| CTRI Number |
CTRI/2021/08/035815 [Registered on: 19/08/2021] Trial Registered Prospectively |
| Last Modified On: |
17/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study Know the efficacy of Ayurveda Medicines in COVID 19 Positive Patients |
|
Scientific Title of Study
|
An open label controlled clinical study to evaluate the efficacy of Ayurveda Medicines - Sudarshana churna, Yestimadhu churna and Amrtharista as add on therapy on Symptomatology, Inflammatory Markers and RT-PCR in positive cases of COVID-19 - A Collaborative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Bhushan BL |
| Designation |
Professor, Department of Pulmonary Medicine |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pulmonary Medicine, Bangalore Medical College and Research Institute, K.R. Road, Fort, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
shashibhushanbmcri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishore Kumar Ramakrishna |
| Designation |
Professor of Ayurveda |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences, Bengaluru.
Bangalore
KARNATAKA
560029
India |
| Phone |
09845829174 |
| Fax |
|
| Email |
ayurkishore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore Kumar Ramakrishna |
| Designation |
Professor of Ayurveda |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences, Bengaluru.
Bangalore
KARNATAKA
560029
India |
| Phone |
09845829174 |
| Fax |
|
| Email |
ayurkishore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India 61-65, Institutional Area,
Opposite “D†Block, Janakpuri, New Delhi - 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Ministry of AYUSH, Government of India
61-65, Institutional Area, Opposite “D†Block,
Janakpuri, New Delhi - 110058 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
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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 |
| Dr Shashi Bhushan BL |
Victoria Hospital, Bangalore Medical College & Research Institute |
Department of Pulmonary Medicine, Bangalore Medical College and Research Institute, K.R. Road, Fort, Bengaluru
Bangalore
KARNATAKA |
9448239644
shashibhushanbmcri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College & Research Institute |
Approved |
|
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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. Ayurveda Condition: JVARAH, (2) ICD-10 Condition:B338||Other specified viral diseases. Ayurveda Condition: JVARAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sudarshana Churna, Reference: Ayurveda Pharmacopeia of India, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: Warm water), Additional Information: (2) Medicine Name: , Reference: Yestimadhu Churna, Route: Sharangadhara Samhita, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 32(2), Frequency: g, Bhaishajya Kal: tds, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: Warm Water(3) Medicine Name: , Reference: Amritharista, Route: Ayurveda Pharmacopeia of India, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(15), Frequency: ml, Bhaishajya Kal: tds, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: Water | | 2 | Comparator Arm (Non Ayurveda) | | - | Conventional Treatment | Tab. Ivermectin 12 mg 1 OD for 3 to 5 days or
Tab. HCQ 400 mg bid for 1 day followed by 400 mg OD for 4 days or
Tab. Favipiravir 1800 mg bid for 1 day followed by 800 mg bid for 6 days.
Tab. Zinc 50 mg OD
Tab. Vitamin C 500 mg tid
Tab. Paracetamol 500 mg (SOS)
Tab. Cetirizine 10 mg (SOS)
Anti-tussive Cough Syrup (SOS) |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients positive for COVID 19 confirmed by RT-PCR.
2) Patients with mild to moderate symptoms (NEWS 2 criteria). |
|
| ExclusionCriteria |
| Details |
Patients with
1) Diabetes Miletus.
2) Hepatic dysfunction
3) Renal dysfunction
4) Pulmonary dysfunction
5) Cardiovascular disease
6) Debilitating Neurological disorders.
7) Psychiatric illness.
8) Pregnant and Lactating.
9) Oxygen saturation less than 90%.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in
1) COVID 19 Symptomatology.
2) RT-PCR
3) IL-6 |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in
1) Hospital length stay.
2) Intensive care unit free days.
3) Oxygen saturation
4) Hospital Anxiety and depression Scale (HADS) |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2021 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized parallel group open label clinical study comparing the efficacy of add-on Ayurveda intervention (Sudarshana churna, Yestimadhu churna and Amritharista) and Conventional treatment daily for 2 weeks in 52 subjects (26 in each group) in COVID 19 positive patients that will be conducted at Victoria Hospital, Bangalore Medical College and Research Institute, Bengaluru. The primary outcome measures will be changes in COVID 19 symptomatology, RT-PCR and IL-6 at 2 weeks. The secondary outcome measures will be changes in hospital length stay, intensive care unit free days, oxygen saturation and Hospital Anxiety and depression Scale (HADS) at 2 weeks. |