CTRI/2021/01/030733 [Registered on: 25/01/2021] Trial Registered Prospectively
Last Modified On:
15/06/2021
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
(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)= "0" Final Enrollment numbers achieved (India)="0"
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