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CTRI Number  CTRI/2022/12/047943 [Registered on: 07/12/2022] Trial Registered Prospectively
Last Modified On: 19/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of herbal composition (LN20189) in improving immune function in healthy subjects 
Scientific Title of Study   A randomized, double-blind, placebo-controlled clinical study to evaluate the effect of LN20189 on Immune function in healthy subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LN/IF/LN20189/22 Version 01, Dated 23-Jul-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Prason Kumar J 
Designation  Overall Trial Coordinator 
Affiliation  Laila Nutraceuticals 
Address  40-15-14,First Floor,R&D Division,Clinical Research Department,Brindavan colony, Labbipet,Vijayawada

Krishna
ANDHRA PRADESH
520010
India 
Phone  08662464445  
Fax  08662475278  
Email  prason@lailanutra.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Golakoti Trimurtulu 
Designation  Senior Vice-president-Technical 
Affiliation  Laila Nutraceuticals 
Address  Ground Floor, R&D Division, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanur,Vijayawada

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666  
Fax  08662546216  
Email  drgt@lailanutra.in  
 
Details of Contact Person
Public Query  
Name  Mr Prason Kumar J 
Designation  Manager-Clinical Research 
Affiliation  Laila Nutraceuticals 
Address  40-15-14,First Floor,R&D Division,Clinical Research Department,Brindavan colony, Labbipet,Vijayawada

Krishna
ANDHRA PRADESH
520010
India 
Phone  08662464445  
Fax  08662475278  
Email  prason@lailanutra.in  
 
Source of Monetary or Material Support  
Laila Nutraceuticals Internal funding, 40-15-14, Brindavan colony, Labbipet, Vijayawada, Krishna, Andhra Pradesh- 520010 
 
Primary Sponsor  
Name  Laila Nutraceuticals 
Address  40-15-14, Brindavan Colony, Labbipet, Vijayawada, Krishna, Andhra Pradesh-520010,India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T Jayaprakash  Anu Hospitals  Kovelamudivari Street, Suryaraopet, Vijayawada-520002 Krishna, India
Krishna
ANDHRA PRADESH 		 91-7893062708

drctresearch@gmail.com 
Dr Manju Bhargavi M  Dr Bhargavis Diabetes Centre  D.No.60-9-10, Gev Radha Madhav, Old Polyclinic Road, Above Lalitha Jewellery, Siddhartha Nagar, Vijayawada - 520010. Andhra Pradesh, India
Krishna
ANDHRA PRADESH 		 9948024196

drbhargavicr@gmail.com 
Dr Karthik Naidu KC  Latha Super Specialities Hospital  29-14-58, Besides SBI Zonal Office, Prakasam Road, Suryaraopet, Vijayawada - 520002, India.
Krishna
ANDHRA PRADESH 		 91-9886605025

dr.karthik.2k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee- Anu Hospitals for Dr T Jayaprakash  Approved 
Institutional Ethics Committee- Latha Super Specialities Hospital for Dr Karthik Naidu KC  Approved 
Institutional Ethics Committee- Sri Gayathri Super Speciality Hospital for Dr Manju Bharghavi M  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Immune function 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LN20189, 250 mg  One capsule to be taken daily in the morning after breakfast for 84 days 
Intervention  LN20189, 500 mg  One capsule to be taken daily in the morning after breakfast for 84 days 
Comparator Agent  Placebo  One capsule to be taken daily in the morning after breakfast for 84 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Male and female subjects aged between 30-60 years with body mass index (BMI) of 22-29.9 kg per meter square.
2.Healthy subjects with reduced perceived Immune status (as assessed by Immune status questionnaire (ISQ) score of<6).
3.Subject agrees to maintain diet and activity levels.
4.Subject considered generally healthy as per health history and routine clinical investigations during screening.
5.Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit.
6.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent. 
 
ExclusionCriteria 
Details  1.Subjects with history or condition that caused nasal obstruction such as nasal polyps, nasal/sinus surgery and other nasal structural problems.
2.Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
3.Subjects who are taking medication for diabetes or hypertension; Subjects with FBS>125mg/dL or Systolic BP>145 or Diastolic BP>90 mmHg.
4.Subjects using Immune modifying medications (Anti-inflammatory agents, antibiotics, anti-histamines, etc. for last one month, Steroids- for last 03 months).
5.Subjects who are zinc deficient or on special diets, probiotics, taking nutritional supplements or medications known to affect immune function or absorption of nutrients.
6.Subjects with any history of immune system disorder or auto-immune disorder including but not limited to the following : AIDS, Ankylosing Spondylitis, Chronic Fatigue Syndrome, CREST Syndrome, Crohn’s Disease, Dermatomyositis, Fibromyalgia, Grave’s Disease, Hashimoto’s Thyroiditis, Lupus, Myasthenia Gravis, Pernicious Anemia, Polyarteritis Nodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaud’s Disease, Rheumatoid Arthritis, Sarcoidosis, Scleroderma, Sjogren’s Syndrome, Temporal Arthritis, Guillain-Barré Syndrome, Inflammatory Bowel Disease, Ulcerative Colitis, and Vitiligo.
7.Any health drinks, vitamin supplements or immune boosters (within 4 weeks) or nasal device/sprays deemed likely to interfere with the evaluation (e.g., other herbal or Nutraceutical products).
8.Subjects who used immunosuppressive drugs in the last 6 months.
9.Subjects with COPD, asthma, any respiratory or breathing related disorders.
10.Subjects who consume alcohol (>5 drinks per week), habit of smoking (>3 Cigarettes per day), chewing tobacco, or use of recreational drugs (such as cocaine, methamphetamine, marijuana etc.).
11.Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, and malignancies.
12.Female subjects, who are pregnant, lactating or planning to become pregnant during the study.
13.Subjects with history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
14.Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
15.Subjects with known allergy or intolerance to any of study ingredients.
16.Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening. 
 
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 
Change from baseline to the end of the study period in:
Daily completion of Wisconsin Upper Respiratory Symptom Survey (WURSS-24)
 		 Day 1, Day 21, Day 42 and Day 84
 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to the end of the study period in:
Psychological General Wellbeing Index (PGWBI)
 		 Day 1, Day 21, Day 42 and Day 84 
Change from baseline to the end of the study period in:
Immune cell population (T cells, CD4 T cells, CD8 T cells, B cells and NK cells)
 		 Day 1 and Day 84 
Change from baseline to the end of the study period in:
Total WBC count and Differential count
 		 Day 1, Day 21, Day 42 and Day 84 
Change from baseline to the end of the study period in:
Serum biomarkers (IFN-gamma, IL-4, IgG and TAC)
 		 Day 1 and Day 84 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2022 
Date of Study Completion (India) 18/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The purpose of this study is to assess the efficacy of LN20189 on immune function in healthy subjects. A total of 120 male and female subjects of age between 30 and 60 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either one of the three study groups (LN20189 250 mg or LN20189 500 mg or Placebo) at 1:1:1 ratio. The participants will be instructed to take one capsule daily in the morning after breakfast for 84 days. The outcome measures include Daily completion of Wisconsin upper respiratory symptom survey (WURSS-24), Psychological general wellbeing index (PGWBI), Immune cell population (T cells, CD4 T cells, CD8 T cells, B cells and NK cells), Total WBC count, differential count and serum biomarkers(IFN-gamma, IL-4, IgG and TAC). Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of LN20189 will also include the routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
 
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