Study to Assess the Effect of Multi-herb Formulae and an Ashwagandha Root Formula on the Modulation of the Stress and Related Symptoms
- Conditions
- Stress
- Interventions
- Other: VL-G-A57Other: VL-G-E12Other: Placebo
- Registration Number
- NCT05602389
- Lead Sponsor
- Vedic Lifesciences Pvt. Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VL-G-A57 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 VL-G-E12 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 Placebo 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
- Primary Outcome Measures
Name Time Method Perceived stress scale Day 60 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.
- Secondary Outcome Measures
Name Time Method Restorative sleep questionnaire Day 0, 30 and 60 To assess change in the total score of the restorative sleep questionnaire weekly RSQ-W is a validated scale for measuring refreshing quality of sleep. It has 9 items with answers scaled from 1 to 5. The questioned asked about one felt after waking up and starting the day during the past seven days. Refer to the questionnaire at Appendix 3
Question 9 is to be reversed scored. The total score is an average score based on all 9 items and rescaled to a 0 to 100 scale, using the following transformation:
RSQ-W Total Score = (RSQ-W average score across completed items - 1) X 25. The participants will be asked to administer this scale during screening visit. Those fulfilling the criteria (RSQ-W score ≤ 50), will further fill this scale at day 0, day 30 and day 60 for assessing the efficacy.Adrenocorticotropic Hormone (ACTH) in plasma Day 0, 30 and 60 To assess changes in Adrenocorticotropic Hormone (ACTH) in plasma
Morning Salivary Cortisol Day 0, 30 and 60 To assess changes in morning Salivary Cortisol
Impact of the IP on the Mental alertness Day 0, 30 and 60 To assess the impact of the IP on the Mental alertness of the participants using a three-pointer scale after rising The scoring will be done as following: 1 = alert, 2 = slightly drowsy and 3 = extremely drowsy
Fatigue Severity Scale Day 0, 30 and 60 To assess the impact of IP on Fatigue using the Fatigue Severity Scale. The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement, and the final score represents the mean value of the 9 items. A visual analogue scale is also included with the scale in which the respondents will be asked to denote the severity of their fatigue at the present moment by placing a mark on a line extending from "no fatigue" to "fatigue as bad as could be." Higher scores on the scale are indicative of more severe fatigue.
Pittsburgh Sleep Quality Index. Day 0, 30 and 60 To assess sleep quality using Pittsburgh Sleep Quality Index.
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21).
Higher scores indicate worse sleep quality.Depression, Anxiety, Stress Scale-21 Day 0, 30 and 60 To assess the impact of the IP on total scores of Depression, Anxiety, Stress Scale-21 Higher score indicates worst Depression, Anxiety, Stress.
Trial Locations
- Locations (5)
The Kewalramani Clini
🇮🇳Mumbai, Maharashtra, India
Dr Chandrakant Mishra clinic
🇮🇳Pālghar, Maharashtra, India
Stress test clinic
🇮🇳Mumbai, Maharashtra, India
Vedic Lifesciences PVT LTD
🇮🇳Mumbai, Maharashtra, India
Shree Polyclinic
🇮🇳Mumbai, Maharashtra, India