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CTRI Number  CTRI/2020/10/028775 [Registered on: 29/10/2020] Trial Registered Prospectively
Last Modified On: 29/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate Immunity Booster Capules for boosting immunity  
Scientific Title of Study   Evaluation of efficacy and safety of Immunity Booster Capsules as an Immunity Booster in Adults: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AWPL-IMC-IBA  Other 
SBS/AWPL/IMC/07209 Version 1.0 Date: 29th July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Giriraja KV 
Designation  Consultant Physician 
Affiliation  Rajalakshmi Hospital 
Address  Department of General Medicine, Rajalakshmi Hospital, Lakshmipura Main Road, Vidyaranyapura Post, Bangalore

Bangalore
KARNATAKA
560097
India 
Phone  9738877298  
Fax    
Email  drgirirajkv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr C M Reddy 
Designation  Chief Scientific Offer 
Affiliation  Amitojas Wellness Private Limited 
Address  #3-100-55/739, Block-A,2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad

Hyderabad
TELANGANA
500014
India 
Phone  8885324455  
Fax    
Email  cso@amitojas.com  
 
Details of Contact Person
Public Query
 
Name  Mr Kamal Kammili 
Designation  Director - Operations 
Affiliation  Sanjeevani Bio Services Private Limited 
Address  3rd Floor, Plot No. 28B, Raghavendra Colony, Kondapur, Hyderabad

Hyderabad
TELANGANA
500084
India 
Phone    
Fax    
Email  kamal.kammili@sanjeevanibio.com  
 
Source of Monetary or Material Support  
Amitojas Wellness Private Limited 
 
Primary Sponsor  
Name  Amitojas Wellness Private Limited 
Address  2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad, Telangana – 500014, India 
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 Giriraja KV  Rajalakshmi Hospital  Department of General Medicine, Lakshmipura main road, Vidyaranyapura post, Bangalore
Bangalore
KARNATAKA 
9738877298

drgirirajkv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D849||Immunodeficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Immunity Booster Capsules  Immunity Booster Capsules is a nutraceutical product, formulated as a capsule which has Shitake mushroom extract (30% Polysachharides- AHCC), Vitamin D3 (Chole calciferol), Vitamin C (L-Ascorbic acid), Vitamin E (mixed tocopherols), Vitamin B6 (pyridoxine Hcl), Zinc (as zinc sulphate) and Beta Carotene. One capsule of study treatment is to be administered orally twice a day. 
Comparator Agent  Placebo Capsules  The placebo capsules are similar to the Immunity Booster Capsules excpet they do not contain Active Ingredients. One capsule of study treatment is to be administered orally twice a day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and female subjects aged 18 years and above.
2. Subjects with general immunodeficiency as determined by the study investigator.
3. Subjects who are prone to seasonal immunity associated illnesses as determined by the study investigator
4. Subjects willing to provide informed written consent. 
 
ExclusionCriteria 
Details  1. Pregnant, planning to become pregnant or breastfeeding women.
2. Subjects with significant medical/surgical condition which requires long-term treatment.
3. Subjects who are currently being treated with other immunostimulant drugs.
4. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
5. Alcohol or substance abuse
6. Allergy or sensitivity to any of the ingredients in the study treatment
7. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
8. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Total leucocyte count (TLC), absolute lymphocyte count (ALC) and lymphocyte percentage documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Serum immunoglobulins (IgM, IgG and IgA) and natural killer cells levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
Episodes of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons).  baseline, day 15 and day 30 
Severity of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)  baseline, day 15 and day 30 
Duration of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)  baseline, day 15 and day 30 
Number of subjects having immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)  baseline, day 15 and day 30 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   30/10/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Bacterial and Viral infections affect all ages and are the leading cause of morbidity and mortality across the world. Viruses are probably the most common cause of infectious disease acquired within indoor environments and both virus and bacteria have considerable impact on human health, ranging from severe life-threatening illnesses to relatively mild and self-limiting or asymptomatic diseases. This may depend on the immune status of the patient and their ability to clear infection as well as the characteristics of the pathogen. Increasing numbers of people who have reduced immunity to infection, where the consequences of infection can be much more serious than healthy individuals. In general, bacteria and viruses causing respiratory and gastrointestinal diseases spread rapidly in the community and cause considerable morbidity.
Despite the advances in medical and science technology, there are few conventional medications or vaccines for most of the infection causing bacteria and viruses. However, the microorganisms gaining resistance to the existing drugs which is making the treatment difficult. Because of this, most of the researchers are focusing on nutritional supplements for natural immune boosting. A healthy immune system prevents the incidence of various infectious diseases. There are numerous vitamins and trace elements which are essential for normal functioning of the immune system. Additionally, several herbals, probiotics and micronutrients also have shown potency for treatment and prevention of infections. Moreover, several nutraceuticals and probiotics have also shown a complementary role in enhancing immune responses. Therefore, the purpose of study is to investigate the effect of nutraceuticals as an immune booster for maintaining a healthy immune system in adult population.
 
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