Evaluation of Ashwagandha (Withania Somnifera) Standardized Extract for its effect on quality of life (QoL) in patients during post-COVID19 period: A Prospective, Randomized, Placebo-Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in the health summary scores from Short Form SF-36 Quality of life (SF-36 QoL)questionnaire at the end of 12 weeks
Study Overview
Brief Summary
A Prospective, Randomized, Placebo-Controlled Study of Ashwagandha Standardized Extract (KSM66) for its effect on quality of life (QoL) in patients during post-COVID19 period.
COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract. Some people who get COVID-19 have only mild symptoms. But for others, infection leads to pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more about any potential beneficial effects of ashwagandha in people who recover from COVID-19.The purpose of this study is to evaluate any potential benefits of Ashwagandha in patients who have recovered from COVID-19 in improving their overall quality of life.
The study assessments to be done by SP-36, Hamilton anxiety Rating scale (HAM-A) ,HAM-D throughout the study period till week 12 and CareFusion Vyntus CPX metabolic system (CareFusion Germany 234 GmbH) at screening and week 12.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects of either gender, aged 18 to 50 years
- •All adult patients aged ≥18 years who present to the site for follow-up OPD
- •Laboratory-confirmed COVID-19 infection with SARS-CoV-2
- •Subjects able to understand and complete the study questionnaires
- •Subjects who sign the informed written consent.
Exclusion Criteria
- •Patients aged below 18 years will be excluded.
- •Unwilling or unable to provide written informed consent,
- •Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.
- •Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
Outcomes
Primary Outcomes
Change in the health summary scores from Short Form SF-36 Quality of life (SF-36 QoL)questionnaire at the end of 12 weeks
Time Frame: screening, week 4, week 8 and week 12
Secondary Outcomes
- Change in scores for HAM-D at the end of 12 weeks(screening, week 4, week 8 and week 12)
- Change in scores for HAM-A at the end of 12 weeks(screening, week 4, week 8 and week 12)
- Changes in Cardio-Pulmonary Exercise Testing (CPET) results at the end of 12 weeks(screening and week 12)