| CTRI Number |
CTRI/2021/07/034520 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Evaluation of Tab. AOIM – Z in managing after-effects of COVID – 19 infection |
|
Scientific Title of Study
|
Evaluation of Clinical Efficacy of Tab. AOIM – Z in managing after-effects of COVID – 19 infection – An Open Labelled, Single Arm, Prospective, Exploratory Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vedvati Bhapkar |
| Designation |
Assistant Professor |
| Affiliation |
D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Dept of Rasashastra and Bhaishajya Kalpana, D Y Patil deemed to be University School of Ayurveda Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9594830100 |
| Fax |
|
| Email |
drvedvati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vedvati Bhapkar |
| Designation |
Assistant Professor |
| Affiliation |
D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Dept of Rasashastra and Bhaishajya Kalpana, D Y Patil deemed to be University School of Ayurveda Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9594830100 |
| Fax |
|
| Email |
drvedvati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar Harit |
| Designation |
Dean & Professor |
| Affiliation |
D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Dept of Basic Principles, D. Y. Patil Deemed to be University School
of Ayurveda, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9322217607 |
| Fax |
|
| Email |
maheshkumar.harit@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Shree Dhootapapeshwar Limited |
|
|
Primary Sponsor
|
| Name |
Shree Dhootapapeshwar Limited |
| Address |
135 Nanubhai Desai Road Khetwadi Mumbai 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vedvati Bhapkar |
D. Y. Patil Ayurvedic Hospital , Special OPD |
D. Y. Patil Ayurvedic
Hospital - Special OPD
for Clinical Trials - D.
Y. Patil Deemed to be
University School of
Ayurveda, Nerul, Navi
Mumbai
Thane
MAHARASHTRA |
9594830100
drvedvati@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Ayurveda D. Y. Patil Deemed to be University, Navi Mumbai |
Approved |
| Institutional Ethics Committee School of Ayurveda D. Y. Patil Deemed to be University, 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. Ayurveda Condition: Post-COVID, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tab. AOIM-Z |
one tablet orally twice a day followed by Water (lukewarm water if possible) - for 90 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male or Female participants between the age group of 18 to 60 years (both inclusive), Participants with history of positive RT-PCR (Not less than 2 weeks to rule out active infection),3. Participants with symptoms of Post COVID-19 syndrome such as cough, fatigue, shortness of breath, anxiety, olfactory and gustatory dysfunction, Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements |
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating females, Participants hospitalized or in institutional quarantine, Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening, Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc., Participants taking steroid treatment and or any kind of immunosuppressive therapy, Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study, Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
a) Improvement in symptoms of Post COVID-19- such as Cough, Fatigue, Shortness of breath, Chest pain, Anxiety and olfactory and gustatory dysfunction
b) Improvement in Respiratory Function (FVC & FEV1)
c) Improvement in CRP levels
d) Improvement in SpO2 (sitting & after 6-min walk test)
e) Improvement in distance covered in 6-min walk test
f) Quality of life as assessed by Q-LES-Q-SF questionnaire |
Day 0, Day 45, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Incidence of re-infection of COVID-19, inquired at visits and weekly telephonic follow-up
b) Incidence and severity of allergic conditions (non-infective) leading to sneezing, running nose, sore throat etc, inquired at visits and weekly telephonic follow-up |
Day 0, Day 15, Day 45, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is terminated due to some unavoidable circumstances. |