| CTRI Number |
CTRI/2021/06/034433 [Registered on: 29/06/2021] Trial Registered Prospectively |
| Last Modified On: |
19/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on IMMUNODAATâ„¢ Botanical Ingredient, in Post Covid-19 recovery |
|
Scientific Title of Study
|
A Prospective, Randomized, Open Label, Two arm, Comparative Clinical Study to Evaluate the effect of IMMUNODAATâ„¢ Botanical Ingredient, in Post Covid-19 recovery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ELDR/LODAAT/2021/1, Version 2.0, 2nd June 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra B Mundhe |
| Designation |
Assistant Professor |
| Affiliation |
KVTR Ayurvedic College and Hospital Boradi |
| Address |
Department of Kayachikitsa,
OPD No. 5, Ground Floor, Department of Kayachikitsa, KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist. Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
9850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
Department of
Medical Services, 4th Floor, A 402-A,B,C, Jaswanti Allied center,
Ramchandra lane extn, Kachpada, Malad W, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
Department of
Medical Services, 4th Floor, A 402-A,B,C, Jaswanti Allied center,
Ramchandra lane extn, Kachpada, Malad W, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| LODAAT PHARMA
1415 West 22nd Street-Tower Floor,
Oak Brook, Illinois 60523
|
|
|
Primary Sponsor
|
| Name |
LODAAT PHARMA |
| Address |
1415 West 22nd Street-Tower Floor,
Oak Brook, Illinois 60523
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendra B Mundhe |
KVTR Ayurvedic College and Hospital, Boradi |
Department of Kayachikitsa,
OPD No. 5, Ground Floor, Department of Kayachikitsa, KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist. Dhule-425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
| Dr Shailesh Deshpande |
Parul Ayurveda Hospital, Parul University |
Department of Kaychikitsa, OPD no 106, Ground Floor, Parul Ayurveda Hospital, Parul University, P.O.Limba, Tal. Wagholia, Dist, Vadodara, Gujrat 391760
Vadodara
GUJARAT |
9763104451
dr.shaileshd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee on Human Research,(PIA-IECHR) |
Approved |
| Institutional Ethics Committee, KVTR Ayurvedic College, Boradi |
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 |
Conventional management (Standard of Care) |
Conventional management (Standard of Care)
Dosage and Treatment Duration: Subjects will be advised to take
Conventional management (Standard of Care) as prescribed / advised by concerned health authorities for 30 days
|
| Intervention |
IMMUNODAATâ„¢ Botanical Ingredient |
IMMUNODAATâ„¢ Botanical Ingredient Contains 250 mg elderberry extracts (Sambucus nigra L.)
Dosage and Treatment Duration: Subjects will be advised to take
IMMUNODAATâ„¢ Botanical Ingredient in a dose of 1 capsule twice daily orally for 30 days + Conventional management (Standard of Care) as prescribed / advised by concerned health authorities for 30 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who had mild to moderate symptoms [as per US-CDC classification) of COVID-19 (Ref: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html) (Mild symptoms up to mild pneumonia) and is recovered clinically.
2. Patients will be recruited from the day of clinical recovery till next 15 days and having Post Covid Symptoms as per https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects
3. Ready to provide written informed consent for participation in the study
4. Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt. / local health authority throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who had severe COVID-19 (moderate to severe pneumonia)
2. Subjects with post COVID 19 complications (those who had gone into severe type of COVID-19)
3. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study
4. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
5. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
6. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
7. Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study
8. Allergies, known to be allergic to IMMUNODAATâ„¢ Botanical Ingredient
9. Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparative changes in post-clinical recovery from COVID-19 (signs/symptoms/lab parameters)
2. Comparative assessment on blood related parameters like hematology, ESR and CRP from baseline to 30 days.
|
Day -3, Day 0, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in post-clinical recovery i.e. stress, anxiety, appetite, digestion, sleep, bowel movements physical energy and stamina
2. Change in health status assessment on WHO-QOL BRIEF
3. Global assessment of overall change as per the investigator and subjects
4. Assessment of tolerability of study drugs by physician and subjects at the end of the study.
5. Changes in vitals, occurrence of AE/SAE
6. Change in laboratory safety parameters
|
Day -3, Day 0, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2021 |
| Date of Study Completion (India) |
25/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET DONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It was a prospective, randomized, open label, two arm, comparative clinical study to evaluate the effect of IMMUNODAATâ„¢ Botanical Ingredient, in Post Covid-19 recovery. The study was conducted at two sites in India. As per computer generated randomization list, subjects were randomized to one of the two study groups in 1:1 ratio. Subjects from Group I were asked to take IMMUNODAATâ„¢ Botanical Ingredient in a dose of 1 capsule twice daily (250 mg capsule) orally for 30 days + Conventional management (Standard of Care) as prescribed / advised by concerned health authorities for 30 days and subjects from Group II were asked to take conventional management (Standard of Care) as prescribed / advised by health authorities for 30 days. The primary objectives of the study were to assess comparative changes in post-clinical recovery from COVID-19 (signs/symptoms/lab parameters) and comparative assessment on blood related parameters like hematology, ESR and CRP. The secondary objectives of the study were to assess changes in post-clinical recovery i.e. stress, anxiety, appetite, digestion, sleep, bowel movements physical energy and stamina, change in health status assessment on WHO-QOL BRIEF, global assessment of overall change as per the investigator and subjects, assessment of tolerability of study drugs by physician and subjects at the end of the study, changes in vitals, occurrence of AE/SAE and change in laboratory safety parameters on day -3, day 0, day 15 and day 30.
Results and Conclusion:
The present randomized, comparative clinical study concludes that Immunodaatâ„¢ played a significant role in reducing the symptoms of mild Post COVID-19 or long COVID-19. In this study, use of Immunodaatâ„¢ over 30 days helped to normalize the physical and mental symptoms that occurred due to long COVID-19. In addition, quality of life improved with the use of Immunodaatâ„¢. These potential effects can be attributed to the active phyto-constituents having potential anti-oxidant, nutritive, nervine tonic and adaptogenic effects of Immunodaatâ„¢. Immunodaatâ„¢ was found to be safe for consumption. Further studies with larger sample size involving blood markers can validate the results of the study. |