CTRI Number	CTRI/2022/09/045314 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On:	26/09/2023
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug
Study Design	Single Arm Study
Public Title of Study	clinical trail to evaluate efficacy and safety of Vestige Noni capsules in improving Overall health of healthy population.
Scientific Title of Study Modification(s)	A prospective, multicenter, open label, clinical study to evaluate efficacy and safety of Vestige Noni capsules in improving Overall health of healthy population.
Secondary IDs if Any	Secondary ID  Registry  CT-IR-VG-NN-2022/ Version 1.0/ Date 31 May 2022  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Devesh Kumar   Address  C-120,3rd Floor, Noida Sector -02, Uttar Pradesh - 201301 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, Uttar Pradesh - 201301 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, Uttar Pradesh - 201301 UTTAR PRADESH 201301 India  Phone  7827758840   Fax     Email  devesh.kumar@innovate-research.com
Source of Monetary or Material Support	Vestige Marketing Pvt Ltd., A-89, Okhla Industrial Area Phase II New Delhi 110020
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 64A Opp. Gokulpuri Police Station, Yamuna Vihar North East   9560506410 harshmittal86@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Improving Overall health of healthy population
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  NIL  NIL  Intervention  Vestige Noni Capsule   One Capsule to be taken 2 times a day (BD) orally after meals for 30 days
Inclusion Criteria	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 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	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Mean change in Health-related quality of life- SF 36 Questionnaires   Day 0 to Day 30
Secondary Outcome	Outcome  TimePoints  •Mean Change in the Short General Health Questionnaire (GHQ 12) score •Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study.   Day 0 to Day 30
Target Sample Size	Total Sample Size="50" Sample Size from India="50"
Phase of Trial	Phase 4
Date of First Enrollment (India)	15/09/2022
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)	Not Applicable
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 Noni Capsule by evaluating mean change in Health-related quality of life- SF 36 Questionnaires from baseline to day 30. The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) and is representation of overall health. Mean value of SF 36 questionnaire at baseline(V1) was 59.0 which increased to 74.0 at visit 2 with mean percentage change recorded as 25.42% with a statistically significant p Value(P<.0001)   Secondary objective of this trial was to find out safety & tolerability of Vestige Noni Capsule by evaluating follwoing parameters: ·       Mean Change in the Short General Health Questionnaire (GHQ 12) score ·       Clinical Adverse events occurring during entire duration of study   The GHQ-12 covers several domains associated with a person’s psychological well-being and is worded in such a way as to comprise six positive and six negative items concerning the past few weeks of a person’s life.   Mean value of General Health Questionnaire (GHQ 12) at baseline(V1) was 19.1 which increased to 31.98 at visit 2 with mean percentage change recorded as 67.40% with a statistically significant p Value(P<.0001) There were 3 adverse events reported in the study which were non serious and categorised not related to study drug by the study investigator. From current data set analysis of this proof-of-concept study it can be concluded that Vestige Noni Capsule has shown promising results in improving overall health.  Study met its primary and secondary endpoints with significant results. Vestige Noni Capsule are also safe to be used as the study documented very less adverse events(n=3, 6%) which were not related to the study product. 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.