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CTRI Number  CTRI/2024/09/074433 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
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 Efficacy of 300 mg and 500 mg Doses of Fenavari on Menopause Symptoms. 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate the Safety and Efficacy of 300 mg and 500 mg Doses of Fenavari on Menopause Symptoms. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-OA-144, Version 1.0 dated 24 August 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidya V Bhat 
Designation  Medical Director 
Affiliation  Radhakrishna Multispeciality Hospital 
Address  OPD 1, Department of OBG,Ground Floor, 3-4 Sunrise Towers, Girinagar

Bangalore
KARNATAKA
560085
India 
Phone  8792516793  
Fax    
Email  drvidyavbhat.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, No.9, 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  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, No.9, Mythri Legacy, Chelekere Main Road, Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
OmniActive Health Technologies, T8A, Wing A, Phoenix House, 462, Senapati Bapat Marg, Lower Parel, Mumbai 400013  
 
Primary Sponsor  
Name  OmniActive Health Technologies 
Address  T8A, Wing A, Phoenix House, 462, Senapati Bapat Marg, Lower Parel, Mumbai 400013 
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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roopa N K  BGS Global Institute of Medical Sciences  OPD No.4, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9741073960

drroopankct@gmail.com 
Dr Tushar K Suvagiya  Jupiter Hospital and Research Centre  OPD 1, Opp. ICAI Bhavan, Sunpharma - Atladara Road,
Vadodara
GUJARAT 		 9482164779

drtusharks.ct@gmail.com 
Dr Vidya V Bhat  Radhakrishna Multispeciality Hospital and IVF Center  Room No.01, Ground Floor, 3-4, Sunrise Tower, J.P Road, Girinagar
Bangalore
KARNATAKA 		 8792516793

drvidyavbhat.research@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Jupiter Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N951||Menopausal and female climactericstates,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fenavari 300 mg  Oral administration of two 150 mg capsules for 84 days 
Intervention  Fenavari 500 mg  Oral administration of two 250 mg capsules for 84 days 
Comparator Agent  Placebo  Oral administration of two capsules for 84 days 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Subjects with menopause symptoms, defined as a score of greater or equal to 12 to lesser than equal to 32 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women)
2. Subjects who experience hot flashes and/or night sweats at least once per day
3. Subjects who experience at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes
4. Subjects with BMI between 18 and 40 kg/m at the time of screening
5. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period
6. Subjects willing to refrain from taking any medications or preparations for addressing menopause symptoms, stress or anxiety or mood or sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study
7. Subjects willing to refrain from consuming alcohol 24 hours prior to the test days
8. Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to test days
9. Subjects willing to refrain from vigorous physical activity 12 hours prior to test days
10.Subjects willing to provide written consent
11. Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study 
 
ExclusionCriteria 
Details  1.Subjects having hypersensitivity or history of allergy to the study product
2.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
3.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator
4.Subjects with a psychiatric diagnosis including anxiety or depression
5.Subjects with sleep disturbances and/or are taking sleep aid medication
6.Subjects with history of using hormonal therapy for menopause
7.Subjects with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening
8.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications
9.Subjects who have excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater or qual to 3 cups of caffeinated coffee/day) throughout the study period
10.Subjects with a history of drug and /or alcohol abuse at the time of enrolment
11.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry 
 
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 of menopause symptoms as assessed by MRS  Baseline, Day 14, Day 28, Day 56 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in Anxiety  Baseline, Day 14, Day 28, Day 56 and Day 84 
Mean change in Mood  Baseline, Day 14, Day 28, Day 56 and Day 84 
Mean change in Sleep Quality  Baseline, Day 14, Day 28, Day 56 and Day 84 
Mean change in the following Biomarkers:
- Serum Estradiol
- Progesterone
- Follicle-Stimulating Hormone (FSH) 		 Baseline,Day 56 and Day 84 
Overall Safety  Baseline, Day 14, Day 28, Day 56 and Day 84 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   07/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 prospective, double blind, randomized, placebo controlled, three-arms, parallel group study. After the informed consent process,the subject will be evaluated for symptoms, medical history and medications. The subjects fulfilling the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. Subjects shall be randomly assigned in 1:1:1 ratio to one of the three treatment groups. Clinical assessments shall include all the measures required for the primary and secondary objectives of the study. The safety assessments shall include monitoring of adverse events (AEs), physical examination, vital signs measurement, Urine Pregnancy Tests (UPT; for females of childbearing potential), hematology and clinical chemistry and urine routine tests. 
 
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