Clinical trial NCT04980469: A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, Placebo controlled, Parallel group
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Vitex negundo is a large aromatic shrub or tree part of the family Lamiaceae. Many parts of the plant have been studied for their medicinal properties, as they contain phytochemicals and secondary metabolites in the plant leaves, roots, flowers, and seeds.

These bioactive compounds are the reason behind the plant's anti-inflammatory, antihistamine, anti-diabetic, anti-oxidant, anti-cancer and antimicrobial activity. In a study wherein the plant leaf extract was fed to rats, it revealed the pain relieving properties of the fresh Vitex negundo leaves, which could be mediated by prostaglandin synthesis inhibition. However, there are no clinical trials that use the plant for chronic low back pain relief. On the other hand, Zingiber officinale (ginger) is a part of the family Zingiberacae and is one of the most important medicinal plants in use today. It has been used for pain relief in both oral and topical forms. It has been used in clinical trials to alleviate pain during dysmenorrhea, muscle soreness, osteoarthritis and chronic low back pain. However, in the clinical trial studying its effect on chronic low back pain, ginger was used in the form of an aromatic oil.The use of both these extracts in all the studies mentioned saw minimal problems related to toxicity and are seen as safe for consumption without any harmful effects, especially due to their use in traditional medicine. It has been stated however that extremely high dosage of ginger could lead to gastrointestinal discomfort, central nervous system depression, allergic reactions, prolonged pre-existing bleeding, and arrhythmia.Therefore, this 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.

The present study is 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. Approximately 90 participants aged between ≥ 18 and ≤ 60 years will be screened. Both the IP and placebo trial arms will have atleast 30 completed participants after accounting for the screening failure and dropout/withdrawal rate of 20% each. The treatment duration for all the study participants will be 30 days.

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\&#39;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.

Primary outcomes:
measure: Roland Morris Questionnaire
timeFrame: Days 0, Day 7 and Day 30.
Secondary outcomes:
measure: Fingertip-to-Floor Test
timeFrame: Days 0,and 30.
measure: Pain Visual Analogue Scale
timeFrame: Days 0, 7 and 30.
measure: Work Productivity and Activity Impairment Questionnaire
timeFrame: Days 0,and 30.
measure: Insomnia severity index
timeFrame: Days 0,and 30.
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dr. Adkar clinic
state: Maharashtra
city: Mumbai
country: India
facility: Shree Polyclinic
state: Maharashtra
Study officials:
References: