| CTRI Number |
CTRI/2022/06/043331 [Registered on: 17/06/2022] Trial Registered Prospectively |
| Last Modified On: |
02/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of KaraShield-a herbal formulation towards the enhancement of immunity in healthy population. |
|
Scientific Title of Study
|
A prospective, randomized, double-blind, placebo-controlled clinical study for the assessment of immunomodulatory properties of KaraShield on general healthy population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DGCKL/KS/01/22; Version 1.0, Date: 30 April 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sucharitha L |
| Designation |
Ayurvedic Physician |
| Affiliation |
Shetty’s Hospital |
| Address |
Dept. of Ayurveda, Room No. 1, First Floor, Plot No.11 &12, 12th F Main, Kaveri Nagar, Bommanahalli, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
080-30850666 |
| Fax |
|
| Email |
sucharitha.pandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ravi |
| Designation |
Manager |
| Affiliation |
Green Chem |
| Address |
2030, Unit 1A, Kodihalli, Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
08025269569 |
| Fax |
|
| Email |
ravi3894@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Dheeraj Kumar Deep |
| Designation |
Head-Clinical Operations |
| Affiliation |
D2L Clinical Solutions Pvt. Ltd. |
| Address |
1st Floor, Nandi Infotech, KIADB Plot # 8,1st Cross, Sadaramangala Industrial Area, Mahadevapura Post Bangalore
Bangalore
KARNATAKA
560048
India |
| Phone |
08030850666 |
| Fax |
|
| Email |
dheeraj@d2lclinical.com |
|
|
Source of Monetary or Material Support
|
| Karallief Inc. |
| Shettys Hospital |
| Sri Venkateshwara Hospital |
|
|
Primary Sponsor
|
| Name |
Green Chem |
| Address |
2030, Unit 1A, 1st Cross Road, HAL 2nd Stage, Kodihalli, Bangalore-560008 |
| Type of Sponsor |
Other [Herbal & Nutraceutical Products Manufacturer] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Karallief Inc |
One Mifflin Place, Suite 400, Cambridge, MA 02138, USA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sucharita L |
Shettys Hospital |
Room no. 1, Dept. of Ayurveda, Plot No, 11 & 12, 12th F Main Road, Kaveri Nagar, Bommanahalli
Bangalore
KARNATAKA |
08025732886
sucharitha.pandit@gmail.com |
| Dr Latha K |
Sri Venkateshwara Hospital |
Room no.5, Dept. of Ayurveda, #27, 29th Main Road, Rashtra Kavi Kuvempu Nagara,
BTM 2nd Stage, BTM Layout, Bengaluru-560076
Bangalore
KARNATAKA |
080-30850666
latha.latha2008@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Shetty’s Hospital Ethics Committee |
Submittted/Under Review |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Upper Respiratory Tract Infections |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KaraShield |
500 mg, OD, Oral, 60 days |
| Comparator Agent |
Placebo |
500 mg, OD, Oral, 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Healthy male and female subjects between the age groups of 18–60 years, who have a history of recurrent (at least 2 episodes and above in the last 2 months) upper respiratory tract infection (URI) and related symptoms such as common cold, cough, sore (scratchy) throat, nasal discharge (runny nose), nasal obstruction (plugged or congested), sneezing, headache, low-grade fever (malaise), tiredness/bodyache, chillness, etc. due to common cold and/ or seasonal change-related immunity disorders (except the allergic conditions) and/ or who have lower value of normal range for IgG at the time of study participation (baseline) (Normal range of IgG in adult: 600–1600 mg/dL or, 6-16 g/L).
• Subjects willing to participate and comply with the protocol procedures by signing an Informed Consent Form to participate in the study.
|
|
| ExclusionCriteria |
| Details |
• Subjects with the current habit or history of cigarette smoking.
• Subjects with the current habit of alcohol consumption more than 2 standard drinks/ day.
• Subjects with very high level of IgE <700 KU/L (allergic patient)
• Subjects with the confirmed case of pneumonia or bronchitis.
• Subjects with allergic rhinitis, sinusitis/ Pharyngitis or any other oropharyngeal disorder.
• Subjects who underwent or need tonsillectomy or adenoidectomy.
• Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc.
• Subjects suffering from proteinuria (loss of protein in urine).
• Subjects on any seizure medication.
• Subjects on any other medication known to reduce IgG levels.
• Subjects with a known history of any malignant disease.
• Subjects with known history of autoimmune disease and other systemic diseases related to immune system.
• Subjects with chronic immune diseases like HIV.
• Subjects suffering with the infectious diseases HBsAg and HCV
• Subjects treated with the following medications:
a)Antibiotics less than one week before the study
b)Any vaccination less than 4 weeks before the study
c)Concomitant immunosuppressive or immune-stimulating therapy 3 months before the study start.
• Subjects with concomitant treatment with corticosteroids.
• Subjects who participated in another clinical trial less than 3 months prior to this study.
• Subjects who are suffering from any communicable disease.
• Female subjects, who are pregnant, breast feeding or expecting pregnancy during the study period.
• Subjects with the history of consumption of any recreational drugs (such as cocaine, methamphetamine, marijuana, etc).
• Subjects who are scheduled for any surgery within 3 months period of completing the study.
• Subjects who are pre-diabetic/ diabetic or hypertensive or hyperlipidemic
• Subjects with inability or unwillingness to abide by the requirements of the protocol.
• Subjects who are incompetent to sign an Informed Consent Form.
• Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol. |
|
|
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 |
| Incidence of clinically confirmed episodes of Upper Respiratory Tract Infection (URI) related symptoms measured through Wisconsin Upper Respiratory Symptom Survey (WURSS-24) Score |
Day 0, Day 7, Day 15, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunity status Questionnaire (ISQ) Score |
Day 0, Day 7, Day 15, Day 30, Day 60 |
| Mean symptoms severity score of WURSS-24 Score |
Day 0, Day 7, Day 15, Day 30, Day 60 |
| Immunoglobulin G (IgG) Level |
Day 0,Day 60 |
| Immunity panel-CD3, CD4 & CD8 Count |
Day 0,Day 60 |
| WHO-Quality of Life (WHOQOL-BREF) |
Day 0,Day 60 |
| Inflammatory Biomarker-C-Reactive Protein (CRP) |
Day 0,Day 60 |
| Laboratory Safety Parameters |
Day 0,Day 60 |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2022 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This proposed study is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of KaraShieldTM versus placebo in improving the general immunity in otherwise healthy population aged between 18 to 60 years. The observed outcomes through primary and secondary endpoints results will be analysed to check the safety and efficacy of this synergistic herbal formulation. |