| CTRI Number |
CTRI/2024/07/071243 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial of De-stress and Focus Capsule in the management of stress. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel arm clinical trial of De-Stress and Focus Capsule in the Management of Stress, Mental Alertness, Fatigue, and Anxiety |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/017 Ver. 1.00 Dated 25-June-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramshyam Agarwal |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Room no 401 OPD Fourth floor 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
8087282022 |
| Fax |
- |
| Email |
ramshyam.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kriti Soni |
| Designation |
Global Head R and D |
| Affiliation |
Herbolab India Pvt. Ltd. |
| Address |
3rd Floor A Wing Marwah Centre Krishanlal Marwah Marg Marol
Andheri East
Mumbai
MAHARASHTRA
400072
India |
| Phone |
9871018383 |
| Fax |
- |
| Email |
kriti.soni@rpsg.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kriti Soni |
| Designation |
Global Head R and D |
| Affiliation |
Herbolab India Pvt. Ltd. |
| Address |
3rd Floor A Wing Marwah Centre Krishanlal Marwah Marg Marol
Andheri East
Mumbai
MAHARASHTRA
400072
India |
| Phone |
9871018383 |
| Fax |
- |
| Email |
kriti.soni@rpsg.in |
|
|
Source of Monetary or Material Support
|
| Herbolab India Pvt Ltd Floor - 6th, F-15 ,Plot 78, Commerce Centre, Pandit Madan Mohan
Malviya Marg, Tardeo, Mumbai, 400034 |
|
|
Primary Sponsor
|
| Name |
Herbolab India Pvt Ltd |
| Address |
3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol,
Andheri East MUMBAI, MAHARASHTRA, 400072.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramshyam Agarwal |
Lokmanya Medical Research Centre and Hospital |
Room no 401 OPD Fourth-floor
314 B Telco Road
Chinchwad
Pune
MAHARASHTRA |
8087282022
-
ramshyam.research@gmail.com |
| Dr Dnyanraj Choudhary |
Sangvi Multispeciality Hospital Pvt. Ltd. |
Sr.No. 71/1/2/189 City Survey No. 2387 Krushna Chowk, Krushna Nagar, New Sangvi
Pune
MAHARASHTRA |
9823217423
-
drdnyanraj.sangvihospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
| Institutional Ethisc Committee Sangvi Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental focus, Alertness issues |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
De-Stress and Focus capsule - I001 |
Two capsules in sequence daily after meal for 60 days. |
| Intervention |
De-Stress and Focus capsule- U001 |
Two capsules in sequence daily after meal for 60 days. |
| Comparator Agent |
Placebo capsules 001 |
Two capsules in sequence daily after meal for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged 18-50 years both inclusive 2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3. Scoring 18-26 on the Montreal Cognitive Assessment MoCA 4. No or minimal impairment in activities of daily living: scoring less than 9 on the Functional Activities Questionnaire FAQ 5. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form 6. No severe anxiety and depression on GAD and PHQ-9 scales 7. Able to complete the cognitive assessment tests |
|
| ExclusionCriteria |
| Details |
1.Inability to perform any of the assessments required for endpoint analysis
2.Shows signs of Dementia, such as caused by Alzheimer’s Disease, acquired immunodeficiency syndrome AIDS, Creutzfeldt-Jakob disease, Lewy Bodies dementia LBD, Cerebrovascular dementia CVD, Progressive Supranuclear Palsy PSP, multiple cerebral infarctions, or normal pressure hydrocephalus NPH, cardiac disease or endocrine disease
3.Have any other neurodegenerative diseases
4.History of a seizure disorder
5.Known hypersensitivity to investigational products
6.Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
7.Sitting or resting systolic blood pressure more than 180 mm Hg or diastolic blood pressure more than 110 mm Hg at Screening.
8.Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
9.Participants currently using medications and or supplements that could have cognitive or mood effects including but not limited to nutraceutical, allopathic, ayurvedic herbal extract or supplement
10.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
11.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude the successful completion of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes are as follows-
1.Changes in perceived stress scale (PSS) score, Montreal Cognitive Assessment (MoCA) scale score, Rey Complex Figure Test (RCFT), Trail Making Test (TMT) score, digit span memory test, fatigue severity scale (FSS) score, mental chatter 5-point scale, Epworth Sleepiness Scale for daytime sleepiness, energy levels by using energy audit diary.
2.Assessment of alertness, orientation, and executive control functioning and executive/arousal vigilance will be assessed using ANTI-Vea-UGR computerized test(5 participants from each group i.e, total 15 participants)
3. Assessment of changes in the adult ADHD Self-Report Scale (ASRS) score
4.COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, STAI (State-Trait Anxiety Inventory) score, Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression)
5.Serum cortisol levels |
1.Screening, baseline, day 15, day 30, day 60
2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60
3.Screening, baseline, day 15, day 30, day 60
4.Screening and day 60
5.screening, day 15 and day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes are as follows- 1.Assessment of adverse events, treatment compliance and tolerability of investigational products, changes in vital sign parameters 2.Assessment of changes in complete blood count, liver function test and kidney function test |
1.Baseline, day 15, day 30, day 60
2.Screening and day 60 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The current study focuses in clinical validation of efficacy of nutraceutical product in management of mental focus and cognition. The benefits of these nutraceuticals extend beyond mere cognitive enhancement. Improved mental focus can lead to increased productivity and efficiency in both personal and professional settings. Individuals who struggle with attention deficits or cognitive fog may find that these supplements help them maintain a sharper and more consistent level of mental clarity. This can translate to better performance at work, as well as improved ability to manage daily tasks and responsibilities. |