FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/09/015614 [Registered on: 05/09/2018] Trial Registered Prospectively
Last Modified On: 03/09/2018
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 the safety and to understand the efficacy of FenuSMART on sexual functions and menstrual problems in women 
Scientific Title of Study   A randomized, double blind, placebo controlled, clinical study to evaluate the safety and efficacy of FenuSMARTâ„¢ on sexual function and menstrual problems in menstruating, perimenopausal and postmenopausal women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aman Khanna  
Designation  Principal Investigator 
Affiliation  Aman Hospital and Research Centre  
Address  Room No:1,Department of general medicine,Aman Hospital and Research Centre Pvt Ltd. 15 Shaswat opposite ESI Hospital

Vadodara
GUJARAT
390021
India 
Phone    
Fax    
Email  amankhanna11974@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Private Limited 
Address  No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Private Limited 
Address  No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar


KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Akay Flavours and Aromatics Private Limited Malaidamthuruthu P.O,Ernakulam KERALA PIN 683561 India  
 
Primary Sponsor  
Name  Akay Flavours and Aromatics Private Limited 
Address  Malaidamthuruthu P. O, Ernakulam KERALA PIN 683561 India 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
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 Aman Khanna  Aman Hospital and Research Centre   Room No: 1, Department of General medicine, 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT 		 990402122

amankhanna11974@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aman Hospital and Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  women with peri and post menopausal symptoms 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FenuSMART  250mg Two Times per day for 42 days 
Intervention  FenuSMART  250mg, Single dose per day for 42 days 
Comparator Agent  Placebo  250mg ,Two Times per Day for 42 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1 Married, sexually active female subjects.
2 Postmenopausal women according Stages of Reproductive Aging Workshop (STRAW) Classification with -no menstrual bleeding for the last 12 months
3 Perimenopausal Women according STRAW Classification. Both early and late perimenopause stages. Late perimenopause amenorrhoea for ≥60 days. Early perimenopause -irregular periods without skipping cycles and more than seven days difference in length of consecutive cycles
4 Healthy menstruating women with regular menstrual cycles.
5 Subjects with a BMI ≤ 35 kg/m2
6 Subjects with normal fasting blood glucose level.
7 Subject understands the study procedures and provides signed informed consent to participate in the study.
8 Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
9 Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
 
 
ExclusionCriteria 
Details  1 History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs on a daily basis for any conditions
2 Patients who had previous treatment with hormonal treatment or fenugreek derived products in the previous 12 months.
3 Androgen therapy within 3 months of recruitment.
4 Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.
5 Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
6 History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years
7 Subjects with abnormal ECG, biochemical or haematological values
8 Subjects, who are smokers or tobacco user
9 Pregnant and breast feeding female.
10 History of hypersensitivity reactions attributed to a convectional formulation of FenuSMARTâ„¢ or its components or related products.
11 A positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and /or syphilis.
12 Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
13 Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids and morphine)
14 History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
15 Active or history (last 6 months) of drug or alcohol abuse.
16 Participated in a clinical study with an investigational drug or biologic within the last 30 days.
17 Any condition that in opinion of the Investigator, does not justify the subjects’ participation in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
•Changes in Biochemical, Hormonal and Molecular Markers   Day 0, Day 42 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Questionnaire based assessment scores  Day 0,Day14, Day 28, Day 42 
Safety assessment and incidence of adverse Events  Day 0, Day 42 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   N/A 
Date of First Enrollment (India)   06/09/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a randomized , double blind, placebo controlled, parellel group,multicenter study. The main prurpose of this study is to prove the efficacy of FenuSMARTâ„¢  on sexual function and menstrual problems in menstruating,perimenopausal, postmenopausal women. Female subjects meeting all inclusion criteria and no exclusion criteria will sign a written informed consent and will be enrolled in the study.The study consists of seven groups, post-menopausal- treated and placebo, perimenopausal - treated and placebo and regular menstruating women - treated and placebo. The efficacy and safety of FenuSMARTâ„¢ will be established by in comparison with baseline values. The study will also evaluate effect of FenuSMARTâ„¢ on hormonal markers and its effect on safety parameters. 

 
Close