FULL DETAILS (Read-only)

CTRI Number  CTRI/2020/06/025590 [Registered on: 03/06/2020] Trial Registered Prospectively
Last Modified On: 23/06/2020
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  
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 chronic bronchitis and/or emphysema, 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)  Open to Recruitment 
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.

 

Close