Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT04980469
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged between 18 and 60 years old
2. Participants with a history of sub-acute low back pain with symptoms continuously persisting since ≥ 7 and ≤ 12 weeks.
3. Participants with pain of moderate to severe intensity (≥ 60 mm in the VAS) in the area between the 12 th ribs and the buttock creases.
4. Participants who have a Roland-Morris disability score between ≥ 8 and ≤ 15.
5. Participants with a Body mass index ≥ 20 and ≤ 35 kg/m 2 .
6. Participants with FBG ≤ 110 mg/ dl
7. Participants with TSH ≥0.40 and ≤ 4.2 mIU/L
8. Individuals physically inactive for ≥1/3 rd of wake time (barring only night sleep time), as determined using the Longitudinal Aging Study Amsterdam (LASA) sedentary behaviour questionnaire.
9. Participants who have given their signed Informed Consent.
Exclusion Criteria:
1. Participants currently undergoing treatment with analgesics of chemical (NSAIDS), animal or herbal origins
2. Participants currently undergoing treatment with any other muscle relaxant or any drugs having muscle relaxant properties
3. Participants with history suggesting off and on symptoms of low back pain since more than 12 months.
4. Individuals with history of structured physical exercise for ≥2 days/ week (includes but not limited to walking, jogging running, yoga or any other form of exercise).
5. Individuals with history of hyperacidity with atleast one episode/ week.
6. Participants with evidence of a clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator\'s/medical monitor's opinion, preclude entry into the study.
7. Women who have undergone menopause i.e. Post- menopausal women
8. Participants with uncontrolled hypertension defined as systolic blood pressure ≥ 129 and/or diastolic blood pressure ≥ 89 mm Hg
9. Individuals with diagnosed cases of migraine
10. Participants who had spinal surgery within 1 year of study entry
11. Participants who have used steroids within 3 months of study entry or any other long-term treatment with steroids
12. Individuals with history of hypnotics use or other CNS depressants.
13. Participants with history of lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis
14. Participants who have severe scoliosis
15. Participants with more severe pain in a region other than the lower back
16. Participants with acute low back pain associated with chills or fever
17. Participants who are pregnant/breast feeding or are planning to get pregnant during the course of the study.
18. Individuals who have receives treatment with another investigational agent within the last 30 days.
19. Participants with known or suspected history of alcohol ordrug abuse based on medical history, physical examination, or the Investigators clinical judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04980469
Study Brief:
Protocol Section:
NCT04980469