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

NCT04980469 | Completed

• 1 other identifier: EB/210402/VT/LBP
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Roland Morris Questionnaire

  To determine effect of 30 days administration of IP on functional activities due to low back pain as assessed by the change in Roland-Morris disability score from baseline as compared to the change in placebo. The scale is used to differentiate between patients who have chronic low back pain without any form of disability and those who experience some form of disability due to the pain experienced. Only participants with a Roland Morris disability score between ≥ 8 and ≤ 15 will be included in the study, to exclude individuals with minimal and extremely debilitating chronic low back pain.

  Days 0, Day 7 and Day 30.

Secondary Outcomes (4)

• Fingertip-to-Floor Test

  Days 0,and 30.

• Pain Visual Analogue Scale

  Days 0, 7 and 30.

• Work Productivity and Activity Impairment Questionnaire

  Days 0,and 30.

• Insomnia severity index

  Days 0,and 30.

Study Arms (2)

Vitex negundo + Zingiber officinale

EXPERIMENTAL

Dosage: 200 mg/ Capsule;1 capsule twice daily Route: Oral

Other: Vitex negundo + Zingiber officinale

Placebo (MCC)

PLACEBO COMPARATOR

Dosage: 200 mg/ Capsule; 1 capsule twice daily Route: Oral

Other: Placebo (MCC)

Interventions

Vitex negundo + Zingiber officinale OTHER

200 mg/ Capsule

Vitex negundo + Zingiber officinale

Placebo (MCC) OTHER

200 mg/ Capsule

Placebo (MCC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 18 and 60 years old
• Participants with a history of sub-acute low back pain with symptoms continuously persisting since ≥ 7 and ≤ 12 weeks.
• 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.
• Participants who have a Roland-Morris disability score between ≥ 8 and ≤ 15.
• Participants with a Body mass index ≥ 20 and ≤ 35 kg/m 2 .
• Participants with FBG ≤ 110 mg/ dl
• Participants with TSH ≥0.40 and ≤ 4.2 mIU/L
• 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.
• Participants who have given their signed Informed Consent.

You may not qualify if:

• Participants currently undergoing treatment with analgesics of chemical (NSAIDS), animal or herbal origins
• Participants currently undergoing treatment with any other muscle relaxant or any drugs having muscle relaxant properties
• Participants with history suggesting off and on symptoms of low back pain since more than 12 months.
• 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).
• Individuals with history of hyperacidity with atleast one episode/ week.
• 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.
• Women who have undergone menopause i.e. Post- menopausal women
• Participants with uncontrolled hypertension defined as systolic blood pressure ≥ 129 and/or diastolic blood pressure ≥ 89 mm Hg
• Individuals with diagnosed cases of migraine
• Participants who had spinal surgery within 1 year of study entry
• Participants who have used steroids within 3 months of study entry or any other long-term treatment with steroids
• Individuals with history of hypnotics use or other CNS depressants.
• Participants with history of lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis
• Participants who have severe scoliosis
• Participants with more severe pain in a region other than the lower back

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (2)

Dr. Adkar clinic

Mumbai, Maharashtra, 400067, India

Location

Shree Polyclinic

Mumbai, Maharashtra, 400067, India

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo controlled, Parallel group

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 28, 2021
• Study Start: September 25, 2021
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

IN (2)