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CTRI Number  CTRI/2021/01/030733 [Registered on: 25/01/2021] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study on Zandu Chyawanprash, Zandu Pure Honey, Trishun Tablets and Immuzan Tablets as an add to treatment of Covid 19 
Scientific Title of Study   A Prospective, Randomized, Open Label, two arm, comparative clinical study to evaluate the efficacy and safety of Fixed Ayurvedic Regimen (Zandu Chyawanprash plus Zandu Pure Honey plus Trishun Tablets plus Immuzan Tablets) as an add on to Conventional treatment in the management of Mild & Moderate COVID 19 patients for period of 8 weeks 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EMA-FAR-CVD-19/2021/01 Version 1.0, Dated 3rd Jan 2021   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narendrakumar B Mundhe 
Designation  Assistant Professor 
Affiliation  KVTR Ayurvedic College Boradi 
Address  Department of Kayachikitsa, OPD No. 5, Ground Floor, KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist. Dhule

Dhule
MAHARASHTRA
425428
India 
Phone  9850378206  
Fax    
Email  drnbmundhe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Tamoli  
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research, Department of Medical Services, 4th Floor, A 402-A,B,C, Jaswanti Allied center, Ramchandra lane extn, Kachpada, Malad W, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Tamoli  
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research, Department of Medical Services, 4th Floor, A 402-A,B,C, Jaswanti Allied center, Ramchandra lane extn, Kachpada, Malad W, Mumbai


MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Emami Ltd, 687, Annadapur, EM Bypass, Kolkata-700107. 
 
Primary Sponsor  
Name  Emami Ltd 
Address  687, Annadapur, EM Bypass, Kolkata-700107. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Narendrakumar B Mundhe  KVTR Ayurvedic College and Hospital  Department of Kayachikitsa, OPD No. 5, Ground Floor, Boradi, Tal. Shirpur, Dist. Dhule-425428
Dhule
MAHARASHTRA 
9850378206

drnbmundhe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KVTR Ayurvedic College, Boradi  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. Ayurveda Condition: SANNIPATAJAJVARAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Standard care  Conventional Treatment as advised / prescribed by concerned health authorities  
Comparator Agent  Standard care  Conventional Treatment as advised / prescribed by concerned health authorities  
Intervention  Zandu Chyavanprash  Zandu Chyavanprash include Bilva, Agnimantha, Syonaka, Patala, Gambhari, Shalaprani, Prishniparni , Brihati, Kantakari, Gokshura, Bala, Mudgaparni, Mashaparni, Karkatshringi, Tamalaki, Draksha , Jivanti, Pushkara Haritaki ,Guduchi, Vidari, Musta , Rakta Punarnava, Vasa, Kakanasika, Pippali, Sukshmaila, Riddhi &Vriddh, Meda & Mahamedha, Jivaka & Rishabhak, Kakoli & Kshir kakoli. Powder of the Following: Pippali , Vanshalochana, Tvak, Tvakpatra, Sukshmaila, Nagakesara , Amalaki, Til tail, Ghrita, Guda, Honey along with preservatives and excipients Dosage and Treatment Duration: Subjects will be given Zandu Chyavanprash in a dose of 10-12 gm twice daily for 8 weeks  
Intervention  Zandu Immuzan Tablet  Contains extract of Tulasi (Ocimum sanctum Linn.) Wh. Pl., Asvagandha (Withania somnifera Dunal.) Rt., Vasa (Adhatoda vasica Nees) Lf., Sati (Hedychium spicatum Ham. ex Smith) Rz. , Guduci (Tinospora cordifolia (Willd.) Miers.) St., Haridra (Curcuma longa Linn.) Rz. , Kantakari (Solanum surattense Burm. f.) Wh.Pl., Pippali (Piper longum Linn.) Fr., Amalaki (Emblica officinalis Gaertn.) Fr. 6 gm each Dosage and Treatment Duration: Subjects will be given Zandu Immuzan Tablet in a dose of 2 tablets twice daily for 8 weeks  
Intervention  Zandu Pure Honey  Contains honey Dosage and Treatment Duration: Subjects will be given Zandu Honey in a dose of 1 tsf twice daily for 8 weeks  
Intervention  Zandu Trishun Tablet  Contains Sudarshan Churna – 600mg and Tribhuvankirtirasa – 130 mg Dosage and Treatment Duration: Subjects will be given Zandu Trishun Tablet in a dose of 1 tablet twice daily for 2 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with mild to moderate symptoms [as per US-CDC classification of COVID-19
2. Clinical presentation with Laboratory (RT-PCR or Rapid antigen or any other test for COVID19 as per current guidelines) confirmed infection of COVID-19
3. Subjects having symptoms not more than 3 days
4. Ready to provide written informed consent for participation in the study
5. Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt/ local health authority throughout the study period.
 
 
ExclusionCriteria 
Details  1. Patients with known history of Diabetes Mellitus
2. Patients having difficulty in swallowing oral medications.
3. AYUSH system-based contraindications
4. Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria
(i) Respiratory distress at room ambience (Greater than or equal to 30 breaths per min)
(ii) Oxygen saturation at rest less than or equal to 93 percent (peripheral digital oxymeter) and requiring oxygen support for over one hour to normalize
(iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure.
5. Patients who have participated in other clinical trials within last 1 month;
6. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study
7. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
8. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
9. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
10. Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study
11. Allergies, known to be allergic to Investigational Products (Ayurvedic Formulations)
12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Mean time (days) required for clinical recovery from COVID-19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms)
2. Comparative assessment of post-clinical recovery (signs, symptoms, lab parameters) over a period of 8 weeks between the two groups.
 
Screening Visit (Day -3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean time (days) required for testing negative for SARS-CoV-2
2. Change in duration of fever and other respiratory symptoms and WHO Ordinal scale
3. Changes in disease progression and requirement of Oxygen, ICU and Ventilator Support
4. Changes in percent mortality, post clinical recovery, lab parameters, rescue medication, health status on WHO QOL BREF
5. Global assessment of overall change as per the investigator and the subject
6. AE, SAE 
Screening Visit (Day -3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   01/02/2021 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet done 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   It is a prospective, randomized, open label, two arm, comparative clinical study to evaluate the efficacy and safety of Fixed Ayurvedic Regimen (Zandu Chyawanprash + Zandu Pure Honey + Trishun Tablets + Immuzan Tablets) as an add on to Conventional treatment in the management of Mild & Moderate COVID-19 patients for period of 8 weeks. The study will be carried out at 2-3 centres in India. As per computer generated randomization list, subjects will be divided in group A or group B. Subjects in group A will be given Fixed Ayurvedic Regimen (Zandu Chyawanprash- 10-12 gm twice daily for 8 weeks + Zandu Pure Honey-1 tsf twice daily for 8 weeks + Trishun Tablets - 1 tablet twice daily for 2 weeks + Immuzan Tablets – 2 tablets twice daily for 8 weeks) as an add on to Conventional medication (SOC) as advised / prescribed by concerned health authorities for 8 weeks. Subjects in group B will be advised to take Conventional medications (SOC) in the prescribed dosage as advised by the concerned health authorities for a period of 8 weeks. The primary objectives of the study will be to assess mean time (days) required for clinical recovery from COVID-19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms) and comparative assessment of post-clinical recovery (signs, symptoms, lab parameters) over a period of 8 weeks between the two groups. The secondary objectives will be to assess mean time (days) required for testing negative for SARS-CoV-2 on nasal or throat swab, change in duration of fever and other respiratory symptoms, changes on WHO Ordinal scale between the groups, changes in disease progression and requirement of Oxygen, ICU admission and Ventilator Support, changes in percent mortality, post clinical recovery, lab parameters, rescue medication,   health status on WHO QOL BREF, between the groups, global assessment of overall change as per the investigator and the subject and occurrence of AE, SAE on screening visit (day -3 to day 0),  baseline visit  (day 0), evaluation during hospitalization, day 7, discharge visit, day 14, day 28, day 42 and day 56 
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