| CTRI Number |
CTRI/2020/08/027477 [Registered on: 31/08/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of safety and efficacy of T-AYU-HM Premium and Onion steam vaporization/nebulization in Covid-19 patients. |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of T-AYU-HM Premium and Onion Steam vaporisation/nebulization in Covid-19 patients (mild to moderate) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul M Desai |
| Designation |
Proprietor |
| Affiliation |
Dhanvantari Clinic, Ayurveda health care and research center |
| Address |
Room no: 301, Ayurveda, Shreeji Desai market,
Sardar Chowk
Vyara-394650,
Gujarat.
India
Surat
GUJARAT
394650
India |
| Phone |
9879031621 |
| Fax |
|
| Email |
dratuldesai@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul M Desai |
| Designation |
Proprietor |
| Affiliation |
Dhanvantari Clinic, Ayurveda health care and research center |
| Address |
Room no: 301, Ayurveda, Shreeji Desai market,
Sardar Chowk
Vyara-394650,
Gujarat.
India
Surat
GUJARAT
394650
India |
| Phone |
9879031621 |
| Fax |
|
| Email |
dratuldesai@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemshree Desai |
| Designation |
MD |
| Affiliation |
ATBU Harita Pharmaceuticals PVT LTD |
| Address |
ATBU Harita Pharmaceuticals Pvt ltd.
Room No:110, Shreeji Desai Market
Sardar Chowk
Vyara
Surat
GUJARAT
394650
India |
| Phone |
9558054500 |
| Fax |
|
| Email |
hemshree94@gmail.com |
|
|
Source of Monetary or Material Support
|
| ATBU Harita Pharmaceuticals Pvt ltd.
110, Shreeji Desai Market, Sardar Chowk Vyara - 394650, Gujarat, India |
| Dhanvantari Clinic, Ayurveda Health Care and Research Center
301, Shreeji Desai market, Sardar Chowk Vyara-394650, Gujarat. India
|
|
|
Primary Sponsor
|
| Name |
Dhanvantari Clinic Ayurveda Health Care and Research Center |
| Address |
Shreeji Desai Market, Vyara-394650, Gujarat. India
|
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ATBU Harita Pharmaceuticals Pvt ltd |
Vyara,Gujarat,India.
Email: atbuharita@gmail.com |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Desai |
Dhanvantari Clinic, Ayurveda Health Care and Research Center |
Shreeji Desai Market, Vyara-394650, Gujarat. India
Surat
GUJARAT |
9879031621
dratuldesai@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DivyajyotiTrust |
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 |
NA |
NA |
| Intervention |
Onion steam vaporization/nebulisation
|
Nasally OD for 21 days |
| Intervention |
Tablet T-AYU-HM Premium |
600mg orally BD for 21 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-80 years,
2. Both male and female
3. Mild to Moderate cases under home quarantine.
4. Willing to perform onion vaporization/nebulization
once a day
5. Patients able to consume oral formulations.
6. Willing to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Require mechanical ventilation
2. Unable to perform onion vaporization/nebulisation once a day.
3. Having serious stages illness
4. Pregnant/lactating women
5. Children below 18 years age
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Total number of participants with improvement in clinical symptoms – fever, Cough, Fatigue, Shortness of breath, Expectoration, Myalgia, Rhinorrhoea, Sore throat, Diarrhoea, Loss of smell (anosmia), Loss of taste (ageusia).
2. Total number of participants with resolution of clinical symptoms fever, Cough, Fatigue, Shortness of breath, Expectoration, Myalgia, Rhinorrhoea, Sore throat, Diarrhoea, Loss of smell (anosmia), Loss of taste (ageusia). |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Oxygen requirement of patients
2. Improvement in oxygen saturation
3. Improvement in respiratory rate
4. Improvement in haematological parameters
5. Improvement in the level of other inflammatory markers CRP, ESR, LDH
|
Baseline
5th day
21th day
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
03/09/2020 |
| Date of Study Completion (India) |
08/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
doi:10.25004/IJPSDR.2022.140212.
Desai, A., K. Desai, H. Desai, C. Desai, and R. Desai. “Evaluation of the Safety and Efficacy of T-AYU-HM Premium and Onion Steam Inhalation in Mild to Moderate Covid-19 Patients”. International Journal of Pharmaceutical Sciences and Drug Research, Vol. 14, no. 2, Mar. 2022, pp. 233-7 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a single arm, open label trial to evaluate the safety and efficacy of T-AYU-HM Premium 600 mg BD for 21 days and Onion steam vaporization/nebulization OD for 21 days in patients with COVID 19 that will be conducted at Dhanvantari Clinic, Ayurveda Health Care and Research Centre in India. The primary outcome measures will be improvement in clinical symptoms - cough, fever with or without chills, difficulty in breathing, headache, sore throat and resolution of clinical symptoms by the end of the treatment. Secondary outcomes will be reduction in oxygen requirement of patients, improvement in oxygen saturation, improvement in respiratory rate, improvement in hematological parameters, improvement in the level of inflammatory markers. |