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CTRI Number  CTRI/2021/08/035970 [Registered on: 26/08/2021] Trial Registered Prospectively
Last Modified On: 12/08/2021
Post Graduate Thesis  Yes 
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 Flunil ACP Capsule for treatment of Respiratory Tract Infection  
Scientific Title of Study   Evaluation of efficacy and safety of Flunil ACP Capsules for the management of Upper Respiratory Tract Infections: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SBS/AWPL/FN/072011 Version No 1.0 Date: 30th October 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran N 
Designation  Consultant Pulmonologist 
Affiliation  Rajalakshmi Hospital 
Address  Department of Respiratory Medicine, Rajalakshmi Hospital, Bengaluru

Bangalore
KARNATAKA
560097
India 
Phone  9164673490  
Fax    
Email  balaji.kiran.n@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr C M Reddy 
Designation  Chief Scientific Officer 
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  04048593559  
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 Kiran N  Rajalakshmi Hospital,  Department of Respiratory Medicine, Rajalakshmi Hospital, Bengaluru
Bangalore
KARNATAKA 		 9164673490

balaji.kiran.n@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: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FLUNIL ACP Capsules  The investigational product, Flunil ACP Capsules is a nutraceutical product, formulated as a capsule which has Ashwagandha Extract, Liposomal Curcumin, Honeybee Propolis extract, Black Pepper Extract as main ingredients which help in boosting immunity in adults.One capsule of study treatment is to be administered orally twice a day for 30 Days. 
Comparator Agent  Placebo Capsules  The placebo capsules are similar to the FLUNIL ACP Capsules except they do not contain Active Ingredients. One capsule of study treatment is to be administered orally twice a day for 30 days. 
 
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 upper respiratory tract infections similar to flu.
3. 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 
Serum Immunoglobulins (IgG, IgM and IgA) levels documented in the CRF at baseline, and day 30  baseline, and day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Total leucocyte count (TLC), absolute lymphocyte count (ALC) and lymphocyte percentage documented in the CRF at baseline, and day 30  baseline, and day 30 
Inflammatory markers (CRP and ESR) documented in the CRF at baseline, and day 30  baseline, and day 30 
Improvement in upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30  baseline, day 15 and day 30 
Severity of upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30  baseline, day 15 and day 30 
Duration of upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30  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)   27/08/2021 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   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   The Influenza is a contagious respiratory illness, simply known as flu, is an infectious disease of the upper respiratory tract (URT) caused by various viruses include influenza virus, rhinoviruses, and corona viruses. It is characterized by symptoms like coughing or sneezing, sore throat, stuffy or runny nose, headache, fever and muscle aches or aching limbs etc. Because of similar symptoms, there is no way of distinguishing among various types of common cold, influenza and other URT infections. The global incidence rate of influenza is estimated at 5% -10% in adults and 20%–30% in children. These annual epidemics are estimated to result in about 3 to 5 million cases of severe illness and about 250,000 to 500,000 deaths globally. Influenza is a viral infection, affecting mainly the nose, throat, and bronchi. Most infected individuals do not require medical treatment and recover within one to two weeks. However, infection can lead to severe complications of underlying conditions, including pneumonia and death, especially in children, the elderly, pregnant women and those with other serious medical conditions.
More than 90% of influenza-related deaths occur in patients in the older age group. Underlying medical conditions that increase the risk of hospitalization include diabetes and cardiovascular, neurological and chronic respiratory diseases, such as asthma. The standard methods for the diagnosis of influenza include virus isolation in past years and molecular detection using real-time polymerase chain reaction assays (RT-PCR) more recently. In comparison, commercially available rapid influenza diagnostic tests (RIDT) have the advantage of providing results much more quickly (within 10-15 minutes). RIDTs work by detecting the parts of the virus (antigens) that stimulate an immune response. Influenza is highly contagious, with serious systemic symptoms and mild respiratory symptoms; its peak prevalence is in winter and spring; there are also global outbreaks and epidemics periodically.
Despite rapid developments in science and medical technology, the common cold continues to pose a tremendous burden on human health or on economic losses worldwide. Because of no effective therapies, majority of the healthcare practitioners providing treatment based on the relief of symptoms, including cough, sneezing,headache, fever, sore throat, and nasal congestion. Since there is no effective medication or vaccine for respiratory viral infections, seeking for alternative therapies is a reasonable option. A healthy immune system is one of the most important weapons for various severe medical conditions. There are numerous vitamins and trace elements which are crucial for the normal functioning of the immune system. Furthermore, supplementation of these have shown positive effect on enhancing immunity in viral infections. Supplementation of vitamin A, D and has increased humeral immunity of paediatric patients after an influenza vaccination. Additionally, several herbals, probiotics and micronutrients also have shown potency for treatment and prevention of viral 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 nutraceutical product Flunil ACP on immune boosting for management of flu like symptoms. 
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