NCT05602389

Study to Assess the Effect of Multi-herb Formulae and an Ashwagandha Root Formula on the Modulation of the Stress and Related Symptoms

A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Effect of Multi-herb Formulae VL-G-A57 and an Ashwagandha Root Formula (VL-G-E12) on the Modulation of the Hypothalamic-pituitary-adrenal Axis (HPA Axis) and Related Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Two unique proprietary formulations of adaptogens VL-G-E12 formulation and an herbal blend containing VL-G-A57 is one of the most well-known adaptogens that has been used for years to enhance positive mood states, deepen sleep, and improve memory. The product has been proven to have a role in improving depression, enhancing work performance, eliminating fatigue and treating symptoms of asthenia subsequent to intense physical and psychological stress. The extract was tested on antidepressant, adaptogenic, anxiolytic, nociceptive and locomotor activities at doses of 10, 15 and 20 mg/kg, using predictive behavioral tests and animal models. The results show that this product extract significantly, but not dose-dependently, induced antidepressant-like, adaptogenic, anxiolytic-like and stimulating effects in mice. Studies reveal that this shrub has antimicrobial (including antibacterial, antiviral, antifungal, antiprotozoal, antimalarial, anthelmintic), anti-inflammatory, anti-diabetic, anti-hypercholesterolemia, anti-hypertensive, anti-carcinogenic, and immunomodulatory effect.The aim of the current study is to assess the adaptogenic effects of two potential investigational products VL-G-A57 and VL-G-E12 Their adaptogenic effect shall be investigated by assessing several clinical symptoms of HPA axis dysfunction such as stress, anxiety, sleep quality, fatigue, mood etc.

Conditions

• Stress

Interventions

Type	Name	Description
OTHER	VL-G-A57	Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
OTHER	VL-G-E12	Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
OTHER	Placebo	Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2022-11-02
• Last updated: 2023-09-06

Locations

5 sites across 1 country: India