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CTRI Number  CTRI/2020/08/027499 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 03/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Role of siddha medicine in the management of covid -19 
Scientific Title of Study   “An Open Clinical Trial to Evaluate the Safety & Efficacy of Siddha Sastric Medicines – Fixed Regimen in COVID-19 Positive asymptomatic mild or moderate cases with reference to the Siddha guidelines of COVID-19 management Ministry of AYUSH Govt of India at SIDDHA COVID CARE CENTER Sri Arcot Mahalakshmi Nursing College Campus Vilappakkam Ranipet District Tamilnadu  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRASUGANYA 
Designation  Asst Medical Officer (SIDDHA) 
Affiliation  DEPARTMENT OF INDIAN MEDICINE AND HOMEOPATHY 
Address  siddha wing,Govt Headquarters Hospital, Walaja.
Anna Hospital Campus, Arumbakkam, Chennai
Vellore
TAMIL NADU
632513
India 
Phone    
Fax    
Email  drsuganyamd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrASuganya 
Designation  Asst Medical Officer (SIDDHA) 
Affiliation  DEPARTMENT OF INDIAN MEDICINE AND HOMEOPATHY 
Address  siddha wing,Govt Headquarters Hospital, Walaja.
Anna Hospital Campus, Arumbakkam, Chennai
Vellore
TAMIL NADU
632513
India 
Phone    
Fax    
Email  drsuganyamd@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRASUGANYA 
Designation  Asst Medical Officer (SIDDHA) 
Affiliation  DEPARTMENT OF INDIAN MEDICINE AND HOMEOPATHY 
Address  Siddha wing, Govt Headquarters Hospital Walaja.
Anna Hospital Campus, Arumbakkam, Chennai
Vellore
TAMIL NADU
632513
India 
Phone    
Fax    
Email  drsuganyamd@gmail.com  
 
Source of Monetary or Material Support  
Mrs.Divyadharshini IAS, District Collectorate , Ranipet. 
 
Primary Sponsor  
Name  MrsDivyadharshini IAS 
Address  District Collectorate, Ranipet. 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Suganya  Siddha Covid Care Centre, Vilappakkam  Sri Arcot Mahalakshmi Nursing College Campus Vilappakkam
Vellore
TAMIL NADU 		 6382699056

drsuganyamd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GSMC CHENNAI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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. Kaba Sura Kudineer Chooranam – Decoction – Two times daily before 30 min of meals for 7 days 2. Adathodai manapagu – 10 ml –Twice daily with warm water after meals for 7 days 3. Amukkara Chooranam Mathirai 500 mg – 2 tablet - Three times daily after meals for 7 days with warm water 4. Thaleesadhi vadagam Mathirai 500 mg – 2 tablet – Three times daily after meals Chewable for 7 days with warm water 5. Brammanandha bairavam 100 mg – 2 pills - Two times daily after meals for 7 days with ginger juice/honey.  1. Kaba Sura Kudineer Chooranam – Decoction – Two times daily before 30 min of meals for 7 days 2. Adathodai manapagu – 10 ml –Twice daily with warm water after meals for 7 days 3. Amukkara Chooranam Mathirai 500 mg – 2 tablet - Three times daily after meals for 7 days with warm water 4. Thaleesadhi vadagam Mathirai 500 mg – 2 tablet – Three times daily after meals Chewable for 7 days with warm water 5. Brammanandha bairavam 100 mg – 2 pills - Two times daily after meals for 7 days with ginger juice/honey. one week dosage, oral route of administration 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  S.No Parameter
1. Adult Male/Female subjects above the age of 18 years
2. COVID -19 Positive as determined by RT-PCR
3. Willing to provide written/digital informed consent.
4. COVID - 19 Positive with no clinical signs
5. COVID - 19 Positive with mild symptoms – Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever, loss of smell, loss of taste
6. COVID - 19 Positive with moderate symptoms – Fever with cough, breathlessness but respiratory rate <24 per minute and Oxygen saturation > 95% at rest
 
 
ExclusionCriteria 
Details  S. No Parameter
1. Pregnant and Lactating females
2. COVID - 19 Positive with Severe symptoms – Respiratory distress (>24 breath per minute), Oxygen saturation < 95% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure
3. Chronic Renal Failure requiring dialysis (eGFR < 30)
4. Known cases of uncontrolled Diabetes (>9% HbA1c)
5. Known cases of stage 3 Hypertension (> 160/100 mmHg)
6. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
7. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.
8. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
9. Subjects who are participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
10. Subjects with bleeding disorders and severe anemia (Hb <7 g/dL)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Viral load of SARS-CoV-2 at the end of treatment
Reduction in clinical symptoms like fever, cough and breathlessness
(1. Fever: ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic ;
(2. Respiratory rate - ≤24/minute on room air;
(3. Cough - mild or absent on a patient reported scale (cough symptoms score ≤ 2 points)
 		 one week
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in incidence of complications
Reduction in hospital time
Laboratory markers (Laboratory Markers In Covid-19 Patients )
Adverse events/effects
 		 one week 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   05/09/2020 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   We are planning to conduct a clinical trial to know the safety and efficacy of siddhha medicine fixed regimen in covid positive patients 
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