CTRI Number	CTRI/2020/06/025590 [Registered on: 03/06/2020] Trial Registered Prospectively
Last Modified On:	16/10/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Modification(s)	A clinical trial to evaluate safety and efficacy of polyherbal capsule Astha-15 used as an add on therapy with standard care of therapy as an immunity booster in the suspected and COVID-19 diagnosed patients.
Scientific Title of Study	A Multi-centric, Double blind, Randomized, Comparative, Parallel-group, Placebo-controlled, Phase III clinical trial to evaluate the efficacy and safety of polyherbal capsule Astha-15 used as an add on therapy with standard care of therapy as an immunity booster, anti-cough, expectorant, anti inflammatory, cardio-protective, hepato-protective, broncho-protective in the suspected and COVID-19 diagnosed patients.
Secondary IDs if Any	Secondary ID  Registry  DAL/CT/001/AST/2020 Version No. 1.0, dated 23rd April 2020  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Mukesh Kumar  Address  A-19, 1st floor, Street No.-3, Gurunanak Pura, Laxmi Nagar East DELHI 110092 India  Phone  9873038019   Fax     Email  mukesh@rahelife.com
Details Contact Person Scientific Query	Name  Mukesh Kumar  Address  A-19, 1st floor, Street No.-3, Gurunanak Pura, Laxmi Nagar East DELHI 110092 India  Phone  9873038019   Fax     Email  mukesh@rahelife.com
Details Contact Person Public Query	Name  Mukesh Kumar  Address  A-19, 1st floor, Street No.-3, Gurunanak Pura, Laxmi Nagar East DELHI 110092 India  Phone  9873038019   Fax     Email  mukesh@rahelife.com
Source of Monetary or Material Support	Dalmia Centre for Research and Development
Primary Sponsor	Name  Dalmia Centre for Research and Development  Address  2nd Floor, A-48, Phase 1, Sector-2, Noida, Uttar Pradesh-201301, India  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 4   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr A Gopal Rao  Government Medical College & Government General Hospital (Old RIMSGGH)  Department of General Medicine, Srikakulam-532001, Andhra Pradesh Srikakulam   9440122790 drgopalraoa@gmail.com  Dr Amulya Bhati  Jaipur National University Institute for Medical Sciences and Research  Department of Respiratory Medicine, Jagatpura, Jaipur, Rajasthan 302017 Jaipur   7597562146 advisoroffice@jnujaipur.ac.in  Dr Vinod Kumar  Maulana Azad Medical College  Department of Orthopedics, Bahadur Shah Zafar Marg, New Delhi-110002 Central   9968604321 drvk706@gmail.com  Dr Prastita P Kshirsagar  Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital  Department of Medicine, Old Thane, Belapur road, Kalwa, Thane- 400605 Thane   9867936579 prasitapk@yahoo.co.in
Details of Ethics Committee Modification(s)	No of Ethics Committees= 4   Name of Committee  Approval Status  Institutional Clinical Ethics Committee, Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital  Approved  Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMSGGH)  Approved  Institutional Ethics Committee, JNUIMSRC  Approved  Institutional Ethics Committee, Maulana Azad Medical College  Submittted/Under Review
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere  Patients  Diseases of the respiratory system
Intervention / Comparator Agent	Type  Name  Details  Intervention  Astha-15 capsule  Two capsules to be taken orally twice a day. Two capsules after breakfast and two capsules after dinner with standard care of therapy  Comparator Agent  Placebo  Two capsules to be taken orally twice a day. Two capsules after breakfast and two capsules after dinner with standard care of therapy
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  50.00 Year(s) Gender  Both  Details  1. Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures. 2. Non-ICU patients suspected and diagnosed of COVID-19 diseases (In hospital isolation / quarantine ward). 3. Subjects having stable common respiratory associated disorders like Flu & common cold, allergic rhinitis, asthma and COPD.
ExclusionCriteria	Details  1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form. 2. Subject with positive pregnancy test as confirmed by urine dipstick test and who is planning to become pregnant within the study duration/lactating mothers. 3. Patients having psychiatric, musculoskeletal or cardiovascular diseases. 4. Patients suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, congestive heart failure, hepatic dysfunction, neurological disorders and diarrhoeal disorders. 5. Patients having a haemoglobin level <10 g/dl. 6. Patients having serious or unstable respiratory and its associated disorders. 7. Use of systemic corticosteroid therapy (this may affect peripheral muscle function). 8. Thyrotoxicosis, or diabetes treated with insulin. 9. Subjects having BMI less than 18.
Method of Generating Random Sequence	Other
Method of Concealment
Blinding/Masking	Participant, Investigator and Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  1. Changes in scores of the St. George Respiratory Questionnaire from baseline to EOT visit. 2. Changes in scores of the Leicester Cough Questionnaire from baseline to EOT visit.  Day -2 to -1, Day 1, Day 14, Day 28 (End of Treatment), Day 35 (Follow-up)
Secondary Outcome	Outcome  TimePoints  1. Changes in scores of Quality of life Questionnaire from baseline to EOT visit. 2. Evaluation and comparison of subjects of both group not attaining ICU rather gaining potential to get recovered during the study treatment.  Day -2 to -1, Day 1, Day 14, Day 28 (End of Treatment), Day 35 (Follow-up)
Target Sample Size	Total Sample Size="120" Sample Size from India="120"
Phase of Trial	Phase 3
Date of First Enrollment (India)	08/06/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Nil
Brief Summary	This is a randomized, double-blind, parallel-group, placebo-controlled, multi-centric clinical trial comparing the efficacy and safety of Astha-15 (polyherbal capsule) and placebo on subjects suspected and/or diagnosed with COVID-19. Two capsules twice a day for 28 days will be taken orally. Follow-up will be done 7 days after the End treatment visit (EOT) visit. The primary outcomes will be measured by St. George Respiratory Questionnaire and Leicester Cough Questionnaire from baseline to EOT. The secondary outcomes will be measured by Quality of Life (QOL) Questionnaire from baseline to EOT and evaluating rate of subjects of both groups not attaining ICU rather gaining potential to get recovered during the treatment.