| CTRI Number |
CTRI/2019/02/017529 [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 improvement in general health condition in healthy population. |
|
Scientific Title of Study
|
An Interventional, Randomized, Parallel Group, Placebo Controlled, Three Arm Clinical Study of Beverage Formulations (Formulation 2-A and Formulation 2-B) to assess improvement in immunity and management of general health in Healthy Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DCCGH-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 |
| 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
|
|
|
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 Resarch & Training,
100 Feet Road, John Nagar, Koramangala
Bangalore
KARNATAKA |
08049466140
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Formulation 2A |
Contains base dosages of Withania somnifera (Ashwagandha) &
Phyllanthus emblica Linn. (Amla)
300mL once daily to be taken orally for one month. |
| Intervention |
Formulation 2B |
Contains enhanced dosages of Withania somnifera (Ashwagandha) &
Phyllanthus emblica Linn. (Amla);300mL once daily;orally for one month.
|
| Comparator Agent |
Placebo |
Identical beverage; 300mL once daily;orally for one month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults Healthy Subjects willing to provide a written Informed Consent
2.Age group: 18 - 45 Years
3.BMI: 18 - 25 kg/m2
4.No prior history of any allergy
5.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 2 (formulation 2A and formulation 2B) for the Immune-supportive properties through serum IgG test.
2.To assess the efficacy of beverage 2 (formulation 2A and formulation 2B) for General Health Properties Improvement using Quality of Life (QoL) scale for normal health. |
1.Baseline, 30th Day & 60th Day
2.Baseline, 7th Day, 15th Day, 21st Day & 30th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.NK Cells Estimation Test (for 20% of subjects)
2.Profile of mood states (POMS) Scale
3.Cohen’s Perceived Stress Scale Questionnaire (PSSQ)
4. Safety assessments |
1.Baseline and 30th Day
2.Baseline & 30th
3.Baseline, 7th Day, 15th Day, 21st Day & 30th Day
4.Baseline and 30th Day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2019 |
| Date of Study Completion (India) |
24/08/2019 |
| 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, 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 the improvement in physical energy and immunity in approximately 120 healthy subjects. In the proposed randomized, double-blind, placebo-controlled study, the lower (base) and higher dose of beverage containing herbal blend will be compared against placebo for evaluating 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 overall improvement using Quality of Life (QoL) Scale. Other secondary parameters include estimation of natural killer cells (NK) Cells, Profile of Mood scale, Perceived Stress Scale questionnaire, Cohen’s Perceived Stress Scale Questionnaire (PSSQ). |