| CTRI Number |
CTRI/2020/04/024731 [Registered on: 20/04/2020] Trial Registered Prospectively |
| Last Modified On: |
18/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Evaluate Preventive Effect of Ayurveda and Homeopathy Treatment in COVID 19 |
|
Scientific Title of Study
|
Evaluation of Effect of Composite AYUSH Treatment as Prophylaxis 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 Hemant Toshikhane |
| Designation |
Dean and Principal |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved, Parul University,
AP Limda, Tal Waghodia,
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Deshpande |
| Designation |
Professor, Kayachikitsa |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved, Parul University,
AP Limda, Tal Waghodia,
Vadodara
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Daga |
| Designation |
Lecturer, Shalya Tantra |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved, Parul University,
AP Limda, Tal Waghodia,
Vadodara
GUJARAT
391760
India |
| Phone |
9428563415 |
| Fax |
|
| Email |
ayurharish90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved |
|
|
Primary Sponsor
|
| Name |
Superintendent |
| Address |
Parul Ayurved Hospital,
Parul Institute of Ayurved, Parul University,
AP Limda, Tal Waghodia, Vadodara, Gujarat 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 Hemant Toshikhane |
Parul Ayurved Hospital |
Ground Floor, Parul Ayurved Hospital, Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia,
Vadodara
GUJARAT |
8469496525
drhemantt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers who have high chances of exposure to COVID 19 patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Samshamani Vati (500 mg twice daily after food with warm water for 15 days), Sudarshan Ghana Vati (250 mg thrice daily after food with warm water for 15 days), Khadiradi Vati (250 mg twice daily for chewing for 15 days), Murrchhita Tila Taila (for Nasya (nasal instillation) 2 drops in each nostril in morning and evening for 15 days), Aesenic Album 30 (4 tablets before lunch for 3 days) |
For 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are not suffering from active illness due to infecction at the time of inclusion |
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from active illness due to infection at the time of inclusion.
2.Subjects suffering from uncontrolled DM, HTN etc.
3. Subjects who are known cases of immune-compromised or autoimmune condition such as HIV.
4.Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19 during lockdown in March and April 2020 |
From Baseline till the end of 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of COVID 19 infection in study population |
From Baseline till the end of 15 days |
| Requirement of treatment for symptoms developed, if any, during study period |
From Baseline till the end of 15 days |
| Analysis of adverse events, if any |
From Baseline till the end of 15 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
24/04/2020 |
| 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="3"
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
|
The COVID 19 outbreak has been declared as pandemic by the world health organisation. In view of lack of precise treatment or vaccine, the incidence and mortality due to the infection remain high and are very high. Ayurveda explains many medications and treatments in the management of febrile illnesses (Jwara) and diseases of respiratory system (Pranavaha Srotsa) which are being practised since many years and are proven effective. Hence it is high time to evaluate its effect as a preventive measure in symptoms of respiratory system infection seen in COVID 19 patients. Ayurveda explains many medications and
treatments in the management of febrile illnesses (Jwara) and diseases of
respiratory system (PranavahaSrotsa) which are being practised since many years
and are proven effective. Hence it is high time to evaluate its effect as a
preventive measure in symptoms of respiratory system infection seen in COVID 19
patients. Rasayana is the Rejuvenation branch of Ayurvedic medicine. Rasayana
treatments were traditionally utilized after a period where the body was
warn-down or depleted. Rasayana therapies are also used to remedy old age,
before the term ‘anti-ageing’, there was Rasayana. Many classical formulations
mentioned in Ayurvedic classic are excellent Rasayana medicines which can be
used in treatment of various diseases including Jwara, Kasa, Kshaya.
SamshamaniVati, KhadiradiVati, Dashmoola katutrayadi GhanVati are such
medicines which can be useful in this condition. Nasya with AnuTaila in
PratimarshaMatra (2 drops) is a remedy mentioned in Dinacharya that has shown
beneficial effects in many URTI conditions. Arsenic album 30 a homeopathic
medicine that is claimed to be beneficial in prevention from COVID 19
infection. |