| CTRI Number |
CTRI/2020/06/026231 [Registered on: 29/06/2020] Trial Registered Prospectively |
| Last Modified On: |
29/06/2020 |
| 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 effect of ayurvedic treatment for prevention and management of asymptomatic, mild and moderate cases of COVID-19. |
|
Scientific Title of Study
|
“To study the efficacy of add on Ayurvedic treatment to
the standard of care for prevention and management of asymptomatic, mild &
moderate cases 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 Rajkumar Nikalje |
| Designation |
Assistant Professor |
| Affiliation |
Symbiosis Medical College for Women and symbiosis university hospital and research centre |
| Address |
Department of Respiratory medicine, 5th floor, symbiosis medical college for women and symbiosis university hospital and research centre,
Lavale hill base, Gram: Lavale, Tal: Mulshi
Dist:Pune
Pune
MAHARASHTRA
412115
India |
| Phone |
9028560535 |
| Fax |
|
| Email |
nikalje.rajkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Shirodkar |
| Designation |
Ayurvedic Physician |
| Affiliation |
Symbiosis medical college for women and symbiosis university hospital and research centre, pune |
| Address |
c/o Dr. Shirodkars Health Solutions PL, S2/11, Devideep Society, NDA
Road, Bavdhan, Pune 411021
Pune
MAHARASHTRA
411021
India |
| Phone |
9822352497 |
| Fax |
|
| Email |
drjyotishirodkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Shirodkar |
| Designation |
Ayurvedic Physician |
| Affiliation |
Symbiosis medical college for women and symbiosis university hospital and research centre, pune |
| Address |
c/o Dr. Shirodkars Health Solutions PL, S2/11, Devideep Society, NDA
Road, Bavdhan, Pune 411021
Pune
MAHARASHTRA
411021
India |
| Phone |
9822352497 |
| Fax |
|
| Email |
drjyotishirodkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Symbiosis medical college for women and symbiosis university hospital and research centre, Lavale, pune
|
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
Ayush Bhawan, B Block, Gpo Complex, Ina, New Delhi, Delhi 110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 Vijay Natarajan |
Symbiosis University Hospital and Research Centre |
Department of respiratory medicine, 5th floor, Symbiosis medical college for women, Lavale Hill base, Gram-Lavale, Tal-Mulshi,
Pune Pin-412115
Pune
MAHARASHTRA |
9822251686
vijaynatarajan5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics committee, symbiosis international university |
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 |
For prevention regime-Standard of care |
Standard of care as per hospital protocol |
| Intervention |
For Prevention regime: Ayurvedic treatment |
1.Dietary recommendations and restrictions
2.Morning, empty stomach: 4 black resins boiled in one cupful of water
3.Decoction of cinnamon, dried ginger, black pepper and cardamom at 9.00 am
4.A cup of hot milk with 250 mg-500 mg of turmeric powder, 2 hours after dinner.
5.Sanshamanivati 250-500mg twice a day with water. |
| Intervention |
For Treatment regime- Ayurvedic treatment |
1.Tab TribhuvanKirti: 125mg-250mg + Tab. Sutshekhar: 250 mg+ SitopaladiChurna :
500 mg (Thrice a day with hot water for 14 days).
2.Samshamanivati 250-500 mg, (twice a day with hot water)
3.If dry cough is present, shunthiksheerpak will be given for 5-7 days in addition to
above treatment.
After this treatment, patients will be given the Ayurvedic regime prescribed for prevention regime for 28 days. |
| Comparator Agent |
For treatment regime- standard of care |
standard of care as per hospital protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Males or Females with age group of 18 years to 60 years.
Participants, ready to sign informed consent form
For Prevention Regime: Health care workers working in Hospital and are Negative for
COVID-19 test.
For treatment Regime: Asymptomatic, mild & moderate laboratory confirmed cases
of COVID-19 |
|
| ExclusionCriteria |
| Details |
1.Age below 18 years and above 60 years
2.Pregnant and lactating women
3. Seriously ill patients requiring intensive care
4 Subjects who have participated in another investigational drug or research study
within 30 days of screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Ayurvedic treatment on eradication of virus by testing for SARS-Co-V-2 by Real time PCR test
|
Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in inflammatory markers |
Day 1, 5, 10
|
| Resolution of signs and symptoms of COVID-19 |
day 3, 5, 10
|
| Duration of hospitalisation |
actual number of days of hospitalisation
|
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/07/2020 |
| 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)?
|
|
Brief Summary
|
In view of current outbreak of COVID-19 and lack of proven treatment in modern science, it is necessary to look for an alternative treatment. We propose add on Ayurvedic therapy for prevention of COVID-19 in COVID negative health care workers (n=50) and asymptomatic, mild and moderate COVID Positive cases (n=30). This is a proof of concept study. Participants of the study will be randomized in two arms: A. standard of care alone B. standard of care + Ayurvedic management. The outcomes of Ayurvedic treatment will be compared with allopathic standard of care in the same number of patients. So the study will be carried out in total 160 participants (100 COVID negative health care workers and 60 COVID positive cases). Prevention regime includes decoction of common spices, turmeric with milk, samshamani vati (tinospora cordifolia formulation) and black resins with hot water for 28 days. Management regime includes a combination of Tribhuvan kirti, sutshekhar and sitopaladi churna along with sanshamani vati for 14 days. This will be followed by prevention regime of 28 days. Pre-trial and post-trial COVID-19 antibodies, Hemogram, and inflammatory markers like ferritin, CRP will be compared. The analysis will be done to confirm the effectiveness of Ayurvedic medicine in preventing the health care workers from getting COVID-19 infection and for treatment of asymptomatic, mild & moderate Covid-19 positive cases. |