study on low back pai
- Conditions
- Health Condition 1: null- Symptomatic with acute low back pain, with or withoutradiating pain no lower than the knee, for less than 3 days.
- Registration Number
- CTRI/2016/10/007348
- Lead Sponsor
- Dr Reddys Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient of either sex between 18 to 60 years of age
2. Symptomatic with acute low back pain, with or without
radiating pain no lower than the knee, for less than 3 days
3. Patients willing to take the medications as directed and
willing to come for the follow-ups
4. Willing to comply with the protocol requirements
5. Willing to give the written informed consent
1. Patients associated with other lumbar or cervical spinal
tract conditions such as spondylitis, fracture, cancers, severe
arthritis and osteoporosis.
2. Muscular diseases such as myositis, poliomyositis, muscular
dystrophy and myotonia.
3. Other known systemic diseases affecting the neurological or
endocrine system.
4. Patients with moderate to severe hepatic impairment
(defined as increase in serum bilirubin, SGOT & SGPT by
>2.5 times the upper reference level of the laboratory
values) and renal impairment (defined as increase in serum
creatinine and Blood urea nitrogen by >2.5 times the upper
reference level of the laboratory values).
5. Patients who had taken any form of skeletal muscle relaxant
in the previous 48 hours (2 days).
6. Pregnant / Lactating Woman or women of child bearing
potential not following adequate contraceptive measures.
7. Patients with known hypersensitivity to ingredients of
study/active comparators.
8. Patients with any previous H/O or current episode of cardiovascular
disorders.
9. Subject known to be having any of the following disorder:
Renal failure, Bulimia, Hypo and hyperthyroidism,
Nephrotic Syndrome, Anorexia nervosa, biliary obstruction,
severe cardiac dysfunction.
10. Uncontrolled diabetes mellitus or any other metabolic
disorder.
11. Patients with H/O alcohol of substance abuse.
12. Treatment with any investigational drug in the preceding 4
weeks.
13. Patients with active or recent history of, inflammatory
diseases of the gastrointestinal tract such as peptic ulcer,
gastritis, regional enteritis, or ulcerative colitis.
14. Patients in whom Acetyl Salicylic Acid (ASA) or other nonsteroidal
anti-inflammatory agents (NSAIDs) have induced
asthma, rhinitis, urticaria or other allergic manifestations.
15. Any other condition that, in the opinion of the investigator,
does not justify the inclusion of the subject in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method