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

NCT05602389 | Completed

• 1 other identifier: GH/220602/A57E12/HPA
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (3)

• Perceived stress scale

  To assess the impact of the Investigational Product (IP) on stress levels by using the Perceived stress scale (PSS)from baseline. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.

  Day 0

• Perceived stress scale

  To assess the impact of the Investigational Product (IP) on stress levels by using the Perceived stress scale (PSS)from baseline. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.

  Day 30

• Perceived stress scale

  To assess the impact of the Investigational Product (IP) on stress levels by using the Perceived stress scale (PSS)from baseline. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.

  Day 60

Secondary Outcomes (7)

• Pittsburgh Sleep Quality Index.

  Day 0, 30 and 60

• Restorative sleep questionnaire

  Day 0, 30 and 60

• Adrenocorticotropic Hormone (ACTH) in plasma

  Day 0, 30 and 60

• Morning Salivary Cortisol

  Day 0, 30 and 60

• Impact of the IP on the Mental alertness

  Day 0, 30 and 60

Study Arms (3)

VL-G-A57

EXPERIMENTAL

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-A57

VL-G-E12

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

VL-G-A57 OTHER

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

VL-G-A57

VL-G-E12 OTHER

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

VL-G-E12

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• BMI: 18 to 29.9 kg/m2
• RSQ-W (Restorative Sleep Questionnaire-weekly version) score less than or equal to 50
• PSS scores ranging from 27-40
• All participants will be encouraged to not make any major lifestyle changes during the study period.
• Participants willing to provide written informed consent.

You may not qualify if:

• 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.
• 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.
• Subjects with a blood pressure range of systolic ≥ 140 mm Hg and diastolic ≥ 90 mm Hg.
• Subjects on any sleep medication since last 3 months
• Subjects with a history of severe intrinsic sleep related disorders.
• Subjects who have taken Ashwagandha or any sleep or other supplements within the last three months,
• People with a known hypersensitivity to Ashwagandha
• Subjects who work on a night shift
• Nursing or pregnant women

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (5)

Vedic Lifesciences PVT LTD

Mumbai, Maharashtra, 400053, India

Location

Stress test clinic

Mumbai, Maharashtra, 400059, India

Location

Shree Polyclinic

Mumbai, Maharashtra, 400067, India

Location

The Kewalramani Clini

Mumbai, Maharashtra, 400068, India

Location

Dr Chandrakant Mishra clinic

Pālghar, Maharashtra, 401209, India

Location

Study Officials

• Dr Shalini Srivastava, MD medicine

  Vedic Lifesciences Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A randomized, placebo-controlled, double-blind study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study Products: VL-G-A57 (Arm 1), VL-G-E12 (Arm 2) \& Placebo (Arm 3) Dose: 700 mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 2, 2022
• Study Start: December 8, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)