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

Not Applicable

Suspended

• Conditions: Health Condition 1: null- Patients with low back pain for at least 3 monthsHealth Condition 2: M709- 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

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• 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, Lymeâ??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 patientâ??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