Back to resultsA Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Vitex negundo + Zingiber officinale
Placebo (MCC)
Sponsored by
About this trial
This is an interventional other trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Participants with acute low back pain associated with chills or fever
- Participants who are pregnant/breast feeding or are planning to get pregnant during the course of the study.
- Individuals who have receives treatment with another investigational agent within the last 30 days.
- Participants with known or suspected history of alcohol ordrug abuse based on medical history, physical examination, or the Investigators clinical judgment.
Sites / Locations
- Dr. Adkar clinic
- Shree Polyclinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitex negundo + Zingiber officinale
Placebo (MCC)
Arm Description
Dosage: 200 mg/ Capsule;1 capsule twice daily Route: Oral
Dosage: 200 mg/ Capsule; 1 capsule twice daily Route: Oral
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Fingertip-to-Floor Test
Using this test, the forward bending flexibility and mobility of individuals with chronic low back pain will be assessed, as well as the impact of IP consumption on the same in comparison to placebo. Participants will be asked to bend forward and attempt to touch the floor with their fingertips. The investigator will then measure the distance between the floor and the participant's right long finger using a standard measuring tape. The difference in height between the floor and the participant's right long finger will be compared from baseline to Day 30, and in comparison to the placebo
Pain Visual Analogue Scale
Participants will be asked to recall the pain they experienced in the specified lower back region, after which they will be asked to mark a point on the 100-point visual analogue scale that corresponds to the level of pain experienced. Participants will have to self-administer the scale.
minimum score 0 is referred to no pain at all and Maximum Score 100 is referred to as the worst possible pain
Work Productivity and Activity Impairment Questionnaire
Chronic low back pain has been associated with lower work productivity in several studies. Using the Work Productivity and Activity Impairment Questionnaire, the impact of chronic low back pain on work and the performance of regular activities will be studied. The questionnaire consists of six questions, all the replies being categorized into 4 groups: 1) Percentage worktime missed, 2) Percentage impairment while working, 3) Percentage overall work impairment and 4) Percentage activity impairment.
Insomnia severity index
Participants will be asked to recall their sleep patterns for the past month and then fill the aforementioned questionnaire on baseline and Day 30. In this study, the Change of insomnia severity due to chronic low back pain will be studied throughout the study duration from baseline and in comparison to placebo.
The score ranges for the same are as follows:
0-7: No clinically significant insomnia 8-14: Subthreshold insomnia 15-21: Clinical insomnia (moderate severity) 22-28: Clinical insomnia (severe)
Full Information
NCT ID
NCT04980469
First Posted
July 14, 2021
Last Updated
April 18, 2022
Sponsor
Vedic Lifesciences Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04980469
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2021 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Placebo controlled, Parallel group
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitex negundo + Zingiber officinale
Arm Type
Experimental
Arm Description
Dosage: 200 mg/ Capsule;1 capsule twice daily Route: Oral
Arm Title
Placebo (MCC)
Arm Type
Placebo Comparator
Arm Description
Dosage: 200 mg/ Capsule; 1 capsule twice daily Route: Oral
Intervention Type
Other
Intervention Name(s)
Vitex negundo + Zingiber officinale
Intervention Description
200 mg/ Capsule
Intervention Type
Other
Intervention Name(s)
Placebo (MCC)
Intervention Description
200 mg/ Capsule
Primary Outcome Measure Information:
Title
Roland Morris Questionnaire
Description
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.
Time Frame
Days 0, Day 7 and Day 30.
Secondary Outcome Measure Information:
Title
Fingertip-to-Floor Test
Description
Using this test, the forward bending flexibility and mobility of individuals with chronic low back pain will be assessed, as well as the impact of IP consumption on the same in comparison to placebo. Participants will be asked to bend forward and attempt to touch the floor with their fingertips. The investigator will then measure the distance between the floor and the participant's right long finger using a standard measuring tape. The difference in height between the floor and the participant's right long finger will be compared from baseline to Day 30, and in comparison to the placebo
Time Frame
Days 0,and 30.
Title
Pain Visual Analogue Scale
Description
Participants will be asked to recall the pain they experienced in the specified lower back region, after which they will be asked to mark a point on the 100-point visual analogue scale that corresponds to the level of pain experienced. Participants will have to self-administer the scale.
minimum score 0 is referred to no pain at all and Maximum Score 100 is referred to as the worst possible pain
Time Frame
Days 0, 7 and 30.
Title
Work Productivity and Activity Impairment Questionnaire
Description
Chronic low back pain has been associated with lower work productivity in several studies. Using the Work Productivity and Activity Impairment Questionnaire, the impact of chronic low back pain on work and the performance of regular activities will be studied. The questionnaire consists of six questions, all the replies being categorized into 4 groups: 1) Percentage worktime missed, 2) Percentage impairment while working, 3) Percentage overall work impairment and 4) Percentage activity impairment.
Time Frame
Days 0,and 30.
Title
Insomnia severity index
Description
Participants will be asked to recall their sleep patterns for the past month and then fill the aforementioned questionnaire on baseline and Day 30. In this study, the Change of insomnia severity due to chronic low back pain will be studied throughout the study duration from baseline and in comparison to placebo.
The score ranges for the same are as follows:
0-7: No clinically significant insomnia 8-14: Subthreshold insomnia 15-21: Clinical insomnia (moderate severity) 22-28: Clinical insomnia (severe)
Time Frame
Days 0,and 30.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Participants with acute low back pain associated with chills or fever
Participants who are pregnant/breast feeding or are planning to get pregnant during the course of the study.
Individuals who have receives treatment with another investigational agent within the last 30 days.
Participants with known or suspected history of alcohol ordrug abuse based on medical history, physical examination, or the Investigators clinical judgment.
Facility Information:
Facility Name
Dr. Adkar clinic
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400067
Country
India
Facility Name
Shree Polyclinic
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400067
Country
India
12. IPD Sharing Statement
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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
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