NCT04980469

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Vitex negundo + Zingiber officinale	200 mg/ Capsule
OTHER	Placebo (MCC)	200 mg/ Capsule

Timeline

• Start date: 2021-09-25
• Primary completion: 2022-02-07
• Completion: 2022-02-07
• First posted: 2021-07-28
• Last updated: 2022-04-19

Locations

2 sites across 1 country: India