A clinical trial to study the effects of an Indian frankincense extract ointment in patients with Chronic low back ache compared to Placebo ointment.

Suspended

• Conditions: Unspecified soft tissue disorder related to use, overuse and pressure,

• Registration Number: CTRI/2014/07/004797
• Lead Sponsor: Clinfound Clinical Research Services PvtLtd

Brief Summary

Thisstudy is a randomized, double blind, parallel group, placebo controlledmulti-centre Pilot trial comparing the efficacy and Tolerability of a BoswelliaSerrata Extract Ointment in Patients with Chronic Low Back Ache in comparisonwith placebo ointment daily on three times daily dosage for 14 days in 140patients with chronic low back ache that will be conducted in five centers inIndia. The primary outcome measures will be Change in Visual Analogue Scalescore of pain experienced at end of study as compared to baseline. The secondary outcomeswill be Changein Modified Oswestry low back pain disability index score at end of study ascompared to baseline, Arthus Pain score (sum of current pain, average pain inlast week and worst pain in last week) at the end of study, Pain relief scoreat the end of study and Patient’s and investigators overall assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-08
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VAS score of pain experienced at end of study as compared to baseline.	Baseline, Day 7, Day 14

Secondary Outcome Measures

Name	Time	Method
Change in Modified Oswestry low back pain disability index score at end of study as compared to baseline	Baseline, Day 7, Day 14
Pain relief score at the end of study	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
Patients and investigators overall assessment	Baseline, Day 7, Day 14

Trial Locations

Locations (4)

Bollineni Superspeciality Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

KVM Multispeciality Hospita; 🇮🇳 Alappuzha, KERALA, India

Swastha Ayurvedic Clinic; 🇮🇳 Chittoor, ANDHRA PRADESH, India

Vijaya Superspeciality Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Bollineni Superspeciality Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr KBalakondaiah MSOrtho

Principal investigator

91-9440279700

bakolaxmi@rediffmail.com