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

Vedic Lifesciences

Status: Completed

Conditions: Stress

Treatments: Other: VL-G-A57; Other: VL-G-E12; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05602389

GH/220602/A57E12/HPA

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male and female subjects ≥18 and ≤ 65 years' old with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
2. BMI: 18 to 29.9 kg/m2
3. RSQ-W (Restorative Sleep Questionnaire-weekly version) score less than or equal to 50
4. PSS scores ranging from 27-40
5. All participants will be encouraged to not make any major lifestyle changes during the study period.
6. They will be informed that any major changes may result in exclusion from the study.
7. Participants willing to provide written informed consent.

Exclusion Criteria

1. Subjects with a medical history of heart disease, respiratory disorders, metabolic or lifestyle disorders, seizure disorders, or other chronic health conditions requiring medication were excluded.
2. Individuals who currently, or in the past 6 months suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 5.0.01 ) or were taking apsychotropic medication or other herbal preparation were also excluded from participating in the study.
3. Subjects with a blood pressure range of systolic ≥ 140 mm Hg and diastolic ≥ 90 mm Hg.
4. Subjects on any sleep medication since last 3 months
5. Subjects with a history of severe intrinsic sleep related disorders.
6. Subjects who have taken Ashwagandha or any sleep or other supplements within the last three months,
7. People with a known hypersensitivity to Ashwagandha
8. Subjects who work on a night shift
9. Nursing or pregnant women

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 3 patient groups, including a placebo group

VL-G-A57

Experimental group

Description:

Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days

Treatment:

Other: VL-G-A57

VL-G-E12

Experimental group

Description:

Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days

Treatment:

Other: VL-G-E12

Placebo

Placebo Comparator group

Description:

Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days

Treatment:

Other: Placebo