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CTRI Number  CTRI/2021/05/033767 [Registered on: 24/05/2021] Trial Registered Prospectively
Last Modified On: 08/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Swamala consumption on improving immune functions and Quality of life in healthy human volunteers 
Scientific Title of Study
Modification(s)  		 Prospective, Open label, Parallel Arm, Single center Exploratory study to assess effect of Swamala consumption on improving immune functions and Quality of life in healthy human volunteers 
Trial Acronym  Swamala Compound for improving immune functions and QoL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinay Pawar 
Designation  Associate Professor 
Affiliation  School of Ayurveda, D. Y. Patil University, Sector 7 
Address  Dept of Basic Principles, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai
1/3, Ganesh Kripa Sadan, Meghwadi, Jogeshwari (East), Mumbai - 400 060
Mumbai
MAHARASHTRA
400706
India 
Phone  07506631982  
Fax    
Email  vinay.pawar@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Vinay Pawar 
Designation  Associate Professor 
Affiliation  School of Ayurveda, D. Y. Patil University, Sector 7 
Address  Dept of Basic Principles, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai
1/3, Ganesh Kripa Sadan, Meghwadi, Jogeshwari (East), Mumbai - 400 060
Mumbai
MAHARASHTRA
400706
India 
Phone  07506631982  
Fax    
Email  vinay.pawar@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh Kumar Harit 
Designation  Dean and Professor 
Affiliation  School of Ayurveda, D. Y. Patil University, Sector 7 
Address  Dept of Basic Principles, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai
Dept of Basic Principles, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  09322217607  
Fax    
Email  maheshkumar.harit@dypatil.edu  
 
Source of Monetary or Material Support  
Shree Dhootapapeshwar Limited 135 Nanubhai Desai Road Khetwadi Mumbai 400004  
 
Primary Sponsor  
Name  Shree Dhootapapeshwar Limited  
Address  135 Nanubhai Desai Road Khetwadi Mumbai 400004  
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 Vinay Pawar  D. Y. Patil Ayurvedic Hospital , Special OPD  D. Y. Patil Ayurvedic Hospital - Special OPD for CLinical Trials - D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai
Thane
MAHARASHTRA 		 7506631982

vinay.pawar@dypatil.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IEC, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai  Approved 
Institutional Ethics Committee School of Ayurveda D. Y. Patil Deemed to be University, Navi Mumbai   Approved 
Institutional Ethics Committee School of Ayurveda D. Y. Patil Deemed to be University, Navi Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers (vaccinated for COVID-19)  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Swamala Compound  10 gm Swamala Compound twice a day for three months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy adult volunteers aged 18- 60 years
Voluntarily participating in the study; fully understanding and being fully informed of the study and has signed written Informed Consent Form (ICF).
Free of obvious health problems as established by medical history of past 3 months& clinical examination before entering into the study.
No evidence of any acute severe infection or moderate to high grade Fever (Axillary Temp.>99OF)
Not being COVID-19 positive within past 15 days at the time of screening.
Having taken 2 doses of Covishield / 2 doses of Covaxin Covid-19 vaccine
 
 
ExclusionCriteria 
Details  1. Refusal to participation expressed by patient.
2. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
3. Past 3 months history of or any complaints suggestive of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, rheumatological, urogenital or hematological disease.
4. Presence of any Covid related symptoms like fever, cough, breathlessness, diarrhea etc.
5. Severe hepatic or renal impairment. (Presence of values which are out of acceptable limits for LFT and/or RFT)
6. Diagnosed of Diabetes Mellitus type –II.
7. Uncontrolled Hypertension (>160/110 mmHg)
8. Presence of acute gastrointestinal symptoms at the time of screening (e.g., nausea, vomiting, diarrhea, heart burn)
9. Presence of values which are out of acceptable limits for hematological parameters(CBC).
10. Administration of immunoglobulin (including Tocilizumab for Covid-19 infection treatment )or any blood products in last 3 months
11. Vaccination within past 6 months, other than Covid-19 vaccine.
12. Pregnant or lactating women.
13. Women of child bearing age group not following contraceptive measures.
14. Participants who have participated in any clinical trial within 30 days prior to enrolment and/or intending to participate in any other clinical study during the period of this study.
15. Any other Chyawanprash or ayurvedic drug as immunoadjuvant, consumption concomitantly.
16. History of hypersensitivity to any drug, allergic disease or reactions likely to be exacerbated by any component of the Chyawanprash.
17. Confirmed immunosuppression or immunological disorders.
18. History of corticosteroid or other immunosuppressive drugs taken in the past 3 months.
19. Presence of HIV 1 or 2, Hepatitis B or C infection or venereal infection, as per history and medical records.
20. Currently undergoing anti-TB treatment.
21. Abnormal chemical and microscopic examination of urine.
22. Clinically abnormal ECG (12 lead), QTc >440 msec
23. Presence of significant infection or known inflammatory process, indicated by raised CRP.
24. History of drug dependence or habitual alcohol abuse.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
change in levels of immune markers and Improvement in Quality of life  Day 1 Day 45 Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Difference in number of episodes of general illness (fever, cough, cold) and their severity, duration of illness, between both arms.
2. Difference in rate of COVID-19 infection acquired during study duration and levels of Covid antibodies between participants in both arms.
3. Difference in no. of absent days from work due to illness, between both arms.
4. safety of the investigational product.
 		 Day 1 Day 45 Day 90 
 
Target Sample Size
Modification(s)  		 Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   01/06/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The present clinical study is planned to show immunogenicity of Swamala, in clinical trial settings.
The primary objective of the study is to evaluate immunogenicity in terms of improvement in immune markers and improvement in Quality of life after consuming Swamala daily for the study duration of 90 days.
Healthy volunteers (fully vaccinated for COVID-19) will be screened and if found eligible, they will be enrolled in the study and randomized into 2 groups in ratio of 2:1 (20 participants in in Swamala Group and 10 in Control Group = Total 30 participants). 
One group (S) will be put on Swamala 10 gm twice daily, and the other group (C) will not be consuming the investigational product. 
Participants will be followed-up 6-weekly during the treatment period of 90 days, and telephonic reminders and enquiries will be done every 7 days to ensure compliance, enquire about any episodes of general illness or COVID-19 & absent days from work due to illness/es, and collect safety data, in terms of any adverse effects experienced by the participants. 
Compliance of at least 80% will be required for the participant to complete the study.
Appropriate statistical tests will be applied to data generated through clinical trial to reach to conclusion.

 
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