic |
Dr. Renu Dixit, MD(Ayu)
Asst. Prof Dept of Dryavya guna SV Ayurvedic College, Tirupati
Swastha Ayurvedic Clinic,121-D
Ramulavari,South Mada Street,Tirupati-517501
Chittoor
ANDHRA PRADESH |
0877-2220534
drrenudixit@gmail.com |
| DrPrasad MAVV MSOrtho |
Vijaya Superspeciality Hospital |
Dr.Prasad MA.V.V, MS(Ortho)
Consultant Orthopaedic Surgeon
Vijaya Superspeciality Hospital,
Ragahava Cini-complex,Pogathotta
SPSR,Nellore- 524 001
Nellore
ANDHRA PRADESH |
0861-2321828
mavvprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| KVM Hospital Institutional Ethics Committee, Cherthala,Kerala |
Approved |
| Simhapuri Independent Ethics Committee, Nellore, Andhra Pradesh |
Approved |
| Simhapuri Independent Ethics Committee, Nellore, Andhra Pradesh |
Approved |
| Simhapuri Independent Ethics Committee, Nellore, Andhra Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with low back pain for at least 3 months, (1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boswellia Serrata Extract Ointment applied to low back as External Application TID for 14 days. Subjects will be asked to take the ointment in the palm and spread over the
entire affected area with ointment 3 times daily (8 hourly |
It is Provided by Arjuna Natural Extracts Limited,Aluva.
|
| Comparator Agent |
Placebo Ointment External Application TID for 14 days
Subjects will be asked to take the ointment in the palm and spread over the
entire affected area with ointment 3 times daily (8 hourly
|
Placebo ointment will have
the same appearance, shape, color and packaging as that of the investigative product. It will be provided by Arjuna Natural Extracts Limited,Aluva |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with low back pain for at least 3 months and assessed on the Quebec Task Force system on Spinal Disorders as either
•Class 1 (pain without radiation to an extremity and without neurological signs) or
•Class 2 (pain with radiation to an extremity, but not below the knee and without neurological signs)
3.Patients with a pain score > 4 on visual analog scale (VAS) in the low back region at the time of randomization
4.Patients ready to give written informed consent and willing to comply the study protocol
|
|
| ExclusionCriteria |
| Details |
1.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
2.Patients with specific causes of back pain (i.e. disc prolapse, spondylolisthesis, ischialgia, spinal stenosis), instability of the spine, spinal fractures, tumors, infections and inflammatory disorders, cervical spine syndrome or osteoporosis ,rheumatoid arthritis, Lyme’s arthritis, rheumatic factors >40 IU/L, seronegative spondyloarthropathies including ankylosing spondylitis, or neurologic etiology (i.e., radiculopathy, neuropathy, myelopathy)
3.Surgery for low back pain in the last 6 months or planning for surgical intervention during the course of the study.
4.Use of acetaminophen in last 12 hours; or any other systemic or topical analgesics, muscle relaxants in the last 7 days; and corticosteroids or nerve blocks in the past 4 weeks of randomization
5.Known hypersensitivity or intolerance or allergic type reactions to Boswellia or acetaminophen
6.History of known alcohol, analgesic or narcotic abuse within 2 years.
7.Sensitive skin and loss of skin at the application site.
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
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in VAS score of pain experienced at end of study as compared to baseline. |
Baseline, Day 7, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Modified Oswestry low back pain disability index score at end of study as compared to baseline |
Baseline, Day 7, Day 14 |
| Arthus Pain score (sum of current pain, average pain in last week and worst pain in last week) at the end of study |
Baseline, Day 7, Day 14 |
| Pain relief score at the end of study |
Baseline, Day 7, Day 14 |
| Patients and investigators overall assessment |
Baseline, Day 7, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/08/2014 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
The results will be published in international journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a randomized, double blind, parallel group, placebo controlled
multi-centre Pilot trial comparing the efficacy and Tolerability of a Boswellia
Serrata Extract Ointment in Patients with Chronic Low Back Ache in comparison
with placebo ointment daily on three times daily dosage for 14 days in 140
patients with chronic low back ache that will be conducted in five centers in
India. The primary outcome measures will be Change in Visual Analogue Scale
score of pain experienced at end of study as compared to baseline. The secondary outcomes
will be Change
in Modified Oswestry low back pain disability index score at end of study as
compared to baseline, Arthus Pain score (sum of current pain, average pain in
last week and worst pain in last week) at the end of study, Pain relief score
at the end of study and Patient’s and investigators overall assessment. |