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

NCT05602389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2023-09-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr Shalini Srivastava, MD medicine · Vedic Lifesciences Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2023-07-12
Completion
2023-07-12

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602389 on ClinicalTrials.gov