FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064404 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 17/08/2024
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 evaluate effectiveness of a nutraceutical capsule on stress, sleep and mood in healthy subjects. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled study to evaluate effectiveness of a natural phytochemical formulation ARC23004, on stress, sleep and mood in Healthy subjects. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS24001, Version 00, Date:05 FEB 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Service 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft. Road, Satellite. Ahmedabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Service 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft. Road, Satellite. Ahmedabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Service 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft. Road, Satellite. Ahmedabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Source of Monetary or Material Support  
Aurea Biolabs Private Limited, XI/304A, Kadayiruppu, Kolenchery, Cochin, Kerala-682311 
 
Primary Sponsor  
Name  Aurea Biolabs Private Limited 
Address  XI/304A, Kadayiruppu, Kolenchery, Cochin, Kerala-682311 
Type of Sponsor  Other [Nutraceutical] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Archit Parikh  Ohm Hospital  OPD room-I, Ground Floor, 41/A, Karmachari Nagar-1, Opp Alkapuri Society, Ghatlodia
Ahmadabad
GUJARAT 		 9904771377

parikharchit@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ohm Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stress, Sleep and Mood 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ARC23004 - 120mg  Take 1 capsule of ARC23004 - 120mg before bed orally for 60 days. 
Intervention  ARC23004 - 60mg   Take 1 capsule of ARC23004 - 60mg before bed orally for 60 days. 
Comparator Agent  Placebo  Take 1 capsule of Placebo before bed orally for 60 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Subject with either gender, age between 18-65 (inclusive of both) years.
2) Subject having normal 12 lead ECG.
3) The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
4) Subject having a score of at least 14 on the Perceived Stress Scale (PSS), free of psychiatric conditions other than stress.
5) Subjects who usually take more than 30 min to fall asleep and habitually take subjective total sleep time of less than or equal to 6.5 h per night (for at least 3 nights per week), having daytime complaints associated with disturbed sleep, having habitual bedtime between 8.30 p.m. to midnight, and contained Body Mass Index between 18.5 and 29.9 kg/sq.
6) Subjects who have given voluntary, written, informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1) Subjects suffering from any chronic physical, hormonal or psychiatric illness.
2) Subjects with uncontrolled type 2 diabetics, blood pressure and symptomatic hypotension and heart disease.
3) History of heart attack, stroke and coronary/cerebrovascular events.
4) Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
5) History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
6) Subjects with previous history of surgery.
7) Pregnant and lactating women.
8) Participation in any other clinical study using investigational medicinal product, herbal/ nutritional formulation or device within 3 months prior to baseline visit.
9) Subjects taking any of the following classes of medications: benzodiazepines, central nervous system depressants, diabetes medication, thyroid medication, immune suppressors, cardiovascular medication, any supplementations that impact on mood, stress, and sleep.
10) Subjects currently taking any herbal preparations, nutritional
formulations, foods or formulations (including teas) containing valerian, chamomile, peppermint, mint, saffron, lavender, passionflower, lemon balm, tulsi, GABA, melatonin, theanine, magnesium, Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs.
11) Subjects practicing lifestyle approaches such as yoga, breathing techniques, meditation, relaxation exercises, aromatherapy, relaxation tapes, etc to manage stress.
12) Subjects who regularly take stimulants including but not limited to coffee, tea, colas/ soda, caffeine, teacrine, paraxanthine, guarana, herbal stimulants, etc. 2-3 hours before bed time.
13) Subjects who live in an environment that results in disturbed sleep patterns, e.g., household with small children/ babies that need attention in the night, noisy neighbourhoods, etc.
14) Subjects working in shift work.
15) Unwilling to come for regular follow-up for the entire duration of the study.
16) Non – co-operative attitude of the subject.
17) Subjects with substance dependence including dependence on alcohol.
18) Subjects with allergies to any of the study product components.
19) Any condition that, in the opinion of the investigator, does not justify the subject’s inclusion for the study.
20) Excluding smokers since smoking can impact both perceived stress levels and sleep quality and anyone that consumes more than 2 drinks per day.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Impact of ARC23004 on Hamilton Anxiety Rating Scale HAM-A
2) Impact of ARC23004 on Perceived Stress
3) Impact of ARC23004 on Sleep
4) Bond-Lader VAS (Mood Rating Scale) (BL-VAS) 		 60 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1) Hormonal changes in serum cortisol between 6-8 am and at 4 pm, Serotonin, dehydro epiandrosterone sulphate (DHEA-S) and testosterone.  60 days 
2) Change in stress and anti-inflammatory biomarkers (Cortisol between 6-8 am and at 4 pm, C-reactive protein (CRP), IL-6, TNF-a).  60 days 
3) Change in BP and pulse.  60 days 
4) Fasting blood glucose.  60 days 
5) Change in CBC and blood lipids  60 days 
6) To assess Global Quality of Life Scale.  60 days 
7) To demonstrate safety and tolerability of study product by clinical monitoring of adverse events.  60 Days 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
Final Enrollment numbers achieved (Total)= "98"
Final Enrollment numbers achieved (India)="98" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 09/04/2024 
Date of Study Completion (India) 14/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="7" 
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   This study will be conducted to evaluate effectiveness of a natural phytochemical formulation "ARC23004", on stress, sleep and mood in Healthy subjects. Sufficient number of subjects will be enrolled in the study to get 90 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subject’s visit 1 will be screening and randomization visit.  Follow up visit 2 will be on 7 ± 2 days, Follow up visit 3 will be on 30 ± 2 days and end of study visit will be on 60 ± 2 days. Subjects will be screened for the eligibility criteria during screening visit.

 The subjects will be randomized in the ratio of 1:1:1 where they will either receive test product 60 mg, test product 120 mg or placebo. Subjects will be instructed to take 1 capsule before bed orally. Primary endpoint will be Impact of ARC23004 on Hamilton Anxiety Rating Scale HAM-A,  on Perceived Stress and on sleep and also Bond-Lader VAS (Mood Rating Scale) (BL-VAS) from Baseline, Visit 3 and EOS. The secondary endpoint will be Hormonal changes in serum cortisol* between 6-8 am and at 4 pm, Serotonin, dehydro epiandrosterone sulphate (DHEA-S) and testosterone, Change in stress and anti-inflammatory biomarkers, Fasting blood glucose from  Baseline, Visit 3 and EOS. Change in BP and pulse, Change in CBC and blood lipids and assessment of Global Quality of Life Scale in Baseline and EOS will be performed. Also the frequency and intensity of AEs will be demonstrated.
 
Close