| CTRI Number |
CTRI/2014/12/005247 [Registered on: 04/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
29/06/2015 |
| 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 Study to Evaluate the Efficacy of Herbal Extract on Immune Health in Healthy Adult Volunteers |
|
Scientific Title of Study
|
A Randomized, Double Blinded, Placebo Controlled,
Clinical Study to Evaluate the Efficacy of Herbal Extract on Immune Health in Healthy Adult Volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Babu |
| Designation |
Principal Investigator |
| Affiliation |
Director of Family Dental Care |
| Address |
Family Dental Care, First floor, KVN complex, Near Old Bus Stand, Devanahalli Town,
Bangalore Rural
KARNATAKA
562110
India |
| Phone |
09980636886 |
| Fax |
|
| Email |
drrajeshbabu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shylashree |
| Designation |
Medical Monitor |
| Affiliation |
Medical Monitor to provide clarifications for all scientific query |
| Address |
Semler Research Center Pvt Ltd
Bangalore
KARNATAKA
560 078
India
Bangalore
KARNATAKA
560 078
India |
| Phone |
080-42627240 |
| Fax |
|
| Email |
drshylb@semlerresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
T Vijay Bhaskar |
| Designation |
Project Manager |
| Affiliation |
Project Manager |
| Address |
Semler Research Center Pvt Ltd
Bangalore
KARNATAKA
560 078
India
Bangalore
KARNATAKA
560 078
India |
| Phone |
080-42627276 |
| Fax |
|
| Email |
vijay@semlerresearch.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Limited |
| Address |
Life Sciences and Technology Centre, ITC Limited, Peenya Industrial Area, Phase I,
Bangalore 560 058
|
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Babu |
Family Dental Care |
First floor, KVN complex, Near Old Bus Stand, Devanahalli Town, Bangalore Rural 562110
Bangalore Rural
KARNATAKA |
09980636886
drrajeshbabu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Being Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbal Extract |
Capsules given twice daily for 90 days |
| Comparator Agent |
NA |
There is no comparator agent in the study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female healthy volunteers between 18 to 55 years of age at the time of screening visit
2. Subject willing to voluntarily sign the informed consent form
3.If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable since last 3 months prior to baseline and throughout the study
|
|
| ExclusionCriteria |
| Details |
1. Subjects with deteriorating health status at the time of enrollment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhea, gastro-intestinal diseases, irritable bowel syndrome)
2.Autoimmune diseases, recent blood donation transfusion, immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection)
3.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
4.Subjects unwilling or unable to comply with the study procedures
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of this study is to evaluate the efficacy of Herbal Extract for modulating the immune health in healthy adult volunteers
|
NA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective is to evaluate the safety of Herbal Extract in healthy adult volunteers |
NA |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2014 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized, double-blind, parallel-group, placebo-controlled study on healthy adult volunteers. The primary objective of this study is to evaluate the efficacy of herbal extract for modulating the immune health in healthy adult volunteers and secondary objective is to evaluate the safety of herbal extract in healthy adult volunteers. A total of 70 subjects will be enrolled in 3 groups. Repeated measure ANCOVA will be performed for the primary variables using baseline as covarites if data are measurable else t-test will be performed between the treatments. |