| CTRI Number |
CTRI/2020/05/025161 [Registered on: 13/05/2020] Trial Registered Prospectively |
| Last Modified On: |
27/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the Effectiveness of herbal formulation - Aayudh Advance as a supplementary treatment for the Corona Virus 2019 (Covid-19) infected patients |
|
Scientific Title of Study
|
A Randomized and Comparative Study to assess Safety and Efficacy of Supplemental Treatment of a herbal formulation - Aayudh Advance comprising essential oils in patients with Corona Virus 2019 (Covid-19) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL/CSP/2020/002-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Dutt |
| Designation |
Principal Investigator |
| Affiliation |
Smt. NHL Municipal Medical College & SVPIMSR |
| Address |
Smt. NHL Municipal Medical College & SVPIMSR, Ellisbridge, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380006
India |
| Phone |
9426008607 |
| Fax |
|
| Email |
drjayeshjdutt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavdeep Ganatra |
| Designation |
Co-Principal Investigator |
| Affiliation |
Ganatra Ayurveda & Panchkarma Clinic |
| Address |
125, Advait complex, B/s Sandesh press, Vastrapur, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825497588 |
| Fax |
|
| Email |
vd.ganatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Rachchh |
| Designation |
Study Director |
| Affiliation |
Accuprec Research Labs Pvt. Ltd. |
| Address |
Opp. Pharmez,
Changodar - Bavla Highway,
Near Matoda Patia, Post: Matoda,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
9099981023 |
| Fax |
|
| Email |
manish.rachchh@accuprec.com |
|
|
Source of Monetary or Material Support
|
| Shukla Ashar Impex Pvt. Ltd., Rajkot |
|
|
Primary Sponsor
|
| Name |
Ms Shukla Ashar Impex Pvt Ltd |
| Address |
205-207, Orbit Plaza, Dr. Yagnik road, Rajkot – 360 001, Gujarat, India. |
| 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 Jayesh Dutt |
Smt. NHL Municipal Medical College & SVPIMSR |
Ellisbridge, Ahmedabad, Gujarat 380006
Ahmadabad
GUJARAT |
949426008607
drjayeshjdutt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Smt. NHL, Municipal Medical College, Ahmedabad (NHLIEC) |
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
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
As Standard treatment suggested by WHO |
As standard treatment suggested by WHO For Covid-19 Patients.
The study shall be from Patients initiation of treatment till complete recovery and discharge from the hospital. |
| Intervention |
Herbal formulation - Aayudh Advance |
Herbal formulation - Aayudh Advanced is a health supplement that helps boost immunity. This product is made from all-natural farm grown extracts. Each essential oil added into this concoction has been specially chosen for its individual immunomodulatory and protective characteristics. When mixed, these oils yield synergistic effect to protect the body from bacteria, viruses and fungi. Their potency is further increased when the mixture is converted into colloids. These colloids provide exponential efficacy that makes the product highly desirable health supplement, immunity booster, bactericide and virucide.
Dose is 10 ml three times a day orally before meal.
The study shall be from Patients initiation of treatment till complete recovery and discharge from the hospital. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Subject willing to sign informed consent.
2) Subject age group of 18 years and above of both gender.
3) All patients with COVID-19 RT-PCR positive (within 7 days)/ any Covid-19 test kit, admitted to the hospital / healthcare center will be eligible.
4) Patients who are having mild to moderate symptoms of Covid-19 disease and tested positive for Covid-19 test.
|
|
| ExclusionCriteria |
| Details |
1) Patient younger than18 years age.
2) Women who are pregnant or who intend to become pregnant for the next three months after taking the drug.
3) Patients allergic to type medications or any of the ingredient of the formulation.
4) Patients with a neurological history (seizures, epilepsy, etc.).
5) Patients with a previous history of psychiatric illnesses (depression, anxiety, suicide attempt).
6) Patients with severe cardiac pathologies or relevant chronic diseases that in the judgment of the clinician recommend the non-inclusion of the patient in the study.
7) Patients who are on artificial ventilation or oxygen supply.
8) Very severe patients of Covid 19.
9) Patients with severe hypertension, diabetes and other chronic diseases shall be excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Rate of Recovery
2) Symptom Resolution: Fever
3) Symptom Resolution: Cough
4) Symptom Resolution: Shortness of breath
|
Every 3-4 days from patient enrollment till recovery of patient and discharged from hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Questioning about any number of supplemental side effects observed.
2) Details of any adjunctive medication required during treatment due to supplemental treatment with herbal formulation - Aayudh Advance.
3) Total number of days till reaching the negative results for Covid-19.
|
Every 3-4 days from patient enrollment till patient recovery and discharged from hospital |
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/05/2020 |
| Date of Study Completion (India) |
15/06/2020 |
| 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
Modification(s)
|
Publication is under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study product, Aayudh Advance is a herbal liquid formulation containing mixtures of extracts and essential oils in water medium with sweetener. All the ingredients of formulation are mentioned in the scriptures of the Ayurveda. Further % recovery was 15.38 % more in case of Aayudh advance treatment group as compared to Standard of Care alone. So we can conclude that, test product “Aayudh Advanceâ€, when given concomitantly with standard of care, was 100% safe, more effective as virucidal to reduce viral load, devoid of any drug-drug interaction and increase recovery rate as compared to standard of care alone when tested in mild symptomatic COVID-19 patients.
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