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.
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/05/033576
- Lead Sponsor
- Advanced Enzyme Technologies Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of patients showing improvement on Chalder Fatigue Scale. 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] 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 Measures
Name Time Method 1.Proportion of patients showing improvement in mental fatigue. 2.Proportion of patients showing improvement in physical fatigue.
Trial Locations
- Locations (3)
Chirayu Medical College & Hospital
🇮🇳Bhopal, MADHYA PRADESH, India
Samvedna Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Swasthya Hospital
🇮🇳Bhopal, MADHYA PRADESH, India
Chirayu Medical College & Hospital🇮🇳Bhopal, MADHYA PRADESH, IndiaDr Rohit ParatePrincipal investigator9630033342rohitparate963@gmail.com