| CTRI Number |
CTRI/2020/09/027882 [Registered on: 17/09/2020] Trial Registered Prospectively |
| Last Modified On: |
17/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to Evaluate the effect of an Ayurvedic Regimen administered in (COVID – 19) Patients |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the effect of an Ayurvedic Regimen administered in nCoV-2 (COVID – 19) Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shirobhi Sharma |
| Designation |
Assistant Professor,Department of Medicine |
| Affiliation |
Subharti Medical College and Hospital |
| Address |
Subharti Medical College and Hospital, Subhartipuram, NH 58, Meerut bypass (Delhi Haridwar Road)
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9456206192 |
| Fax |
|
| Email |
shirobhisharma@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirobhi Sharma |
| Designation |
Assistant Professor,Department of Medicine |
| Affiliation |
Subharti Medical College and Hospital |
| Address |
Subharti Medical College and Hospital, Subhartipuram, NH 58, Meerut bypass (Delhi Haridwar Road)
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9456206192 |
| Fax |
|
| Email |
shirobhisharma@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Kapil |
| Designation |
Assistant Professor,Department of Pharmacology |
| Affiliation |
Subharti Medical College and Hospital |
| Address |
Subharti Medical College and Hospital, Subhartipuram, NH 58, Meerut bypass (Delhi Haridwar Road)
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7065529899 |
| Fax |
|
| Email |
gauravkapiljune@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Institute,Governed by Patanjali Research Foundation Trust Patanjali Yogpeeth Trust Haridwar Uttarakhand-249405
|
|
|
Primary Sponsor
|
| Name |
Patanjali Research Institute |
| Address |
Patanjali Yogpeeth Trust Haridwar Uttarakhand-249405
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Swami Vivekanand Subharti University |
Subhartipuram, NH-58, Meerut bypass (Delhi Haridwar Road) Uttar Pradesh- 250005
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGaurav Kapil |
COVID-19 Section,Subharti Medical College & Hospital |
Subhartipuram, NH-58, Meerut bypass (Delhi Haridwar Road) Uttar Pradesh- 250005
Meerut
UTTAR PRADESH |
7065529899
gauravkapiljune@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Subharti Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic Regimen |
Divya Swasari Vati 2 tablets orally with luke-warm water, thrice a day, half an hour before the breakfast, lunch and dinner.
Divya Coronil Tablet2 tablets orally with luke-warm water, thrice a day, half an hour after the breakfast, lunch and dinner.
Divya Anu Taila (For Nasal Therapy) 4 drops of Anu Taila in both the nostrils, once per day, relatively 1 hour before breakfast.
|
| Comparator Agent |
Placebo Group |
Placebo against Divya Swasari Vati
Placebo against Divya Coronil
Placebo Nasal drop aganist anu taila |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18- 60 years of both male and female gender.
Laboratory confirmed COVID-19 patients determined through (RT-PCR).
Patient consenting to participate in the study and follow instructions.
Agree to attend hospital for follow up on predetermined schedule.
|
|
| ExclusionCriteria |
| Details |
Laboratory confirmed COVID-19 asymptomatic cases.
Patients on parenteral nutrition.
Pregnant and lactating mothers and those who have pregnancy plan.
Person with serious critical illness like End stage liver or renal disease, Coronary artery disease, Stroke or Renal tubular acidosis.
Participants with any immunosuppressive medication or in an immune compromised state or hematological disease.Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To render proportion of patient showing clinical improvement in mild, moderate and severe COVID-19 cases.
Mean time (days) for clinical recovery.
|
Details will be recorded on Day 0 i.e. the day of admission (baseline), Day 3, Day 7 ,Day 14 and on one follow up visit on Day 28.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To restore health and reduction in serum viral load.
Rate of patients with negative SARS-CoV2 on nasal or throat swab RT-PCR test.
Reduction in increased immunological markers like IL6 and other relevant markers like quantitative CRP, Serum LDH, TLC.
• Drug related side effects and toxicity, and tolerability.
Health status improvement in Quality of life through WHO QOL bref questionnaire.
|
Details will be recorded on Day 0 i.e. the day of admission (baseline), Day 3, Day 7 ,Day 14 and on one follow up visit on Day 28.
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/09/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double-blind, parallel-group placebo-controlled interventional study. To combat the COVID-19 virus with Ayurveda, we discovered that natural phytochemicals in Ashwagandha, Giloy, and Tulsi indeed have the potentials to combat COVID-19 and its pathogenicity. The investigational regime comprises of Divya Coronil Tablets, Divya Swasari Vati which are oral tablets and the product is Anu tail which is a liquid dosage form in form of nasal drops.· To render the proportion of patients showing clinical improvement in mild, moderate and severe COVID-19 cases. The patients will be divided into 2 categories. Category I patients will receive standard COVID-19 treatment along with the experimental ayurvedic medicine while category II patients will receive standard COVID-19 treatment along with placebo.
Primary Endpoint:To get CT value of RT-PCR / RT- PCR negative. Secondary Endpoints:To get normal or near-normal values of important markers like CRP, IL6 and TNFα., Length of time to clinical improvement/disease progression. These details will be recorded on Day 0 i.e. the day of admission (baseline), Day 3, Day 7 and Day 14 or the day of discharge and on one follow up visit on Day 28.
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