FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078378 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
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 ShataVida in Improving the Menopausal Symptoms in Healthy Women. 
Scientific Title of Study   A Randomized, Double Blind, Placebo Controlled, Parallel-Group Clinical Study to Evaluate the Safety and Efficacy of ShataVida in Improving the Menopausal Symptoms in Healthy Women. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-VH-148, Version 1.0 dated 12 Sep 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roopa N K  
Designation  Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Gynecology, OPD No.4, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9741073960  
Fax    
Email  drroopankct@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


KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Vidya Herbs Pvt Ltd,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India  
 
Primary Sponsor  
Name  Vidya Herbs Pvt Ltd  
Address  Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,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 Roopa N K  BGS Global Institute of Medical Sciences  Department of Gynecology, OPD No.4, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9741073960

drroopankct@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituttional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N958||Other specified menopausal and perimenopausal disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Oral administration of one 250 mg tablet for 56 days 
Intervention  ShataVida  Oral administration of one 250 mg tablet for 56 days  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.Subjects with a BMI of 18.5 to 29.9 kg/m2 2.Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening 3.Subjects with moderate or severe rating according to the modified Kupperman menopausal index severity grading 4. Subjective symptoms of hot flushes 5.Subjects willing and able to give informed consent and comply with the study procedures 6.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period 7.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 8.Subjects willing to refrain from consuming alcohol 24 hours prior to the test days 9. Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to test days 10. Subjects willing to refrain from vigorous physical activity 12 hours prior to test days 11.Subjects willing to provide written consent 12.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.Subject with a medical history of breast cancer, cervical cancer, endometrial cancer, colorectal cancer, or ovarian cancer 2.Subject with untreated or under medication of thyroid disorders 3.Subject with a history or current diagnosis of any major diseases of cardiovascular, gastrointestinal, hepatic, renal, pulmonary, or endocrine systems 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 diabetes and hypertension 8.Subject with a history or current diagnosis of autoimmune conditions 9.Subjects with HIV positive status
10. Subject with alcohol intake greater than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers 11.Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit 12.Clinically significant or abnormal laboratory results during screening 13.Any condition judged by the investigator to be unsuitable for participation in the study 14.Subjects having hypersensitivity or history of allergy to the study product 15.Subjects, who are pregnant, breast feeding or planning to become pregnant during the study period 16.Subjects leading irregular lifestyles 17.Any additional condition(s) 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 of perimenopausal and menopausal symptoms by various assessments  Screening, Day 28 and Day 56 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in serum hormone levels  Baseline, Day 56 
Overall Safety  Baseline, Day 56 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/12/2024 
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)   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 double blind, randomized, placebo controlled, 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 ratio to one of the two 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.
 
Close