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

NCT ID: NCT05602389

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2023-07-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

VL-G-A57

Intervention Type: 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

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

Group Type: EXPERIMENTAL

VL-G-E12

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Shalini Srivastava, MD medicine

Role: PRINCIPAL_INVESTIGATOR

Vedic Lifesciences Pvt. Ltd.

Locations

Vedic Lifesciences PVT LTD

Mumbai, Maharashtra, India

Stress test clinic

Mumbai, Maharashtra, India

Shree Polyclinic

Mumbai, Maharashtra, India

The Kewalramani Clini

Mumbai, Maharashtra, India

Dr Chandrakant Mishra clinic

Pālghar, Maharashtra, India

Countries

India

Other Identifiers

GH/220602/A57E12/HPA

Identifier Type: -

Identifier Source: org_study_id