Comparative study of Ashwagandha Standardized Extract for its effect on quality of life in patients during post-COVID19 period
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2022/06/043570
- Lead Sponsor
- D Y Patil Medical College Hospital and Research Center
- 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. Somepeople who get COVID-19 have only mild symptoms. But for others, infection leads topneumonia, respiratory failure, and, in some cases, death. Researchers want to learn moreabout 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 patientswho 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) and HAM-D throughout the study period till week 12.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
- Subjects of either gender, aged 18 to 50 years 2.
- All adult patients aged ≥18 years who present to the site for follow-up OPD 3.
- Laboratory-confirmed COVID-19 infection with SARS-CoV-2 4.
- Patients who agree to follow-up for up to six months.
- Subjects able to understand and complete the study questionnaires 6.
- Subjects who sign the informed written consent.
- Patients aged below 18 years will be excluded.
- Unwilling or unable to provide written informed consent, 3.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method at the end of 12 weeks screening, week 4, week 8 and week 12 Change in the health summary scores from Short Form SF-36 Quality of life questionnaire screening, week 4, week 8 and week 12
- Secondary Outcome Measures
Name Time Method Change in scores for HAM-A at the end of 12 weeks screening, week 4, week 8 and week 12 Change in scores for HAM-D at the end of 12 weeks
Trial Locations
- Locations (1)
D Y Patil Medical College, Hospital and Research Center
🇮🇳Thane, MAHARASHTRA, India
D Y Patil Medical College, Hospital and Research Center🇮🇳Thane, MAHARASHTRA, IndiaDr Abhay UppePrincipal investigator9769319554abhay.uppe@dypatil.edu