| CTRI Number |
CTRI/2021/08/035468 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy and safety precisely unveiled the comparative effectiveness of Sadangpaniya-phanta,Vayasathapana-kasya ghana tablet and Viyoshadi churna tablet in the treatment of COVID-19 |
|
Scientific Title of Study
|
A randomized, open label,controlled,pragmatic trial to evaluate the efficacy and safety of Sadangpaniya phanta,Vayasathapana-kasaya ghana tablet and Viyoshadi churna tablet in the treatment of COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Adhana |
| Designation |
Medical officer / Assistant Professor |
| Affiliation |
Gurukul Kangari parisar |
| Address |
Dr Rajesh Adhana Medical Officer/ Assistant Professor
Department of Toxicology
Gurukul parisar Uttrakhand Ayurved University Haridwar
Gurukul kangari parisar Uttrakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9412956506 |
| Fax |
|
| Email |
vaidadhanarajesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Adhana |
| Designation |
Medical officer / Assistant Professor |
| Affiliation |
Gurukul Kangari parisar |
| Address |
Dr Rajesh Adhana-Medical Officer/Assistant Professor
Department of Toxicology
Gurukul prisar Uttrakhand Ayurved University Haridwar
Gurukul kangari parisar Uttrakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9412956506 |
| Fax |
|
| Email |
vaidadhanarajesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Adhana |
| Designation |
Medical officer / Assistant Professor |
| Affiliation |
Gurukul Kangari parisar |
| Address |
Dr Rajesh Adhana Medical Officer/Assistant Professor
Department of Toxicology
Gurukul Kangari parisar Uttrakhand Ayurved University Haridwar
Gurukul kangari parisarUttrakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9412956506 |
| Fax |
|
| Email |
vaidadhanarajesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of Ayush Govt.of India |
| Uttrakhand Ayurved University Harrawala Dehradun |
|
|
Primary Sponsor
|
| Name |
Dr Rajesh Adhana |
| Address |
Gurukul Kangari Ayurvedic Prisar Uttrakhand Ayurved University Haridwar |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Asutosh Chohan |
Biomedical Wing Uttrakhand Ayurved University Harrawala Dehradun |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Adhana |
Uttrakhand Ayurved University |
Uttrakhand Ayurved University Hospital,Room No.001
Covid_19 Unite Harrawala Dehradun
Dehradun
UTTARANCHAL |
9412956506
vaidadhanarajesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Rishikul campus Uttrakhand Ayurved University Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B338||Other specified viral diseases. Ayurveda Condition: Covid-19, (2) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Sadangpaniya kwath ,Viyosadi churn tablet ,Vyasthapan kasay ghana tablet |
Sadangpaniya kwath ,Viyosadi churn tablet ,Vyasthapan kasay ghana tablet-INTERVENTION
Conventional allopathic treatment in mild case of Covid -19 confirm case |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient with mild symptoms of covid-19( Rapid test and RT-PCR) positive case will be enrolled. |
|
| ExclusionCriteria |
| Details |
Patient with moderate and sever Covid-19 infection having Pneumonia, Pregnant female patient with covid-19 infection will be excluded. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical recovery will be defined as sustained alleviation of illness based on symptom scores fever,cough,diarrhea,myalgia,dyspnea,all being absent. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic recovery as cough fever with on SpO2 decline greater than3% and respiratory rate more than 30 per minute and no feeling of weakness and no insomnia |
28 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/08/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet not |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Present study is a Randomized open label controlled pragmatic trial to evaluate the efficacy and safety of sadangpaniya phant, vayasthapana-kasay ghana tablet and viyosadi churana tablet in the treatment of Covid-19 virus infection -A deadly diseases. Epidemic is sweeping through the worldwide instantly. Billions of people lost their lives all over the world due to this single stranded RNA virus SARS-COV-2. there is no clinical interventions are being done worldwide .Consequently , it is necessary to draw on pluralistic knowledge system available globally. Combination of above mentioned three drugs are classical AYURVEDIC REMEDIES which will clinically investigated in mild case of Covid-!9 patient. As majority (80%) of Covid-19 cases present with mild symptom (cough,fever, diarrhoea, dyspnea, weakness).It is double arm comparative study with conventional interventions. Assessment will be done on parameters as time to wane the symptoms and diseases not to deteriorate, duration of hospitalization etc. |