A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Vitex negundo + Zingiber officinale; Placebo (MCC)
Intervention type(s): Other; Other
Intervention description(s): 200 mg/ Capsule; 200 mg/ Capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Placebo controlled, Parallel group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other