Effect of CL20192 in subjects with chronic low back pai

Not Applicable

Completed

Conditions: Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Registration Number: CTRI/2021/03/031709

Lead Sponsor: CLS Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Ambulatory, male and female subjects aged between 21 and 60 years with a Body Mass Index of approximately 20 to 29 kg per square meter.

Subjects show normal spinal and pelvic alignments in Digital X-ray.

Subjects with nonspecific low back pain primarily in the lumbar region below the costal margin and above the gluteal folds present on a daily basis for the previous 12 weeks or longer, adjectivally described as, of at least moderate intensity Score 4 to 6 on a 0 to 10 Numeric Rating Scale and having an impact on two or more aspects of everyday life.

Subjects had experienced an acute episode or multiple episodes of LBP during last one year.

Subjects agreed to abstain from medication-oral, injections or topical or related therapies massage, cold wave, heat therapy etc which are not a part in this study.

Subjects who can remain stable on use of NSAIDS.

Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.

Results of screening are within normal range or considered not clinically significant by the Principal Investigator.

Agree to participate in the study through a written informed consent.

Exclusion Criteria

Subjects who qualified in the physical exam-A specific back exam that includes inspection for scars, spinal alignment and posture, palpation for point tenderness, spinal alignment and pelvic alignment, range of motion of the back, hip, knee and ankle, strength of the hip, knee, ankle, including heel or toe walking, sensation test for light touch and pin prick, patellar and Achilles reflexes, and a straight leg raise.

Subjects underwent treatment for COVID 19 or tested positive during the study will be excluded.

Significant coexisting orthopedic or pain problems or back pain due to other disorders eg, True sciatica, Fibromyalgia, vertebral fracture, osteomyelitis, metastatic cancer, rheumatoid arthritis, and spinal stenosis. Subjects with known or suspected serious pathology as the cause of back pain e.g. fracture, cancer, infection, inflammatory arthritis, cauda equine, disc prolapse, spondylolisthesis, osteomalacia, or inflammatory arthritis.

Expectation of any surgery during the study period.

A major coexisting medical illness e.g., diabetes, renal or hepatic disease, chronic obstructive pulmonary disease, cancer, or class III or IV organic heart disease or major surgical or non-surgical intervention for any disorder within the past 12 months.

Subjects with history of immune system and autoimmune disorders.

Subjects with Tuberculosis of spine, Metal implants in vertebra and with severe Osteoporosis.

Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period.

Subjects have a suspected hypersensitivity, allergy or sensitivity to herbal products.

History of congestive heart failure or any vascular conditions.

Subjects using anti-depressants and other anti-psychotic medications.

Subjects with HIV Positive status.

Evidence or history of clinically significant-in the judgment of the Investigator hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, thyroid disease.

Subjects consuming alcohol or smokers and other drug of abuse-narcotics.

History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.

Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.

Subjects willing to refrain from the pain killers other than prescribed NSAIDS within 7 days prior to the Screening Visit-Visit 1.

History of heart, liver, lung cancer or chronic diseases.

Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to the end of the study period in Score of transformed descriptor differential scale (DDS) -Pain intensity adjusted for timeTimepoint: Day 1, 30, 60 and 90

Secondary Outcome Measures

Name	Time	Method
Change at end of the study period in Phytochemical markers in serumTimepoint: Day 90;Change from baseline to end of the study period in Physician and patient global assessment scaleTimepoint: Day 1, 30, 60 and 90;Change from baseline to the end of the study period in Oswestry low back pain and disability questionnaireTimepoint: Day 1, 30, 60 and 90;Change from baseline to the end of the study period in Quality of life questionnaire (SF-36)Timepoint: Day 1, 30, 60 and 90;Change from baseline to the end of the study period in Serum biomarkersTimepoint: Day 1 and 90;Change from baseline to the end of the study period in Frequency of Pain Killer UsageTimepoint: Day 1, 30, 60 and 90