PDF of Trial CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Fri, 24 Sep 2021 05:51:20 GMT)
CTRI Number CTRI/2020/07/026631 [Registered on: 16/07/2020] - Trial Registered Prospectively Last Modified On 05/09/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Siddha Study Design Single Arm Trial Public Title of Study Uses of herbal combination by taking it in hot water in covid 19 positive patients. Scientific Title of A multi centre clinical trial to study the safety and efficacy of herbal combination in covid 19 positive Study patients in Murugaa hospital and fertility centre Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr S Saravanan Trial Coordinator (multi-center study) Designation Chairman Affiliation MURUGAA HOSPITAL FERTILITY CENTRE Address room no 4 ground floor murugaa hospital fertility centre k chettipalayam dharapuram road tirupur 479 2b Murugaa hospital fertility centre K Chettipalayam Dharapuram road Tirupur 641604 Coimbatore TAMIL NADU 641604 India Phone 08778731043 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr S Saravanan Query) Designation Chairman Affiliation MURUGAA HOSPITAL FERTILITY CENTRE Address 479 2b Room no 4 Ground floor Murugaa hospital fertility centre K Chettipalayam Dharapuram road Tirupur 641604 479 2b Murugaa hospital fertility centre K Chettipalayam Dharapuram road Tirupur 641604 Coimbatore TAMIL NADU 641604 India Phone 08778731043 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr S Saravanan M B B S M MED in fam med C M C VELLORE Designation Chairman Affiliation MURUGAA HOSPITAL FERTILITY CENTRE Address 479 2b Room no 4 Ground Floor Murugaa hospital fertility centre K Chettipalayam Dharapuram road Tirupur 641604 479 2b Murugaa hospital fertility centre K Chettipalayam Dharapuram road Tirupur 641604 Coimbatore
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TAMIL NADU 641604 India Phone 08778731043 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Kumarans fertility centre now as Murugaa hospital fertility centre 479/2 b K Chettipalayam Dharapuram road Tirupur 641604 Primary Sponsor Primary Sponsor Details Name Kumarans fertility centre Address 479 2 b Murugaa hospital fertility centre Abirami nagar K Chettipalayam Dharapuram road Tirupur 641604 Type of Sponsor Private hospital/clinic Details of Secondary Name Address Sponsor Murugaa herbal research trust 479/ 2 b k Chettipalayam. Dharapuram road. Tirupur Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Johnson Amalraj johnson clinic 24/18 D Kennet cross 9894835530 road Madurai 625010 Madurai [email protected] TAMIL NADU Dr S Saravanan Murugaa hospital 479 2 b Abirami Nagar 08778731043 fertility centre K Chettipalayam Dharapuram road success3212000@gmai Tirupur 641604 l.com Coimbatore TAMIL NADU Dr S Mohan Kumar Pranav clinic 5 721 c Room no 2 08695846060 Aishwariyam Sri Sivasubramaniam [email protected] Gardens Govt Arts college east Udumalpet 642126 Coimbatore TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 14/07/2020 No committee Murugaa Hospital & Fertility centre Institutional ethics Approved 27/07/2020 No committee Pranav clinicv Johnson clinic Approved 25/07/2020 No Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition
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Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Patients Influenza due to other identifiedinfluenza virus with other manifestations Intervention / Type Name Details Comparator Agent Comparator Agent Not applicable Not applicable Intervention herbals powder 2 grams three times daily in hot water after food by oral route for seven days(This powder contains Zingiber officinale Piper nigrum Alpinia officinarum Melia Dubia Justicia adhatoda Anethum sowa Mollugo serviana Cuminum cyminum Curcuma longa) Inclusion Criteria Inclusion Criteria Age From 1.00 Day(s) Age To 80.00 Year(s) Gender Both Details From newborn to 80 years.patients admitted in hospital and in general public who are in home quarantine after testing corona(covid19) positive. Exclusion Criteria Exclusion Criteria Details Covid 19 positive pregnant patients And Carcinoma patients (Any type) Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints COVID 19 Positive Patients results will be turn one week negative after one week of taking herbal formulation by oral route for one week in hot water or in honey will be assessed by either clinicaly by evaluating their spO2 levels or by RT-PCR. Secondary Outcome Outcome Timepoints Patient will be symptomatically better after taking 5 days this herbal formula by estimating their spo2 levels Improvement in their breathing without any discomfort Target Sample Size Total Sample Size=30 Sample Size from India=30 Final Enrollment numbers achieved (Total)=0 Final Enrollment numbers achieved (India)=30 Phase of Trial N/A Date of First 19/07/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=5
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Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details uses of herbal powder in hot water taken after meals by oral route in covid 19 positive patients to improve their spo2 levels. It acts as a immunity booster . Brief Summary This herbal combination contains like Zingiber officinale Piper nigrum Alpinia officinarum Melia dubia Anethum sowa Mollugo serviana Justicia adhatoda Curcuma longa Cuminum cyminum in powder form to take it in hot water 2 grams three times per day after food
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