StressNCT05602389
Study to Assess the Effect of Multi-herb Formulae and an Ashwagandha Root Formula on the Modulation of the Stress and Related Symptoms
A study testing VL-G-A57 and VL-G-E12 in people with Stress, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- VL-G-A57 and VL-G-E12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 5 sitesIndia
- Study dates
- 8 Dec 2022to 12 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- They will be informed that any major changes may result in exclusion from the study.
- Participants willing to provide written informed consent.
Who cannot join
- 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,
Show all 9Show fewer
- People with a known hypersensitivity to Ashwagandha
- Subjects who work on a night shift
- Nursing or pregnant women
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Vedic Lifesciences PVT LTD
Mumbai, Maharashtra, 400053
Stress test clinic
Mumbai, Maharashtra, 400059
Shree Polyclinic
Mumbai, Maharashtra, 400067
The Kewalramani Clini
Mumbai, Maharashtra, 400068
Dr Chandrakant Mishra clinic
Pālghar, Maharashtra, 401209
About this study
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
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
- Being tested
- VL-G-A57, VL-G-E12, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VL-G-A57Other
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-E12Other
Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
PlaceboOther
Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 60
Secondary outcomes (7)
Pittsburgh Sleep Quality Index.
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.
Measured: Day 0, 30 and 60
Restorative sleep questionnaire
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.
Measured: Day 0, 30 and 60
Adrenocorticotropic Hormone (ACTH) in plasma
To assess changes in Adrenocorticotropic Hormone (ACTH) in plasma
Measured: Day 0, 30 and 60
Morning Salivary Cortisol
To assess changes in morning Salivary Cortisol
Measured: Day 0, 30 and 60
Impact of the IP on the Mental alertness
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
Measured: Day 0, 30 and 60
Fatigue Severity Scale
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.
Measured: Day 0, 30 and 60
Depression, Anxiety, Stress Scale-21
To assess the impact of the IP on total scores of Depression, Anxiety, Stress Scale-21 Higher score indicates worst Depression, Anxiety, Stress.
Measured: Day 0, 30 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start8 Dec 2022
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Shalini Srivastava, MD medicine, Principal investigator, Vedic Lifesciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602389
- Sponsor's protocol ID
- GH/220602/A57E12/HPA
- Status last verified
- Sep 2023
- First submitted
- 21 Oct 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKinney E, Stewart J, Kewalramani R, Singh S. Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study. Trials. 2026 Feb 9;27(1):205. doi: 10.1186/s13063-026-09495-9.
PubMed 41656269
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05602389
- Acronym / sponsor ID
- GH/220602/A57E12/HPA
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| VL-G-A57 | Experimental | Other: VL-G-A57Dose: 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 | Experimental | Other: VL-G-E12Dose: 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 comparator | Other: PlaceboDose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VL-G-A57Dose: 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-E12Dose: 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 |
| PlaceboDose: 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 |
Primary outcome
Perceived stress scale
Time frame: Day 0
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.
Perceived stress scale
Time frame: Day 30
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.
Perceived stress scale
Time frame: 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.
7 secondary outcomes
Pittsburgh Sleep Quality Index.
Time frame: Day 0, 30 and 60
Restorative sleep questionnaire
Time frame: Day 0, 30 and 60
Adrenocorticotropic Hormone (ACTH) in plasma
Time frame: Day 0, 30 and 60
Morning Salivary Cortisol
Time frame: Day 0, 30 and 60
Impact of the IP on the Mental alertness
Time frame: Day 0, 30 and 60
Fatigue Severity Scale
Time frame: Day 0, 30 and 60
Depression, Anxiety, Stress Scale-21
Time frame: Day 0, 30 and 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 41656269McKinney E, Stewart J, Kewalramani R, Singh S. Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study. Trials. 2026 Feb 9;27(1):205. doi: 10.1186/s13063-026-09495-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shalini Srivastava, MD medicine principal investigator
Vedic Lifesciences Pvt. Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VL-G-A57 and VL-G-E12 in people with Stress, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress scale (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.