| CTRI Number |
CTRI/2021/05/033576 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
03/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to investigate the safety and efficacy of the health supplements ImmunoSEB and ProbioSEB CSC3 on patients suffering from COVID-19 Induced Fatigue/Post Viral Fatigue Syndrome.
|
|
Scientific Title of Study
|
A randomized multicentric Double Blind placebo controlled 2-Arm prospective study to investigate the safety and efficacy of the health supplements ImmunoSEB ProbioSEB CSC3 on patients suffering from COVID-19 Induced Fatigue Post Viral Fatigue Syndrome
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| COVID-007 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Parate |
| Designation |
Consultant- Department of medicine |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Department of medicine Ground Floor Room no. 43 Bhopal-Indore Highway Near Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9630033342 |
| Fax |
|
| Email |
rohitparate963@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Parate |
| Designation |
Consultant- Department of medicine |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Department of medicine Ground Floor Room no. 43 Bhopal-Indore Highway Near Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9630033342 |
| Fax |
|
| Email |
rohitparate963@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukul Maurya |
| Designation |
Director - ProClin Research Private Limited |
| Affiliation |
ProClin Research Private Limited |
| Address |
ProClin Research Private Limited.
Second Floor, IT Tower Plot No.29,Sector 142 Noida Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
07032802286 |
| Fax |
|
| Email |
mukul@proclinresearch.com |
|
|
Source of Monetary or Material Support
|
| Advanced Enzyme Technologies Ltd,5th Floor, ‘A’ wing, Sun Magnetica LIC Service Road, Louiswadi Thane (W) 400 604, India |
|
|
Primary Sponsor
|
| Name |
Advanced Enzyme Technologies Ltd |
| Address |
Sun Magnetica, A wing, 5th Floor,LIC Service Road, Louiswadi,Thane, Mumbai - 4000604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Parate |
Chirayu Medical College & Hospital |
Department of Medicine, Ground floor, Room no. 43, Bhopal-Indore Highway, Near Bairagarh
Bhopal
Bhopal
MADHYA PRADESH |
9630033342
rohitparate963@gmail.com |
| Dr Monica Gupta |
Samvedna Hospital |
Department of Medicine, B27/88G, Samvedna Hospital,Ravindrapuri, Varanasi
Varanasi
UTTAR PRADESH |
9415336322
Monicag4@yahoo.com |
| Dr Kuldeep Katariya |
Swasthya Hospital |
Department of Medicine, First Floor, Room no. 8, Narayan Nagar, Hoshangabad Road, Bhopal
Bhopal
MADHYA PRADESH |
7777888008
kuldeepkatariya3@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Samvedna Hospital Ethics Committee |
Approved |
| Vision Independent Ethics Committee |
Approved |
| Vision Independent Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ImmunoSEB ProbioSEB CSC3 |
ImmunoSEB + ProbioSEB CSC3: 2 capsules ImmunoSEB bid (500 mgs) + 2 capsules ProbioSEB CSC3 (5 billion CFUs) od for 14 days |
| Comparator Agent |
Placebo |
Maltodextrin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Subjects will be included in the study if they meet all of the following criteria:
1.Provides written informed consent
2.Male or non-pregnant, non-lactating female aged ≥ 18 and ≤ 75 years (both inclusive)
3.RT-PCR confirmed diagnosis of Covid-19 at any time followed by an RT-PCR negative test
4.Patients who are experiencing fatigue and muscle weakness
5.Able to take the drug orally and comply with study procedures
6.Women of childbearing potential must have a negative urine pregnancy test prior to study entry |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
1.Patients with severe to critical type of health condition as stratified below:
2.Clinical stratification:
3.Severe type: meeting any of the following criteria:
(a)Respiratory distress, RR≥30 times/min
(b)Finger oxygen saturation ≤90% in resting state
(c)Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation (FiO2)≤300mmHg.
4.Critical type: meeting any of the following criteria:
(a)Respiratory failure occurs and mechanical ventilation is required;
(b)Patients go into shock;
(c) ICU is needed for other organ failure.
5.Other viral pneumonia Patients who can not take food or drugs due to coma or intestinal obstruction
6.Consumption of other oral probiotic supplements during the trial
7.Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
8.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period
9.Allergic to systemic enzyme supplements.
10.Imminent death in the opinion of the clinical team
11.Patients with Hb less than 8 mg/dl
13.Patients who have participated in any other clinical study within 2 weeks prior to randomization;
14.The investigator concludes that the patient is not suitable for the study.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Proportion of patients showing improvement on Chalder Fatigue Scale.
2. Proportion of patients showing Improvement in mental Fatigue on CFQ. |
1.Proportion of patients showing improvement in physical Fatigue on CFQ [Time Frame: Day 14]
2.Proportion of patients showing Improvement in mental Fatigue on CFQ [Time Frame: Day 14]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Proportion of patients showing improvement in mental fatigue.
2.Proportion of patients showing improvement in physical fatigue.
3.Proportion of patient requiring additional therapy for fatigue.
4.Number of AEs and SAEs.
|
1.Proportion of patients showing improvement [Time Frame: Day 4]
2.Proportion of patients showing improvement [Time Frame: Day 8]
3.Proportion of patients showing improvement [Time Frame: Day 11]
4.Proportion of patients showing improvement [Time Frame: Day 14]
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/05/2021 |
| 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="0"
Days="14" |
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)?
Response - NO
|
|
Brief Summary
|
Several long-term health consequences are seen in patients with COVID-19, with some symptoms persisting for months after resolution of the infection. Among these symptoms, fatigue is the most persistent and debilitating. Over 53% of patients assessed approximately 2 months after onset of the first COVID-19 symptoms reported fatigue in a previous study. In another study, 48% of participants met the definition for fatigue at least 6 weeks post discharge, and this was not associated with severity of initial infection . According to the World Health Organization, people suffering from chronic fatigue are amongst those who may require rehabilitation to manage the after-effects of COVID-19 . Unfortunately, there is no specific medication for post-viral fatigue syndrome. Based on the data from other studies on ImmunoSEB and ProbioSEB CSC3, we hypothesized that a combination of therapeutic enzymes (ImmunoSEB) and probiotics (ProbioSEB CSC3) would be efficacious in the treatment of post COVID-19 fatigue. Thus, we designed this randomized, placebo-controlled prospective trial as an exploratory study to demonstrate the safety and efficacy of this supplemental regimen. |