Low Back PainNCT04980469
A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
A study testing Vitex negundo + Zingiber officinale in people with Low Back Pain, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Vitex negundo + Zingiber officinale
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesIndia
- Study dates
- 25 Sep 2021to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Dr. Adkar clinic
Mumbai, Maharashtra, 400067
Shree Polyclinic
Mumbai, Maharashtra, 400067
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Vitex negundo + Zingiber officinale, Placebo (MCC)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitex negundo + Zingiber officinaleOther
200 mg/ Capsule
Placebo (MCC)Other
200 mg/ Capsule
| Study group | Role | What they receive |
|---|---|---|
| Vitex negundo + Zingiber officinale | Experimental | Dosage: 200 mg/ Capsule;1 capsule twice daily Route: Oral Receives: Other: Vitex negundo + Zingiber officinale |
| Placebo (MCC) | Placebo comparator | Dosage: 200 mg/ Capsule; 1 capsule twice daily Route: Oral Receives: Other: Placebo (MCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 0, Day 7 and Day 30.
Secondary outcomes (4)
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
Measured: Days 0,and 30.
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
Measured: Days 0, 7 and 30.
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.
Measured: Days 0,and 30.
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)
Measured: Days 0,and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start25 Sep 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo controlled, Parallel group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980469
- Sponsor's protocol ID
- EB/210402/VT/LBP
- Status last verified
- Apr 2022
- First submitted
- 14 Jul 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04980469
- Acronym / sponsor ID
- EB/210402/VT/LBP
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo controlled, Parallel group
| Arm | Type | Receives |
|---|---|---|
| Vitex negundo + Zingiber officinale | Experimental | Other: Vitex negundo + Zingiber officinaleDosage: 200 mg/ Capsule;1 capsule twice daily Route: Oral |
| Placebo (MCC) | Placebo comparator | Other: Placebo (MCC)Dosage: 200 mg/ Capsule; 1 capsule twice daily Route: Oral |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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 .
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitex negundo + Zingiber officinale200 mg/ Capsule | Other | Vitex negundo + Zingiber officinale |
| Placebo (MCC)200 mg/ Capsule | Other | Placebo (MCC) |
Primary outcome
Roland Morris Questionnaire
Time frame: Days 0, Day 7 and Day 30.
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.
4 secondary outcomes
Fingertip-to-Floor Test
Time frame: Days 0,and 30.
Pain Visual Analogue Scale
Time frame: Days 0, 7 and 30.
Work Productivity and Activity Impairment Questionnaire
Time frame: Days 0,and 30.
Insomnia severity index
Time frame: Days 0,and 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitex negundo + Zingiber officinale in people with Low Back Pain, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Questionnaire (time frame: Days 0, Day 7 and Day 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.