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CTRI Number  CTRI/2022/09/045980 [Registered on: 28/09/2022] Trial Registered Prospectively
Last Modified On: 04/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of dietary supplementation of Flax Seeds on signs and symptoms associated with Perimenopausal Syndrome  
Scientific Title of Study   Efficacy of dietary intervention of Flaxseeds(Linum usitatissimum) on signs and symptoms associated with Perimenopausal Syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashmi Shrivastava 
Designation  PhD Scholar, Department of Physiology, King Georges Medical University, Lucknow 
Affiliation  King George Medical University, Lucknow 
Address  Rashmi Shrivastava PhD Scholar Department of Physiology King George Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7355491417  
Fax    
Email  rashmishrivastava417@kgmcindia.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Narsingh Verma 
Designation  Professor and Head, Department of Physiology, King Georges Medical University, Lucknow 
Affiliation  King George Medical University, Lucknow 
Address  Dr Narsingh Verma Professor and Head Department of Physiology King George Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9839064560  
Fax    
Email  narsinghverma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Shrivastava 
Designation  PhD Scholar, Department of Physiology, King Georges Medical University, Lucknow 
Affiliation  King George Medical University, Lucknow 
Address  Rashmi Shrivastava PhD Scholar Department of Physiology King George Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7355491417  
Fax    
Email  rashmishrivastava417@kgmcindia.edu  
 
Source of Monetary or Material Support  
Ceyon Health Care India Private Limited Lucknow Pin-226016, Uttar Pradesh, India 
 
Primary Sponsor  
Name  Indian Society of Chronomedicine 
Address  Department of Physiology King George Medical University Lucknow, Uttar Pradesh 
Type of Sponsor  Other [Research Society] 
 
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 
Rashmi Shrivastava  Queen Marys Hospital, King Georges Medical University, Lucknow  Department of Obstetrics and Gynecology, S1, Subhash Marg, Raja Bazar, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 7355491417

rashmishrivastava417@kgmcindia.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, King Georges Medical University, Lucknow, Uttar Pradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Flaxseeds 10gm OD for 3 months   Treatment group will be given 10gm ground flaxseed powder daily up to 3 months  
Comparator Agent  Roasted Wheat Flour 10gm OD for 3 months  Placebo group will be given 10gm roasted wheat flour daily up to 3 months 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1)Subjects according to the guidelines of Indian
Menopause Society, FSH level should be >20 IU/ml with Vasomotor symptoms even in the absence of cessation of menstruation
2)Age should be between 40 to 55 years
3)Not under medication (estrogen and phytoestrogen)
 
 
ExclusionCriteria 
Details  1) Surgical menopause, hysterectomy, abnormal anatomical structures of the uterus or ovaries
2) Use of HRT, SSRIs (selective serotonin reuptake inhibitors)
3) History of malignancy, mental disorders including depression), thyroid diseases
4) With heart, liver or kidney diseases
5) Use of sedative or anti-anxiety drugs, Cigarette smoking, alcohol or drug abuse
6)Participation in other clinical trials  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Significant Changes in menopausal symptom score according to
Modified Kuppermans Index Score greater than 6
Menopause Rating Scale greater than 4
MENQOL Intervention questionnaire score assessment

 		 Significant changes in menopausal symptom score
Modified Kuppermans Index Score at Baseline,12 weeks
Menopause Rating Scale at baseline, 12 weeks
MENQOL Intervention questionnaire score at baseline, 12 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Levels of lignans and hormones before and after dietary intervention
Enterolactone (ENL)
Enterodiol (END)
Estradiol hormone 		 Enterolactone (ENL) timepoint- at baseline, 12 weeks
Enterodiol (END) Timepoint- at baseline, 12 weeks
Estradiol hormone Timepoint- at baseline, 12 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 2/ Phase 3 
Date of First Enrollment (India)   20/10/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomized single-blind placebo controlled trial, to assess the effect of dietary intervention of flaxseeds(10gm) in comparison with placebo(roasted wheat flour-10gm) daily, on sign and symptoms associated with Perimenopausal Syndrome for 3 months in 120 patients(Treatment group-60 and Placebo group-60). Patients will be recruited from OPD of Queen Mary’s, Department of Obstetrics and Gynecology, King George’s Medical University and near by areas. Primary Outcome measured will be significant changes in menopausal symptoms score by Modified Kupperman’s Index Score, Menopause Rating Scale and MENQOL Intervention Questionnaire score after 3 months. Secondary outcome measured will be the levels of lignans Enterolactone(ENL) and Enterodiol(END) and Estradiol hormone after 3 months. 
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