| CTRI Number |
CTRI/2020/04/024903 [Registered on: 28/04/2020] Trial Registered Prospectively |
| Last Modified On: |
07/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the effect of test product (AP-Bio®/KalmCold® capsules) in improving the immunity (Ability to protects the body against disease or other potential damaging foreign bodies) in healthy adults. |
|
Scientific Title of Study
|
A Prospective Open Label, Single Center, Single-Arm Trial to evaluate the efficacy of AP-Bio®/KalmCold® Capsules in enhancing the immunity and to evaluate its safety in healthy adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| iVRS-CD-20-008 Version: 01, Date 25 Mar 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajanna M |
| Designation |
Principal Investigator |
| Affiliation |
Surya Medical Centre |
| Address |
Surya Medical Centre, Ayurveda Department, Consulting General Physician Division, Room No 101 ground floor # 5, 8th cross, Mariyappa Road, Near Kullappa Circle
Bangalore
KARNATAKA
560084
India |
| Phone |
8660620501 |
| Fax |
|
| Email |
dr.rajanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethi S |
| Designation |
Medical Monitor |
| Affiliation |
InVitro Research Solutions Pvt. Ltd |
| Address |
InVitro Research Solutions Pvt Ltd, Clinical Development Department, Medical Monitoring Division,Room No 201 2nd floor 22, 23 Kodigehalli Main road sahakar nagar hebbal
Bangalore
KARNATAKA
560092
India |
| Phone |
9900515364 |
| Fax |
|
| Email |
preethi@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vijay Bhaskar |
| Designation |
Associate Director |
| Affiliation |
InVitro Research Solutions Pvt. Ltd |
| Address |
InVitro Research Solutions Pvt Ltd,Clinical Development Department, Clinical Operations Division,Room No 302 3rd floor 22, 23 Kodigehalli Main road sahakar nagar hebbal
Bangalore
KARNATAKA
560092
India |
| Phone |
636657282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| Health Care Company Natural Products,
Plot No. 5B, Veerasandra industrial Area, 19th K.M Stone, Hosur
Road Post, Electronic City Phase II, Electronic City, Bengaluru,
Karnataka 560100 |
|
|
Primary Sponsor
|
| Name |
Health Care Company Natural Products |
| Address |
Plot No. 5B, Veerasandra industrial Area, 19th K.M Stone, Hosur Road Post, Electronic City Phase II, Electronic City, Bengaluru, Karnataka 560100 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rajanna M |
Surya Medical Centre |
Surya Medical Centre, Ayurveda Department, Consulting General Physician Division, Room No 101 ground floor # 5, 8th cross, Mariyappa Road, Near Kullappa Circle
Bangalore
KARNATAKA |
8660620501
dr.rajanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shettys Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AP-Bio®/KalmCold® Capsules 100mg |
One capsule 100mg twice daily at fixed time in the day for 4 weeks (30 days) |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects aged between 18-60 years with BMI 18 to 30 kg/m2.
2.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the Investigator.
3.Devoid of any medication during last one month.
4.Subject provides written informed consent and comes for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1.Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
2.Subjects receiving influenza vaccination within 3 months before the screening examination.
3.Subjects with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic.
4.Subjects suffering from different diseases/disorders and/or having any kind of allergy, undergone surgery during last one year.
5.Subjects who have received organ transplant, chronic smokers, underlying conditions which might affect immunity.
6.Subjects who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening examination.
7.Subjects receiving antipsychotic medication within 3 months prior to the screening examination.
8.Subjects who is alcoholic or drug abuse suspected.
9.Subjects who have participated in other clinical trials within 3 months prior to the screening examination.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in NK cell count measured using flow cytometry |
Day -1, Day 3, Day 7 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in cytokines
Changes in T cell counts
Treatment Emergent Adverse events (AEs) frequency and severity |
Day -1, Day 3, Day 7 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2020 |
| Date of Study Completion (India) |
14/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total 30 healthy, adult, human subjects will be enrolled in the study. Single -Arm trial and followed up for one month treatment period . The primary objective to evaluate the efficacy of AP-Bio®/ KalmCold® capsules in enhancing the immunity in healthy adults. |