Comparative study of Ashwagandha for its effect on quality of life in patients during post-COVID19 period

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2021/08/035755
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-21
• Study Completion: 2022-04-04
• Last Update Posted: 2022-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.
• Subjects able to understand and complete the study questionnaires 6.
• 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, 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
Change in the health summary scores from Short Form SF-36 Quality of life (SF-36 QoL)questionnaire at the end of 12 weeks	screening, week 4, week 8 and week 12

Secondary Outcome Measures

Name	Time	Method
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

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, India

Dr Abhay Uppe

Principal investigator

9769319554

abhay.uppe@dypatil.edu