| 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
|
|
|
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
|
|
|
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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