CTRI Number	CTRI/2020/06/025855 [Registered on: 13/06/2020] Trial Registered Prospectively
Last Modified On:	26/12/2024
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug Ayurveda
Study Design	Randomized, Parallel Group Trial
Public Title of Study	Effect of AYUSH 64 in COVID 19
Scientific Title of Study	Efficacy of Ayurveda Intervention (AYUSH 64) as add-on therapy in COVID 19 patients - An open label randomized controlled trial
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Prof Anup Thakar  Address  Director office IPGT and RA Gujarat Ayurved University Jamnagar Jamnagar GUJARAT 361008 India  Phone  9427776660   Fax     Email  directoripgt@ayurveduniversity.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Mandip Goyal  Address  Room no 403 Kayachikitsa department IPGT and RA Gujarat Ayurved University Jamnagar agar Jamnagar GUJARAT 361008 India  Phone  9427572306   Fax     Email  kaurmandip22@yahoo.com
Details Contact Person Public Query Modification(s)	Name  Dr Sagar M Bhinde  Address  Room no 533 kaumarbhritya department IPGT and RA Gujarat Ayurved University Jamnagar Jamnagar GUJARAT 361008 India  Phone  9662512158   Fax     Email  sgrbhinde@gmail.com
Source of Monetary or Material Support Modification(s)	IPGTRA Gujarat Ayurved University Jamnagar
Primary Sponsor	Name  IPGT and RA   Address  Director office IPGT and RA Gujarat Ayurved University Jamnagar Gujarat India   Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 2   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Anup Thakar  IPGT and RA Hospital Jamnagar  2nd floor IPD ward Jamnagar   9427776660 directoripgt@ayurveduniversity.com  Dr Yagnik Chotala  Guru govind singh government hospital Jamnagar   COVID ward Department of Medicine Jamnagar   9925564861 cyagnik27@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 3   Name of Committee  Approval Status  IEC MP SHAH GOVERNMENT MEDICAL COLLEGE  Approved  IEC MP SHAH GOVERNMENT MEDICAL COLLEGE  Approved  IEC MP Shah Government Medical College  Not Applicable
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent	Type  Name  Details  Intervention  AYUSH 64   AYUSH 64 02 Capsules of 500mg each orally thrice daily for 14 days as add-on therapy to supportive and symptomatic allopathic treatment for COVID 19 patients  Comparator Agent  Control arm  Supportive or symptomatic allopathic treatment as per guideline of study site hospital for COVID 19 patients
Inclusion Criteria	Age From  18.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  Asymptomatic or minimal symptomatic COVID 19 patients Patients having 0 to 4 score as per the WHO ordinal scale for clinical improvement Age 18 to 70years Patients who can take oral medicine Patients who are ready to give written consent
ExclusionCriteria	Details  Age below 18 and above 70years Patients having severe symptoms of COVID19 Patients on mechanical ventilator or organ support Patients do not able to take oral medication Pregnant and lactating women Oncological diseases and other systemic uncontrol conditions such as HTN diabetes etc Liver or kidney malfunctions. Severe pneumonia Acute respiratory distress syndrome Sepsis and Septic Shock
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Ordinal scale for Clinical improvement as per WHO Duration on mechanical ventilator All cause mortality   0 7 14 and 28th day
Secondary Outcome	Outcome  TimePoints  Number of patients developed symptoms   0 14 and 28th day  Number of patients who needed oxygen therapy   0 14 and 28th day  Number of patients who needed mechanical ventilator   0 14 and 28th day  Total duration of symptomatic phase  0 14 and 28th day  Duration on oxygen therapy  0 7 14 and 28th day  Number of cases reporting any ADR AE   0 7 14 and 28th day
Target Sample Size	Total Sample Size="200" Sample Size from India="200"
Phase of Trial	Phase 2
Date of First Enrollment (India)	15/06/2020
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)	25. Anup Thakar, Mandip Goyal, Sagar Bhinde, Yagnik Chhotala, Kalpesh Panara, Swapnil Chaudhari, Impact of AYUSH 64 as an adjunctive to standard of care in mild COVID 19 - An open-label randomized controlled pilot study. Journal of Ayurveda and Integrative Medicine, Volume 13, Issue 3, 2022, 100587, ISSN 0975-9476
Brief Summary Modification(s)	Background: Ayurveda herbal formulation AYUSH-64, proven to treat malaria and influenza-like illness in India was repurposed for COVID-19 patients considering preliminary evidences, however, scientific data was not available. Aim: To evaluate the preliminary efficacy and safety of AYUSH 64 as an add-on to standard of care in mild COVID19 patients. Materials and methods: A single center, randomized, open-labeled, controlled, pilot study were conducted on mild COVID 19 confirmed patients. Patients allotted in interventional group (n ¼ 41) received AYUSH 64, 3 gm per day in three divided dose for 14 days as an adjuvant to standard of care (SOC) whereas control group received SOC (n ¼ 39) alone. Outcomes were reduction in WHO ordinal scale for clinical improvement, all-cause mortality, incidence of COVID19 symptoms among asymptomatic patients at baseline, use for oxygen therapy, use for a mechanical ventilator, the total duration of symptomatic phase and adverse events. Results: Mean score of WHO ordinal scale was reduced as time lapse in both the groups (f (1) ¼ 20.5, p < 0.001) indicating clinical improvement among groups. There was no statistically significant difference in mean WHO ordinal scale between groups (f (1) ¼ 0.98, p ¼ 0.32). The proportion of asymptomatic patients progressing to the symptomatic stage is lower in AYUSH 64 group [OR, 0.68 (CI, 0.17 e2.66)]. Mean days for the total duration of the symptomatic phase was also short in AYUSH 64 group (4.68 ± 3.29 days) compared to SOC group (5.81 ± 3.5 days). No incidence of the requirement of a mechanical ventilator, adverse drug reaction and death were observed in either of the groups. Conclusion: The findings of this pilot study show that an integrated approach of AYUSH 64 with SOC provide early trends of benefit by reduction in disease progression and in total symptom duration. However, its effects remains inconclusive on outcomes such as all cause mortality, use of oxygen therapy, invasive ventilator due to sparse outcomes.