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A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle

CompletedNot applicableNCT04980469
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Clinical trial will study the effect of a formulation containing Vitex negundo leaf extract and Zingiber officinale extract on alleviating chronic low back pain and related disability in individuals leading a sedentary lifestyle. It will also evaluate the efficacy of the product on other factors associated with LBP, including mobility, work productivity and sleep quality.

Study details

Official title
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
Conditions
Interventions
  • Other: Vitex negundo + Zingiber officinale
  • Other: Placebo (MCC)
Sponsor
Vedic Lifesciences Pvt. Ltd.
Start date
2021-09-25
Primary completion
2022-02-07
Sex
All
Age range
from 18 Years to 60 Years
Results posted
No results posted in this snapshot
Countries
India
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 d…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04980469