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CTRI Number  CTRI/2021/09/036826 [Registered on: 24/09/2021] Trial Registered Prospectively
Last Modified On: 07/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on the efficacy of Tulasi-Ashwagandhadi Herbal Drops on Oxygen Saturation (SPO2) in the management of COVID-19 affected cases. 
Scientific Title of Study   A double blinded randomized controlled clinical study to evaluate the efficacy of the Tulasi Ashwagandhadi Herbal Drops on Oxygen Saturation (SPO2) in the management of COVID-19 affected cases. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh T S 
Designation  Professor and HOD 
Affiliation  Prasanna College of Ayurveda 
Address  Department of Dravyaguna Prasanna College of Ayurveda and Hospital Ujire Belthangady Road Laila Belthangady

Dakshina Kannada
KARNATAKA
574214
India 
Phone  9448160784  
Fax    
Email  dtsmv2002@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sowmya Saraswati M 
Designation  Professor and HOD 
Affiliation  Alvas Ayurveda Medical College 
Address  Department of PG Studies in Ayurveda Samhita and Siddhanta Alvas Ayurveda Medical College Moodbdiri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9448006199  
Fax    
Email  directoratmarc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geetha M B 
Designation  Professor 
Affiliation  Alvas Ayurveda Medical College 
Address  Department of PG Studies in Roga Nidana Alvas Ayurveda Medical College Moodbdiri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9901859343  
Fax    
Email  drgeetamk@gmail.com  
 
Source of Monetary or Material Support  
Material support - Alvas Ayurveda Medical College & Hospital Vidyagiri Moodbidri - 574227 
Monetary Support - Charak Hanf Private Limited T-10 803 Vipul Garden Kalinga Nagar Ghatikia Bhubaneshwar – 7510003 ORISSA 
 
Primary Sponsor  
Name  Charak Hanf Pvt Ltd 
Address  T-10, 803 Vipul Garden, Kalinga Nagar, Ghatikia Bhubaneshwar – 7510003 ORISSA 
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 Mahesh T S  Alvas Ayurveda Medical College and Hospital  Vidayagiri Moodbidri-574227
Dakshina Kannada
KARNATAKA 		 9448160784

dtsmv2002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethics Committee  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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Tulasi-Ashwagandhadi Herbal Drops, Reference: NA, Route: Oral, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 20(drops), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male or female subjects who have been found to be COVID-19 positive
The Oxygen Concentration level (SpO2) is between 85-95% observable during baseline screening.
Subjects in the age group 18-65 years (both the ages inclusive).
Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
Subjects with mild to moderate level of symptoms pertaining to COVID-19
Subjects willing to abide by and comply with the study protocol.
Subjects who have not participated in a similar investigation in the past three months. 
 
ExclusionCriteria 
Details  Subjects who have undergone invasive treatments like surgery or other treatment within 3 months before screening into the study.
Subjects having any active disease which may interfere in the study.
Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
Subjects (females) who are pregnant or lactating
A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products.
Chronic illness which may influence the respiratory state.
Subjects who had been part of any other clinical study within 3 months before screening into the study. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Test product in elevation of SpO2 Concentration over Treatment Phase and Followup Phase in comparison to Baseline  Baseline, Day1, Day4, Day7, Day14 and Day21 
 
Secondary Outcome  
Outcome  TimePoints 
To study the efficacy of Test product in SpO2 Conc elevation after Day1 Day4 and Day7 of treatment in comparison to baseline
Day1 vs baseline
Day7 vs Day4
Day4 Vs Day1
Day7 vs baseline
Day14 vs baseline
Day14 vs Day7
Day21 vs Baseline
Day21 vs Day7
Comparison of X-Ray Hb TC ESR CRP and D-Dimmer - after regimen - week 1
Day 7 vs baseline
Comparison of Subjective criteria after regimen - week 1
Day 7 vs baseline
To evaluate the product acceptance and tolerance 		 Baseline, Day1 (After day1 of treatment), Day4 (Mid-term of treatment), Day7 (After Treatment), Day14 and Day21 (After followup period) 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 
Date of First Enrollment (India)   11/10/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Suspended 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Covid-19 is a pandemic health challenge that has affected millions of people around the world today. The present health setup is trying its level best to control and improve the condition in this regard. Its symptoms range from Mild to Severe which is at times even life threatening. The product is an Ayurvedic formulation where the combination of the herbs that are basically used in many Ayurvedic formulaitons that have been found to be useful in the management of symptoms namely Kasa (Cough), Shwasa (Dyspnea), Jwara (Hyperpyrexia), Shotha (Inflammation) etc. These symptoms are found in the mild cases of Covid-19 pandemic too especially in the mild cases.   

Hence, the current study is planned to evaluate the safety and efficacy of the product in mild to moderate cases of Covid-19 affected to male and female subjects as an adjuvant to the general existing treatment protocol.

 
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