| CTRI Number |
CTRI/2025/08/093681 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| 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 FenuSmart in Improving Premenstrual Syndrome, Dysmenorrhea and Sexual Function in Young and Perimenopausal Women |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of FenuSmart in Improving Premenstrual Syndrome, Dysmenorrhea and Sexual Function in Young and Perimenopausal Women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-AK-170, Version No. 01 dated 23 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saumya D S |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
OPD No.5, Ground Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8792516793 |
| Fax |
|
| Email |
drsaumyads.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Researchand Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, 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 |
Managing Director and CEO |
| Affiliation |
Leads Clinical Researchand Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd. Malaidamthuruthu P. O Ernakulam, Cochin 683561 Kerala, India |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt. Ltd |
| Address |
Malaidamthuruthu P. O Ernakulam, Cochin 683561 Kerala, India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumya D S |
BGS Global Institute of Medical Sciences |
OPD No.05,Ground Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
8792516793
drsaumyads.research@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N94||Pain and other conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FenuSmart |
Oral administration of single dose of FenuSmart once a day to the end of three menstrual cycles |
| Comparator Agent |
Placebo |
Oral administration of single dose of Placebo once a day to the end of three menstrual cycles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects with regular menstrual cycles 2.Subjects who are able to reliably recall and report PMS symptoms and menstrual pain intensity from at least two of the last three menstrual cycles 3.Subjects with a documented history of mild to moderate PMS and or dysmenorrhea, assessed by PSST score 4.Subjects with a BMI between 18.5 to 29.9 kg per meter square 5.Subjects willing to refrain from taking any medications or supplements during the study 6.Subjects who agree to maintain their usual dietary habits and level of exercise 7.Subjects willing to refrain from taking any medications or preparations to improve PMS during the study 8.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days 9.Subjects must be willing and able to provide informed consent and comply with the study procedures 10.Subjects must be able to understand and adhere to the study requirements, including consuming the investigational product, attending all scheduled visits, and following study guidelines 11.Females of childbearing age, agree to use approved birth control methods during the study, and have negative UPT at screening 12.A visual analog scale score greater or equal to 4 in young women 13.A visual analog scale score greater or equal to 4 for dysmenorrhea in Perimenopause women 14.Subjects with MRS score 0-4, indicating minimal menopausal symptom burden and eligibility for PMS assessment 15.Perimenopausal symptoms: vasomotor symptoms, psychological symptoms , or genitourinary symptoms in Perimenopause women
|
|
| ExclusionCriteria |
| Details |
1.Subjects who use hormonal contraceptives or other hormonal therapies 2.Subjects experiencing oligomenorrhea or irregular menstrual cycle 3.Subjects unable to read and understand the informed consent and study materials 4.Subjects with a history of drug dependence, high alcohol intake , or the use of recreational drugs , or nicotine or caffeine dependence
5.Subjects with chronic medical conditions or medication use that may interfere with study outcomes 6.Subjects with psychiatric diagnoses including generalised anxiety or depression 7.Subjects taking multivitamins, herbal supplements, or other wellness products 8.Subjects suffering from a metabolic disorder and or from severe chronic disease or from a disease found to be inconsistent with the conduct of the study by the investigator 9.Subjects with moderate to severe fatigue or having chronic fatigue syndrome 10.Subjects with a malignant disease or any concomitant end-state organ disease and or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 11.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications 12.Subjects with uncontrolled hypertension at screening 13.Subjects who have been involved in a clinical study within the past 30 days 14.Subjects with hypersensitivity or a history of allergy to the study product 15.Any other conditions that, in the investigator’s opinion, would warrant exclusion or prevent the participant from completing the study 16.Subjects with a history of drug and or alcohol abuse at the time of enrolment 17.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period 18.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry 19.Any additional condition that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing 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 |
Mean change in PMS severity and Dysmenorrhea
|
Baseline, Cycle 1, Cycle 2, Cycle 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in Sexual function |
Baseline, Cycle 1, Cycle 2, Cycle 3 |
| Mean change in energy and fatigue |
Baseline, Cycle 1, Cycle 2, Cycle 3 |
| Mean change in quality of life |
Baseline, Cycle 1, Cycle 2, Cycle 3 |
| Mean change in skin parameters |
Baseline, Cycle 1, Cycle 2, Cycle 3 |
| Mean change in biomarker levels |
Baseline, Cycle 1, Cycle 2, Cycle 3 |
| Safety of FenuSmart |
Baseline, Cycle 1, Cycle 2, Cycle 3 |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double-blind, placebo-controlled,
parallel group, clinical interventional study. In order to evaluate the effect
of the investigational product (IP) on the study objectives, the study will
focus on two age groups: Young women aged 18-39 years and women in the
peri-menopause phase aged 40-55 years with 70 subjects in each group. Overall, 140 adult healthy females, meeting
all inclusion and no exclusion criteria will be enrolled in the study after
signing a written informed consent. After the informed consent process,
demographic details such as date of birth, ethnicity and race will be obtained.
Medical history including hypertension, diabetes mellitus, chronic liver,
gastrointestinal and renal disorders, surgeries, any other clinically
significant medical and medication history will be obtained. Subjects found
eligible for study participation will be randomized into one of the treatment
arms (1:1) as per randomization schedule for a treatment period of three
consecutive menstrual cycles.
The study consists of four phases over four
menstrual cycles, involving six clinical visits and two telephonic assessments.The subjects will be
dispensed with the test product as per randomization and will be instructed to consume
the IP for three consecutive menstrual cycles, 30 minutes after meal.
A subject diary shall be provided to the
subjects to record the study product administration, AEs, and concomitant
medications details during the study duration. |