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CTRI Number  CTRI/2019/02/017545 [Registered on: 07/02/2019] Trial Registered Prospectively
Last Modified On: 17/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effects of herbal supplement on reduction in stress and enhancement of immunity in healthy population.  
Scientific Title of Study   An Interventional, Randomized, Parallel Group, Placebo Controlled, Three Arm Clinical Study of Beverage Formulations (Formulation 3A and Formulation 3B) to assess reduction in stress and improvement in immunity in Healthy Population 
Trial Acronym  Anti-stress Beverage Study 
Secondary IDs if Any  
Secondary ID  Identifier 
DCCAS-18-001, Version 1.0, 10-Oct-18  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mili Bhattacharya 
Designation  Senior Manager- Scientific Nutrition and Regulatory Affairs 
Affiliation  Coca- Cola India 
Address  16th-17th Floor, One Horizon Centre, Golf Course Road, Sector 43

Gurgaon
HARYANA
122002
India 
Phone  9899912250  
Fax    
Email  mbhattacharya@coca-cola.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venkateshwarlu 
Designation  Consultant, Herbal and Ayurvedic Clinical Trials 
Affiliation  D2L Clinical Solutions Pvt Ltd. 
Address  Nandi Infotech, 1st Floor, KIADB Plot no.8,1st Cross, Sadaramangala Industrial Area, Mahadevpura Post

Bangalore
KARNATAKA
560048
India 
Phone  9945232107  
Fax    
Email  drvenkatesh64@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shekhar Gupta 
Designation  Chief Executive Officer 
Affiliation  D2L Clinical Solutions Pvt. Ltd 
Address  Nandi Infotech, 1st Floor, KIADB Plot no.8,1st Cross, Sadaramangala Industrial Area, Mahadevpura Post

Bangalore
KARNATAKA
560 048
India 
Phone  9741111101  
Fax  080-30850667  
Email  shekhar@d2lclinical.com  
 
Source of Monetary or Material Support  
Coca Cola India Pvt Ltd,One Horizon Centre (16th & 17th Floor), DLF Golf Course Road, DLF Phase 5, Sector 43, Gurgaon, Haryana- 122002, India 
 
Primary Sponsor  
Name  Coca Cola India Pvt Ltd 
Address  One Horizon Centre (16th & 17th Floor), DLF Golf Course Road, DLF Phase 5, Sector 43, Gurgaon, Haryana- 122002, India  
Type of Sponsor  Other [Beverage Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pawan Kumar Godatwar  National Institute of Ayurveda  Room No. 117, Department of Roga Nidana, National Institute of Ayurveda Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN 		 8005841032
91-141-2635709
pgodatwar@gmail.com 
Dr Denis Xavier  St. Johns Research Institute  Office of Vice Dean, Division of Clinical Research & Training, 100 Feet Rd, John Nagar, Koramangala
Bangalore
KARNATAKA 		 08049466140
91-80-25501088
drdenisxavier@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
St. Johns Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Formulation 3A  Contains base dosages of Withania somnifera (Ashwagandha) & Ocimum sanctum L (Tulasi) and excipients; 300mL beverage; Once Daily to be taken orally for one month. 
Intervention  Formulation 3B  Contains enhanced dosages of Withania somnifera (Ashwagandha) & Ocimum sanctum L (Tulasi); 300mL beverage; Once Daily to be taken orally for one month.  
Comparator Agent  Placebo  Identical beverage; 300mL; Once Daily to be taken orally for one month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Adult healthy subjects willing to provide a written Informed Consent
1.Age group: 18 - 45 Years
2.BMI: 18 - 25 kg/m2
3.No prior history of any allergy
4.Subjects with borderline immunity - IgG levels (600 - 799 mg/dl)
 
 
ExclusionCriteria 
Details  1.Severe immunosuppressed Subjects with IgG levels lower than 300 mg/dl
2.Chronic Smokers (more than 3 cigarettes / day)
3.Chronic alcoholics (more than 2 standard pegs / day)
4.Subjects with known secondary causes of hypogammaglobulinemia such as, nephrotic syndrome, renal disease, malignancy, etc.
5.Subjects taking immunosuppressants medications
6.Pregnant women or women planning for pregnancy during the study period
7.Subjects with known hypertension and other diseases of the cardiovascular system
8.Subjects with known liver diseases, kidney diseases, psychiatric diseases, epilepsy and/or with any other relevant diseases
9.Subjects with the intention of non-compliance to the study-protocol
10.Subjects participating in any another clinical trial simultaneously
11.Retraction of the written informed consent
12.Subjects currently taking medications other than oral contraceptive pill
13.Any other medical condition that in the Investigators opinion would preclude patient participation
14.Any antibiotic use in the past one week prior to entering the study
15.History of vaccination such as seasonal influenza vaccine in the past 2 months
16.Subjects taking health supplements
17.Subjects with deteriorating health status at the time of enrollment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhoea, irritable bowel syndrome etc.)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess the Efficacy of Beverage 3(formulation 3A and formulation 3B) for its anti-stress properties through Hamilton Anxiety Rating (HAM-A) Scale
2.To assess the Efficacy of Beverage 3(formulation 3A and formulation 3B) for its Immunity properties through Serum IgG Test 		 1.Baseline,7th,15th,21st,& 30th Day
2.Baseline, 30th, & 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the efficacy of beverage 3(formulation 3A and formulation 3B) for its anti-stress through Cohen’s perceived stress questionnaire (PSSQ-20)
2.To assess the efficacy of beverage 3(formulation 3A and formulation 3B) for its immunity properties through Immune-supportive properties in 20% Study Population as assessed through NK cells estimation test
3.To assess the Safety of Beverage 3(formulation 3A and formulation 3B) at baseline and end of the study  		 1.Baseline, 7th Day, 15th Day, 21st Day &30th Day
2.Baseline and 30th Day
3.Baseline and 30th Day 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The study outcome will be published by the sponsor at the public domain after completion of the study. Currently, there are no publication as yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The purpose of the study is to investigate reduction in stress levels and the improvement in and general immunity in 120 healthy subjects. In the proposed randomized, double-blind, placebo-controlled study, the lower  and higher dose of beverage containing herbal blend will be compared against placebo to evaluate safety, efficacy, and incremental dose effect. The treatment duration of the study will be 4 weeks. The various primary efficacy parameters considered are changes in the serum IgG levels, and improvement using Hamilton Anxiety Scale (HAM-A) Scale. Other secondary parameters include Cohen’s Perceived Stress Scale Questionnaire (PSSQ), estimation of natural killer cells (NK) Cells, and safety assessments for the subjects. 
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