| CTRI Number |
CTRI/2024/03/063786 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To understand the safety and effects of Ashwagandha in healthy adults with stress |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Parallel, placebo-controlled Clinical
lnterventional Study to Evaluate the Safety and Efficacy of zenroot Ashwagandha 1.5% on Stress,
Anxiety and Mood in Subjects with Stress.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manasvi M |
| Designation |
Principal Investigator |
| Affiliation |
Bengaluru Neuro Centre |
| Address |
Bengaluru Neuro Centre, 1st floor, Psychiatry Department, 10th cross Margosa Road, Malleshwaram, Bangalore, Karnataka - 560003, India
Bangalore
KARNATAKA
560003
India |
| Phone |
9742672407 |
| Fax |
|
| Email |
manasvi7393@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channabasavanna G Halasagi |
| Designation |
Senior Manager Medical Affairs |
| Affiliation |
Invitro Research Solutions Pvt. Ltd |
| Address |
Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Medical Monitoring Division, 3rd floor
No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,
Bangalore 560092, India
Bangalore
KARNATAKA
560092
India |
| Phone |
6366947473 |
| Fax |
|
| Email |
channa@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
T Vijaya Bhaskar |
| Designation |
Director Clinical Development |
| Affiliation |
Invitro Research Solutions Pvt. Ltd |
| Address |
Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Clinical Operations Division, 3rd floor
No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,
Bangalore 560092, India
Bangalore
KARNATAKA
560092
India |
| Phone |
6366575282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| OmniActive Health Technologies Limited
A 10, Road No.1, Wagle Industrial Estate, Thane West - 400604, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
OmniActive Health Technologies Limited |
| Address |
A10, Road No. 1, Wagle Industrial Estate,
Thane West 400604, Maharashtra, India |
| Type of Sponsor |
Other [Nutraceuticals industry - Indian ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manasvi M |
Bengaluru Neuro Centre |
Bengaluru Neuro Centre 10th Cross, Margosa Road, Malleswaram, Bengaluru, psychiatric Department, (Consultation room), 2nd floor, Karnataka 560003
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9742672407
manasvi7393@gmail.com |
| Dr Ruchi Gupta |
Santosh Hospital |
Santosh Hospital 6 1
Promenade Rd behind
Coles park Pulkeshi
Nagar Pulikeshi Nagar,
Bengaluru Karnataka
560005. Pschiatry Depa
rtment,(Consultaion
Room) Ground Floor,
room number11
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9880051351
drruchibrise@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Santosh Hospital IEC (For Bengaluru Neuro Centre) |
Approved |
| Santosh Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stressed Individuals
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Zenroot 125 mg Capsules |
Subjects will be instructed to consume one capsule every morning after breakfast, at the same time every day, for 84 days (12 weeks). |
| Comparator Agent |
Microcrystalline Cellulose
Placebo Capsules |
Subjects will be instructed to consume one capsule every morning after
breakfast, at the same time every day, for 84 days (12 weeks).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Stressed male or female adults aged between 18 to 55 years (both limits inclusive).
2. BMI of 18.5 kg/m2
to 29.9 kg/m2
(both limits inclusive).
3. Subjects with mild to moderate stress as determined by a score ≥7 or ≤26 on the
PSS.
4. Subjects who agree to maintain their usual dietary habits and level of exercise i.e.
maintain their usual lifestyle throughout the trial period.
5. Subjects willing to refrain from taking any medications or preparations for
addressing stress or anxiety or mood (herbal, dietary supplements, homeopathic
preparations, etc.) during the study.
6. Subjects willing to refrain from consuming alcohol 24 hours prior to the test days.
7. Subjects willing to refrain from consuming caffeine and caffeine-containing
products 12 hour prior to test days
8. Subjects willing to refrain from vigorous physical activity 12 hours prior to test
days.
9. Subjects who agree to stay weight stable during the study period.
10. Subjects who agree to have a minimum 7–8-hour sleep before the visit days and
during the study period.
11. Female subjects of child bearing potential practicing an acceptable method of birth
control such as Intrauterine Device in place for at least 3 months prior to the start
of the study and remaining in place during the study period, contraceptive
transdermal, injection or implants, non-hormonal or hormonal, abstinence:
Subjects who shall be practicing abstinence shall agree to have a documented
second acceptable method of birth control should the subject become sexually
active during the course of her study participation for the duration of the study as
judged by the investigator(s)/study physician and agree to follow the same should
be used during treatment.
OR
Postmenopausal for at least 1 year.
OR
Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy
has been performed on the subject).
12. Subjects willing to provide written consent.
13. Subjects shall be willing and able to understand and comply with the requirements
of the study, consume the study IP as instructed, return for the required treatment
period visits, comply with therapy prohibitions, and be able to complete the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
2. Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal
condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency,
hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator
3. Subjects with a psychiatric diagnosis including anxiety or depression
4. Subjects with sleep disturbances and/or are taking sleep aid medication
5. Subjects having hypersensitivity or history of allergy to the study product
6. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally
acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications
7. Subjects with a history of drug and /or alcohol abuse at the time of enrolment
8. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
9. Subjects with positive Urine Pregnancy Test prior randomization
10. Subjects who have been treated with any investigational drug or investigational device within a
period of 3 months prior to study entry
11. Subjects with severe stress based on PSS score greater than 26
12. Subjects with uncontrolled hypertension -systolic blood pressure greater 160 mm Hg or diastolic blood
pressure greater 100 mm Hg at screening
13. Excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater than or equal to 3 cups of caffeinated
coffee/day) throughout the study period
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline on stress as assessed by Perceived Stress Scale |
Baseline and End of Study (Day 84) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change from baseline on stress biomarkers - serum cortisol levels, and salivary
alpha-amylase
Mean change from baseline on stress as assessed by Mindfield eSense Skin Response
and Mindfield eSense PULSE - Heart Rate Variability
Mean change from baseline on anxiety as assessed by Beck Anxiety Inventory
Mean change from baseline on mood as assessed by Profile of Mood States
Mean change from baseline on overall sleep quality as assessed by Pittsburgh Sleep
Quality Index (PSQI)
Mean change from baseline on safety as evaluated by hematology and biochemistry
measures, adverse events, vital signs
hair cortisol levels |
Baseline and End of Study (Day 84) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
26/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
stress is a common problem faced by everyone in day-to-day life from different sources like job,
family problems, pollution, noise etc. Stress is a condition arising from external physical or mental
overload. It can make a person feel embattled, nervous, anxious, or otherwise less capable of a full
and normal response to environmental demands. The study is A Prospective, Randomized, Double-Blind, Parallel, Placebo-controlled
Clinical Interventional Study to Evaluate the Safety and Efficacy of Zenroot
Ashwagandha 1.5% on Stress, Anxiety and Mood in Subjects with Stress.This herb has been studied as adaptogenic, antioxidant, anticancer, anxiolytic, antidepressant,
cardioprotective, thyroid modulating, immunomodulating, antibacterial, antifungal, anti-inflammatory,
neuroprotective, cognitive enhancing and hematopoietic agent. Ashwagandha contains a range of
bioactiveslike withanolides, sitoindosides and other alkaloids that are pharmacologically and medicinally
important. These protect the cells from oxidative damage and diseases. Considering all the benefits of Ashwagandha cited above, the present study will be conducted to evaluate
the efficacy of the Zenroot Ashwagandha 1.5% Capsules its adaptogenic properties to reduce stress and
its associated features. Additionally, Zenroot Ashwagandha 1.5% capsules will also be evaluated for its
positive impact on anxiety, mood, impaired sleep quality due to stress, cortisol and alpha-amylase
lowering property. |