None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 120 adults with Long COVID aged 18 to 65 years will be randomly assigned to receive a liquid herbal formula (SRS-MHT-44) daily or a placebo for 8 weeks. Changes in general wellbeing and quality of life will be assessed over time by administering several questionnaires. Moreover, changes in several biomarkers associated with inflammation, immunity, cardiovascular health, and general health will be evaluated over time. It is hypothesised that intake of the liquid herbal formula will lead to changes in Long-COVID related symptoms and blood markers associated with immunity, renal, cardiac and general health.
Interventions
Herbal formula (SHR-MHT-44) (15mls taken orally, three times daily (approximately 4 to 6hrs apart) with or without food, delivering 45 mls a day for 8 weeks). Adherence to liquid intake will be measured by bottle returns at weeks 4 and 8.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1) Adults aged between 18 and 65 years. 2) Participants have an adequate understanding of the clinical research, agree to follow study procedures, and provide an autonomously signed informed consent. 3) BMI between 18.5 and 30 kg/m2 4) Diagnosis or evidence of Long COVID comprising: a. An initial documented COVID-19 infection (positive Rapid Antigen Test/RT-PCR during acute infection, or clinical diagnosis by a doctor during or after acute illness) and for at least 3 months (greater than or equal to 12 weeks) prior to Screening, and b. A negative result on a COVID-19 rapid antigen test at the first in-person assessment, and c. Symptoms must have developed only after initial COVID infection, and d. Symptoms must be experienced for at least 3 months (greater than or equal to 12 weeks) after the initial COVID-19 infection, and e. After the telephone interview, the reported presence of at least 2 or more symptoms from 3 or more categories below MUSCULAR (CATEGORY 1) • Muscle aches and pains • Muscle weakness (e.g. don’t feel as strong physically, more effort than normal required for physical tasks or movement) • Impaired mobility (e.g. difficulty walking, legs struggling to support body weight) • Pain in joints RESPIRATORY (CATEGORY 2) • Coughing • Sneezing • Breathing difficulties (e.g. physically struggle to exhale, throat feels like it is closing up/squeezing sensation) • Shortness of breath? (e.g. can’t get enough air, feels like you’ve been running or after heavy exertion) • Lightheaded • Shallow breathing NEUROLOGICAL (CATEGORY 3) • Headache • Brain fog or signs of uncharacteristic ‘slowness’ or confusion (cognitive impairment) • Difficulty concentrating or focusing on a task • Gaps in short-term memory/being more forgetful than usual • Difficulty recalling information • Restlessness • Fatigue • Lack of energy and endurance • Lethargy • Easily get tired/exhaust yourself • Difficulty falling asleep/insomnia • Broken/interrupted sleep • Unsatisfying sleep • Cannot switch off your mind/racing thoughts • Trouble maintaining balance • Shooting nerve pain (neuropathy) • Visual disturbances or impaired vision post-infection CARDIOLOGICAL (CATEGORY 4) • Chest pain and/or tight chest • Fast heartbeat/pounding heart • Heart palpations • Poor blood circulation • Feeling cold (e.g. chills, cold hands and feet) • Dizziness • Pins and needles • ‘Heavy’ legs EMOTIONAL/PSYCHOLOGICAL (CATEGORY 5) • Low mood • Irritability • Anxiety • Nervousness • Easily moved to tears • Feelings of frustration • Feelings of helplessness • Depression • Worry GENERAL (CATEGORY 6) • Ongoing changes to sense of smell and taste • Loss of appetite • Weight loss • General malaise/feeling unwell • Flare-ups of old disease symptoms (e.g. latent viral infection) and/or inflammation of old injuries
Exclusion criteria
1) Active COVID-19 infection at visit 1 as evidenced by: a. A positive COVID-19 rapid antigen test (RAT) at visit 1 b. Medical evaluation confirming the presence of a body temperature greater than or equalt to 38ºC, and/or the onset of recent symptoms indicative of acute COVID-19 infection, including but not limited to a sore throat, runny nose, and loss of taste or smell. 2) Serious medical conditions that could introduce confounding in the interpretation of the treatment effect, or any serious medical condition that, in the opinion of the investigators, could complicate proper interpretation of the symptomatology as being of Long COVID. This includes, but is not limited to, the following: a. Cancer b. Diabetes (type I/insulin-dependent) c. Chronic Obstructive Pulmonary Disease (COPD) Stage II (moderate) or higher d. Chronic kidney disease (CDK Stage 3 or higher) e. Heart failure (NYHA Class II or higher) f. Autoimmune conditions 3) Participants with a non-serious illness but unstable condition as evidenced by: a. ECOG Performance Status greater than 2 b. Illness requiring hospitalisation in the last 3 months c. Therapeutic regimen has been inconsistent and irregular within the last 3 months d. Foreseeable evolution of the illness during the trial period will require treatment changes 4) Women who are pregnant or breastfeeding 5) Recently received a COVID-19 vaccine or booster or any other treatment for active/Long COVID in the last 30 days, or intend to do so during the study period. 6) Received any blood, plasma products or immunoglobulins within the past 60 days or intend to do so during the study period. 7) Received any immunosuppressive treatments within the past 90 days or intend to do so during the study period. 8) Taken part in other interventional studies within the last 90 days, or intend to do so during the course of the present study. 9) Have any surgery or treatments scheduled during the study period that, in the opinion of the researcher, may compromise adherence to the study 10) History of allergic reactions or hypersensitivity to the ingredients in the experimental product or placebo. 11) Currently taking, or recently changed, herbal and nutraceutical supplements reasonably expected to influence study measures. 12) Current smoker or heavy smoker in the last 3 years 13) A history of excessive alcohol consumption and/or drug abuse in the last 12 months 14) Planned major lifestyle change in the next 3 months
Outcome results
None listed