CTRI Number	CTRI/2022/09/045585 [Registered on: 16/09/2022] Trial Registered Prospectively
Last Modified On:	26/09/2023
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Drug
Study Design	Single Arm Study
Public Title of Study Modification(s)	A study to evaluate the efficacy and safety of vestige spirulina capsules for the immunity in healthy patients.
Scientific Title of Study Modification(s)	A prospective, multicenter, open label clinical trial to evaluate efficacy and safety of Vestige Spirulina capsules in overall immunity of Healthy subjects.
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Devesh Kumar  Address  C-120,3rd Floor, Noida Sector -02, Gautam Buddha Nagar UTTAR PRADESH 201301 India  Phone  7827758840    Fax     Email  devesh.kumar@innovate-research.com
Details Contact Person Scientific Query	Name  Dr Devesh Kumar  Address  C-120,3rd Floor, Noida Sector -02, Gautam Buddha Nagar UTTAR PRADESH 201301 India  Phone  7827758840    Fax     Email  devesh.kumar@innovate-research.com
Details Contact Person Public Query	Name  Dr Devesh Kumar  Address  C-120,3rd Floor, Noida Sector -02, Gautam Buddha Nagar UTTAR PRADESH 201301 India  Phone  7827758840    Fax     Email  devesh.kumar@innovate-research.com
Source of Monetary or Material Support	Vestige Marketing Pvt Ltd.
Primary Sponsor	Name  Vestige Marketing Pvt Ltd   Address  A-89, Okhla Industrial Area Phase II New Delhi 110020   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   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Harsh Mittal   Panchsheel Hospital Pvt. Ltd.  Department of medicine, OPD room basement, Panchsheel Hospital, C-3/C-4A 64 A Opp. Gokulpuri Police Station, Yamuna Vihar North East   9560506410 harshmittal86@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee Panchsheel Hospital  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  overall immunity of Healthy subjects
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Vestige Spirulina Capsule   One Capsule to be taken 2 times a day orally after meals for 56 days
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  65.00 Year(s) Gender  Both  Details  1. Subject is willing and able to give written informed consent. 2. Aged 18-65 years of age 3. Healthy Men and non-pregnant women 4. Subject is willing, able, and likely to comply with all study procedures and restrictions.
ExclusionCriteria	Details  1. Current or 12 months prior to screening severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg, pulmonary embolism or deep vein thrombosis. 2. Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c > 10.5 %, fasting plasma glucose >270 mg/dl at screening or episodes of severe hypoglycemia 1 month prior to screening); 3. Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor. 4. Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study. 5. Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening. 6. HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history. 7. Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment). 8. Drug or alcohol abuse at the time of screening or in the past which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study. 9. Pregnant or lactating women or women planning a pregnancy during the clinical study. 10. Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient’s ability to participate in the study.
Method of Generating Random Sequence Modification(s)	Not Applicable
Method of Concealment Modification(s)	Not Applicable
Blinding/Masking Modification(s)	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  Mean change in ISQ (Immune status Questionnaire) Score from Baseline to Week 8  Day 0 to Day 56
Secondary Outcome Modification(s)	Outcome  TimePoints  • Mean change in ISQ (Immune Status Questionnaire) Score from Baseline to Week 8 • Safety and tolerability of the Vestige Spirulina Capsule will be assessed by the patient reported Clinical AEs occurring during entire duration of study.   Day 0 to Day 56
Target Sample Size	Total Sample Size="50" Sample Size from India="50"
Phase of Trial	Phase 4
Date of First Enrollment (India)	20/09/2022
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Open to Recruitment
Recruitment Status of Trial (India)	Completed
Publication Details	NIL
Brief Summary Modification(s)	Primary objective of this trial was to find out efficacy of Vestige Spirulina Capsule by evaluating Mean change in ISQ (Immune Status Questionnaire) Score from Baseline to Week 8. The ISQ questionnaire consists of 7 questions, which are used to evaluate frequency of different usual symptoms experienced by the subject due to low immunity, which is representation of overall Immunity. Mean value of Raw score of ISQ questionnaire at baseline(V1) was 1.35 which decreased to 0.54 at visit 2 (Week 4) with mean percentage change recorded as 45.71% with a statistically significant p Value(P<.0001).   Mean of Final score reported as 4.4 at baseline which increased to 8.74 at Week 8. Mean percentage of Final score is recorded as -91.26% which represents significant improvement in overall immunity of the subjects.   There are 48 subjects who reported Final score as 8 and above at Week 8 from a total of 0 subjects within this range at Baseline. A final score of 8 and above represents enhanced Immune status. A total of 11 subjects reported Final score as 10 at week 8 from 0 subjects at baseline, final score of 10 represents excellent perceived immune status.   Secondary objective of this trial was to find out safety & tolerability of Vestige Spirulina Capsule by evaluating following parameters: • Clinical Adverse events occurring during entire duration of study There were no AEs reported by the enrolled subjects during the study, which represents that Vestige Spirulina capsules are safe and tolerable for extended duration of consumption by the general population.   Conclusion: From current data set analysis of this proof-of-concept study it can be concluded that Vestige Spirulina Capsule has shown promising results in improving overall immunity. Study met its primary and secondary endpoints with significant results. Vestige Spirulina Capsule are also safe to be used as the study documented no adverse events. However, double blind, placebo-controlled studies with larger sample size and increased duration of consumption can be conducted to reproduce results like current study in consideration. Its impact on various haematological parameters can also be evaluated in future studies.