| CTRI Number |
CTRI/2022/05/042782 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 Comparative Clinical Study to Evaluate the effect of BlaQmax on Subjects with Post COVID-19 symptoms. |
|
Scientific Title of Study
|
A Randomized, Multi Center, Double Blinded, Placebo-Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the effect of BlaQmax on Subjects with Post COVID-19 symptoms. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayashree S Seeri |
| Designation |
Principal Investigator |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of Community Medicine, BGS Global Institute of Medical Sciences #67, BGS Health and Education City, Uttarahalli road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drjayashree.ct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, #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 |
Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar
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 Jayashree S Seeri |
BGS Global Institute of Medical Sciences and Hospital |
Department of Community Medicine, BGS Global Institute of Medical Sciences #67, BGS Health and Education City, Uttarahalli road, Kengeri
Bangalore
KARNATAKA |
9482164779
drjayashree.ct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With History of post covid complications |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BlaQmax |
Oral administration of single dose of BlaQmax 200mg capsules everyday for 84 days |
| Comparator Agent |
Placebo |
Oral administration of single dose of 200mg Placebo capsules everyday for 84 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. COVID-19 patients with confirmed diagnosis based on a positive ICMR recognized SARS-Cov-2 test performed ≥ 4 weeks and ≤ 12 weeks.
2. Subjects having at least three of the Post COVID-19 symptoms including: [fatigue, headache, respiration problems (dyspnea or polypnea, cough), cognitive disorders (attention, memory, anxiety and depression), pain in joints, muscles and chest, gastrointestinal issues (diarrhea, nausea/vomiting, abdominal discomfort), sleep problems, cardiac issues (chest pain, heart palpitations, tachycardia, arrhythmia].
3. COVID-19 patients discharged after hospital admission.
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. Asymptomatic COVID-19 subjects
2. Post COVID-19 patients with symptoms longer than 3 months.
3. Subjects suffering from any uncontrolled chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease) or other underlying severe diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition)
4. History of any Immunodeficiency disease, Allergy, medication or supplement use that influences the immune system.
5.Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity and duration of post covid symptoms |
Day 0, Day 28 , Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Cognitive parameters |
Day 0, Day 84 |
| Change in hematolgical and biochemical parameters |
Day 0, Day 84 |
| Change in Biomarkers |
Day 0, Day 84 |
| Change in Questionnaire based assessments |
Day 0, Day 28 , Day 84 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
02/06/2022 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"NILL" |
|
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), placebo controlled, parallel group clinical study. Subjects having at least three of the Post COVID-19 symptoms [ meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study. The subject will undergo laboratory assessment, cognitive function tests, biomarker assessments, respiratory function assessment and fatigue assessment and other questionnaire based assessments at different time points The study is planned to be conducted in 3 visits over a period of 84 days. |