| CTRI Number |
CTRI/2021/01/030355 [Registered on: 08/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the immunomodulatory support and overall health benefits of CUQ1720 and AK-CQAB-0520 in subjects with allergic symptoms |
|
Scientific Title of Study
|
A randomized, multi center, double blinded, placebo-controlled,parallel-group, comparative clinical study to evaluate the immunomodulatory support and overall health benefits of
CUQ1720 and AK-CQAB-0520 among population with Allergic Rhinitis having significant nasal conjunction, sneezing and
wheezing (upper respiratory infections). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamatha K |
| Designation |
Principal investigator |
| Affiliation |
Divakar’s Speciality Hospital |
| Address |
Department of General Medicine,Ground Floor,#220, 9th Cross, 2nd phase, JP Nagar, Next to Nilgiris,
Bangalore
KARNATAKA
560078
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drmamatharameshk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd,Malaidamthuruthu P.O Ernakulam Kerala, India |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt Ltd |
| Address |
Malaidamthuruthu P.O Ernakulam Kerala, India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Mamatha K |
Divakar’s Speciality Hospital |
Department of General Medicine,Ground Floor,#220, 9th Cross, 2nd phase, JP Nagar, Next to Nilgiris
Bangalore
KARNATAKA |
9482164779
drmamatharameshk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Divakars Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Allergic Rhinitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AK-CQAB-0520
|
Oral administration of AK-CQAB-0520 capsules twice a day for 84 days
|
| Intervention |
CUQ1720 |
Oral administration of CUQ1720 capsules twice a day for 84 days |
| Comparator Agent |
Placebo |
Oral administration of Placebo capsules twice a day for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects categorized as AR according to international guideline of American Academy of Allergy Asthma and Immunology
2. History of allergic rhinitis (persistent or seasonal) symptoms for at least two consecutive years.
3. No antibiotics use within 1 month prior to entering the study or during the study
4. If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the Study
5. Must be willing and able to give informed consent and comply with the study procedures |
|
| ExclusionCriteria |
| Details |
1. Asthmatic subjects who required long term inhaled or systemic corticosteroids within the previous 30 days
2. Subjects with nasal polyps and chronic respiratory tract infections
3. Subjects having symptoms of viral infection, including COVID-19 infection
4. Subjects with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome)
5. History of Recent blood donation, Immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection)
6. Concomitant medication/supplement which could affect the study
7. Any contraindication to blood sampling
8. Pregnant and lactating women
9. Subjects allergic to herbal products, nuts or any component of the study product
10. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
11. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Allergic Rhinitis (AR) Symptoms |
Day 0, Day 28, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Over all health benefits |
Day 0, Day 28, Day 84 |
| Over all Safety of the test products |
Day 0, Day 28, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 is a double blind, randomized (1:1:1), placebo controlled, parallel group, multi-centre, three
arm study. Male and female subjects (Age 18-45 years) meeting all inclusion and no exclusion
criteria after signing a written informed consent will be enrolled in the study.
After passing the eligibility criteria, subjects will be randomized into 3 treatment arms in 1:1:1 ratio
to receive Investigation products CUQ1720 , AK-CQAB-0520 or Placebo twice a day The subjects will undergo laboratory assessments for immune system function assessments. A 7-point visual analogue scale (VAS) will be used for assessing nasal, non-nasal symptom severity
and quality of life in the assessment of rhinitis severity.. Health-related quality of life will be
assessed by Short Form (SF)-12 questionnaire at the study site.The study is planned to be conducted in 3 visits over a period of 84 days |