Clinical trial NCT05602389: Study to Assess the Effect of Multi-herb Formulae and an Ashwagandha Root Formula on the Modulation of the Stress and Related Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Perceived stress scale
timeFrame: Day 0
measure: Perceived stress scale
timeFrame: Day 30
measure: Perceived stress scale
timeFrame: Day 60
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index.
timeFrame: Day 0, 30 and 60
measure: Restorative sleep questionnaire
timeFrame: Day 0, 30 and 60
measure: Adrenocorticotropic Hormone (ACTH) in plasma
timeFrame: Day 0, 30 and 60
measure: Morning Salivary Cortisol
timeFrame: Day 0, 30 and 60
measure: Impact of the IP on the Mental alertness
timeFrame: Day 0, 30 and 60
measure: Fatigue Severity Scale
timeFrame: Day 0, 30 and 60
measure: Depression, Anxiety, Stress Scale-21
timeFrame: Day 0, 30 and 60
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Vedic Lifesciences PVT LTD
state: Maharashtra
city: Mumbai
country: India
facility: Stress test clinic
state: Maharashtra
city: Mumbai
country: India
facility: Shree Polyclinic
state: Maharashtra
city: Mumbai
country: India
facility: The Kewalramani Clini
state: Maharashtra
city: Pālghar
country: India
facility: Dr Chandrakant Mishra clinic
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr Shalini Srivastava, MD medicine
role: PRINCIPAL_INVESTIGATOR
References: