| CTRI Number |
CTRI/2022/06/043570 [Registered on: 29/06/2022] Trial Registered Prospectively |
| Last Modified On: |
15/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative study of Ashwagandha Standardized Extract for its effect on quality of life in patients during post-COVID19 period |
|
Scientific Title of Study
|
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 Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DYP-Pharm-RP-22; Version 1, dt. 05/10/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Uppe |
| Designation |
Professor and Head of Unit, Pulmonary Medicine |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Pulmonary Medicine, D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA
Thane
MAHARASHTRA
400706
India |
| Phone |
9769319554 |
| Fax |
|
| Email |
abhay.uppe@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Langade |
| Designation |
Professor and Head, Pharmacology |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA
Thane
MAHARASHTRA
400706
India |
| Phone |
9930550009 |
| Fax |
|
| Email |
deepak.langade@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Langade |
| Designation |
Professor and Head, Pharmacology |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA
Thane
MAHARASHTRA
400706
India |
| Phone |
9930550009 |
| Fax |
|
| Email |
deepak.langade@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Pvt Ltd, Shri Kartikeya Pharma
5-9-225, Sanali Estate,
Abids, Hyderabad - 500001 |
|
|
Primary Sponsor
|
| Name |
D Y Patil Medical College Hospital and Research Center |
| Address |
D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Uppe |
D Y Patil Medical College, Hospital and Research Center |
Room 103, First floor, Department of Pulmonary Medicine, D Y Patil Hopsital, D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA
Thane
MAHARASHTRA |
9769319554
abhay.uppe@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Padmashree Dr D Y Patil Medical College, Hospital and Research Center, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Product |
300 mg Placebo capsule identical to KSM 66 Ashwagandha but without active
ingredients, orally twice a day for 12 weeks
|
| Intervention |
Test product |
KSM 66 Ashwagandha Capsule (300 mg), orally twice a day for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the health summary scores from Short Form SF-36 Quality of life questionnaire
at the end of 12 weeks
|
screening, week 4, week 8 and week 12
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
|
screening, week 4, week 8 and week 12 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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) and HAM-D throughout the study period till week 12. |