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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043570
Enrollment
120
Registered
2022-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Test product: KSM 66 Ashwagandha Capsule (300 mg), orally twice a day for 12 weeks Control Intervention1: Control Product: 300 mg Placebo capsule identical to KSM 66 Ashwagandha but wit

Sponsors

D Y Patil Medical College Hospital and Research Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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. 5. Subjects able to understand and complete the study questionnaires 6. Subjects who sign the informed written consent

Exclusion criteria

Exclusion criteria: 1. Patients aged below 18 years will be excluded. 2. Unwilling or unable to provide written informed consent, 3. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening. 4. Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.

Design outcomes

Primary

MeasureTime frame
Change in the health summary scores from Short Form SF-36 Quality of life questionnaire at the end of 12 weeks Timepoint: screening, week 4, week 8 and week 12

Secondary

MeasureTime frame
Change in scores for HAM-A at the end of 12 weeksTimepoint: screening, week 4, week 8 and week 12;Change in scores for HAM-D at the end of 12 weeks Timepoint: screening, week 4, week 8 and week 12

Countries

India

Contacts

Public ContactDr Deepak Langade

D Y Patil Medical College, Hospital and Research Center

deepak.langade@dypatil.edu9930550009

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026