| CTRI Number |
CTRI/2020/06/025625 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
15/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Study of the effect of Siddha Treatment in addition to standard therapy in COVID-19 patients |
|
Scientific Title of Study
|
A Prospective, Multicenter, Randomized, Open-Label, Proof-of-Concept (PoC) Study to Evaluate the Efficacy and Safety of Siddha Treatment in Patients with Novel Coronavirus Infectious Disease (COVID-19) |
| Trial Acronym |
START (Siddha Treatment Accelerating Recovery from SARS-CoV-2 Test) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JEYA VENKATESH |
| Designation |
Chairman |
| Affiliation |
Kokila Siddha Hospital and Research Centre |
| Address |
Kokila Siddha Hospital and Research Centre
Madurai
27Jaihindpuram I Street
Madurai
Madurai
TAMIL NADU
625011
India |
| Phone |
|
| Fax |
|
| Email |
jeyavenkateshdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JEYA VENKATESH |
| Designation |
Chairman |
| Affiliation |
Kokila Siddha Hospital and Research Centre |
| Address |
Kokila Siddha Hospital and Research Centre
Madurai
27Jaihindpuram I Street
Madurai
Madurai
TAMIL NADU
625011
India |
| Phone |
|
| Fax |
|
| Email |
jeyavenkateshdrs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JEYA VENKATESH |
| Designation |
Chairman |
| Affiliation |
Kokila Siddha Hospital and Research Centre |
| Address |
Kokila Siddha Hospital and Research Centre
Madurai
27Jaihindpuram I Street
Madurai
Madurai
TAMIL NADU
625011
India |
| Phone |
|
| Fax |
|
| Email |
jeyavenkateshdrs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eminentlabs Business Solutions Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Eminentlabs Business Solutions Pvt Ltd |
| Address |
No.: 3466, TNHB, Avadi, Chennai-600054,
Tamilnadu, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrAVinoth Kumar |
Chengalpattu Govt Medical College & Hospital |
Government Medical College & Chengalpattu
Hospital,G.S.T. Road, Kancheepuram, Chengalpattu
Kancheepuram
TAMIL NADU |
044-27431221
mbbs.vinoth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- Chengalpattu Medical College. |
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 |
| Intervention |
1. Kabasura kudineer
2. Bramanandha bairavam |
1. Kabasura kudineer 60 ml twice daily (90 minutes before food - Morning 7.00 and evening 6.00) for 14 days
2. Bramanandha bairavam 100 mg thrice daily (30 minutes after food) with honey or ginger juice for 14 days
|
| Comparator Agent |
Standard Covid Treatment Protocol |
As Standard of care recommended by ICMR
A. Mild symptoms:
1. Tablet Oseltamivir 2. Antibiotics if needed (azithromycin + amoxicillin /clavulanic acid)
3. Paracetamol
B. Moderate symptoms
1. Oxygen supplementation
2. Antipyretics, antitussives, antibiotics as indicated
3. Metered Dose Inhaler preferred over nebulization
4. Hydroxychloroquine
5. Lopinavir/ Ritonavir (within 10 days of symptom onset) may be considered on case to cases |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females aged 18 to 75 years, both inclusive
2. Have laboratory confirmed COVID-19 disease
3. Asymptomatic patients (who are positive for SARS CoV-2 and with no symptoms) or meets clinical features of the following grades of severity (Appendix II):
a. Group 1: Suspect and confirmed cases clinically assigned as mild and very mild
Clinical criteria: Cases presenting with fever and/or upper respiratory tract illness (Influenza Like Illness, ILI).
b. Group 2: Suspect and confirmed cases clinically assigned as moderate
Clinical criteria: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30 breaths/minute, SpO2 90%-94%).
4. Agrees to practice contraception during the entire study treatment period and for 3 months after the last treatment of IMP is administered:
a. Using double barrier contraception,
b. or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the participant
Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential] and withdrawal are not acceptable methods of contraception.
5. Patients or their legal representatives have personally signed and dated the informed consent form (ICF) before completing any study-related procedure, which means before any assessment or evaluation that would not have formed a part of his/her normal medical care
6. Patients willing to adhere and comply with the protocol related procedures
7. Patients willing to take Siddha drug regimen for COVID-19
8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study drug |
|
| ExclusionCriteria |
| Details |
1. Patients with other viral pneumonia
2. Patients with severe or critical COVID-19 disease
3. Patients who have taken antibiotics/antivirals in the past 1 week
4. Patients with history of asthma, chronic obstructive pulmonary disease or any other chronic lung disease
5. Patients with any active malignancy
6. Patients who have received organ transplantation in the past 6 months or planning surgery
7. Patients who cannot take food or drugs orally
8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption
9. Patients who have severe underlying diseases that affects survival, including blood diseases, dyscrasia, active bleeding, severe malnutrition, etc
10. Patients with uncontrolled blood pressure (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg) or uncontrolled diabetes (HbA1C >7%)
11. Women patients who are pregnant or lactating, or patients (including male patients) having a pregnancy plan (including plans for sperm donation or egg donation)
12. Patients with allergic constitution, or patients allergic to investigational products
13. Patients positive for human immunodeficiency virus, Hepatitis B and Hepatitis C at screening
14. Patients whose alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal
15. Patients requiring Extracorporeal Life Support Program (ECLS), i.e. Extracorporeal Membrane Oxygenation (ECMO), Extracorporeal carbon dioxide removal (ECCO2R) or Registered Respiratory Therapist (RRT)
16. Critical patients with life expectancy <48 hours
17. Patients who are not suitable to participate in the study based on the investigator’s judgement
18. Patients who have participated in any clinical trial 30 days prior to screening
19. Clinically significant laboratory findings at screening |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients confirmed as negative for SARS-CoV-2 in 2 consecutive throat/nasal swabs (taken 24 hours apart) at Day 15/Day16. |
To compare the efficacy of Siddha drug regimen plus Standard of Care (SoC) with SoC alone in the treatment of Covid-19 positive patients. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety of Siddha drug regimen plus Standard of Care (SoC) with SoC alone in the treatment of Covid-19 positive patients. |
1. Time taken from patients to become asymptomatic from symptomatic
2. Mean viral load change from baseline at Day 15
3. Mortality rate
4. Length of hospitalization
Note: Hospitalization means patients who require parenteral [eg. Intravenous (IV)] medications or IV fluids, oxygen or ventilatory support. Mere isolation or quarantine inside the hospital premises will not be considered as hospitalization
5. Time to achieve National Early Warning Score (NEWS) equal to zero (Appendix III). |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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 2 |
|
Date of First Enrollment (India)
|
11/05/2020 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The COVID-19 infection is currently a global threat and the ways of dealing with it is less to known to the mankind. Different medicinal systems are being explored to find remedial measures for this new kind of infection. While traditional medicinal system like Siddha or Ayurveda is considered a treasure of India with an ample of classical literary evidences, the safety and effectiveness of these medicines are still under debate among both adherents and skeptics. Despite the fact that the remedies have been in use for hundreds of years, critics argue the claims of therapeutic efficacy of traditional medicine. However, in the present scenario, few tested Siddha formulations are being considered. These have been shown to have antiviral, antipyretic, antioxidant, anti-inflammatory properties. Presently, different aspects of conventional and alternative medicinal system are being explored to address COVID-19 pandemic. The alarming pace at which the infection spreads requires that the intervention minimizes the viral load and the minimizes the spread of infection. Antiviral drugs, Hydroxychloroquine, and antimicrobial drugs are presently being utilized in treating COVID-19 positive patients. However, no breakthrough has been achieved in addressing the issue of tackling the pandemic. As Siddha system is being explored in this context, it is prudent to look at the traditional formulations that are effective in treating viral infections, respiratory conditions, and effective in improving quality of life in affected patients. The investigational product have been tried for different viral infections (air borne, or arthropod borne), respiratory ailments such as cough, sore throat, congestion, difficulty in breathing, etc. In this study, the investigational product is given in addition to the standard of care in one of the two arms. The other arm will have only standard of care. Considering the gravity of the situation arising from COVID-19 infection, none of the patients will be deprived of the standard of care. In the first arm the Siddha formulation is given as an additional treatment. If the investigational product is effective, the patients in the first arm should show rapid relief from symptoms, and a better quality of life due to the treatment. |