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CTRI Number  CTRI/2025/08/093781 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study how NRMN01 capsules help with symptoms like hot flashes and mood swings in women around menopause. 
Scientific Title of Study
Modification(s)  		 A Randomized, Double Blind, Placebo Controlled study to evaluate the efficacy and safety of NRMN01 in the management of Vasomotor and mood related menopausal symptoms in Peri and Post Menopausal Women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
iVRS-CD-25-042,Version 01, Dated: 14 Aug 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narayanaswamy V 
Designation  Principal Investigator 
Affiliation  Vagus Super Specialty Hospital 
Address  Room No. 1, Ground Floor, Gynecology Department, OPD Building, Vagus Super Specialty Hospital, #6,7,8, 18th Cross, 4th Main, Malleshwaram

Bangalore
KARNATAKA
560055
India 
Phone  9448053952  
Fax    
Email  drnarayanavagus@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Channabasavanna G Halasagi 
Designation  Medical Monitor 
Affiliation  Invitro Research Solutions Pvt. Ltd. 
Address  Clinical Development Department Medical Monitoring Division Room No 302 3rd Floor, No. 22 & 23 Kodigehalli Main Road Sahakar Nagar Post, Hebbal Bangalore KARNATAKA 560092 India

Bangalore
KARNATAKA
560092
India 
Phone  6366947473  
Fax    
Email  channa@ivrs.org.in   
 
Details of Contact Person
Public Query  
Name  T Vijaya Bhaskar 
Designation  Senior Director Clinical Development 
Affiliation  Invitro Research Solutions Pvt. Ltd. 
Address  Clinical Development Department Room No. 301 3rd Floor No. 22 and 23 Kodigehalli Main Road Sahakar Nagar Post Hebbal Bangalore KARNATAKA 560092 India

Bangalore
KARNATAKA
560092
India 
Phone  6366575282  
Fax    
Email  vijay@ivrs.org.in  
 
Source of Monetary or Material Support  
Natural Remedies Pvt. Ltd. Plot No. 5B, Veerasandra Industrial Area, 19th K.M. Stone, Hosur Road Post, Electronic City Phase II, Electronic City, Bengaluru, Karnataka 560100 
 
Primary Sponsor  
Name  Natural Remedies Pvt. Ltd. 
Address  Plot No. 5B, Veerasandra Industrial Area, 19th K.M. Stone, Hosur Road Post, Electronic City Phase II, Electronic City, Bengaluru, Karnataka 560100 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
InVitro Research Pvt Ltd  No. 22 and 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal, Bangalore 560092 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Farzana Mustaq Ahmed  Santhosh Hospital  Room No. 3 3rd Floor Gynecology Department OPD Building Santhosh Hospital 6 or 1 Promenade Road Behind Coles Park Frazer Town Bangalore KARNATAKA 560005 India
Bangalore
KARNATAKA 		 9845084911

guideline9@hotmail.com 
Dr Narayanaswamy V  Vagus Super Specialty Hospital  Room No. 1, Ground Floor, Gynecology Department, OPD Building, Vagus Super Specialty Hospital, #6,7,8, 18th Cross, 4th Main, Malleshwaram, Bengaluru-560055 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9448053952

drnarayanavagus@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Santhosh Institutional Ethics Committee  Approved 
Vagus Institutional Ethics Committee  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  NRMN01  Two capsules daily (125 mg x 2 capsules) with water, at bedtime for duration of 56 Days. 
Comparator Agent  Placebo Capsules  Two Placebo capsules daily over 56 days of dosing period. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Peri and post menopausal women aged 40 to 55 years (both inclusive) with intact uterus and self reported hot flushes (at least 10 hot flushes per week for past 5 weeks).
2. Perimenopausal and postmenopausal women who are experiencing bothersome VMS (Vasomotor Symptoms). Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months.
3. Participants who score in the range of greater than or equal 12 for Vasomotor symptom domain of MENQOL I.
4. Non alcoholic.
5. No plan to commence new treatments over the study period.
6. BMI between 18 kg per m2 and 35 kg per m2 (both inclusive).
7. Not pregnant, intending pregnancy, or breast feeding during the study period.
8. Understand, willing and able to comply with all study procedures.
9. Women who are not undergoing treatment for vasomotor symptoms.
10. Participants who are agreeing to abstain from all dietary supplements.
11. Participants who can sufficiently comprehend the questionnaires and assessments of the study.
12. No other medical condition known to cause sweating and or flushing.
13. No implanted pacemakers or metal implants.
14. No reliance on electronic devices for regular monitoring (i.e insulin pumps or blood pressure monitors).
15. Results of screening procedures and lab investigations are within normal range or considered not clinically significant by the Principal Investigator. 
 
ExclusionCriteria 
Details  1. Pregnant women or lactating women, women who were actively trying to conceive, participants who had undergone hysterectomy.
2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper or hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease or gallstones or biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition, chronic gynaecological disease conditions.
3. Positive serology for HIV, hepatitis B (HBsAg), hepatitis C (anti HCV) or Syphilis at screening.
4. Diagnosis of medical or psychiatric conditions including but not limited to psychiatric disorder (other than mild to moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), cancer or malignancy.
5. Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants.
6. History of using estrogen or progestin containing products in the past 3 months
7. Oral medications causing or influencing hot flushes (Eg. clonidine, SSRI, SNRI etc.)
8. Use of hormonal contraceptives or hormonal medication for any other indication in the last 3 months.
9. Additional mineral or vitamin supplement intake.
10. Participants who are consuming or planning to consume soy or estrogenic foods like soybean oil or other estrogenic diet supplements. Specifically, consumption of soy food greater than or equal 1 portion per week.
11. Women with vasomotor symptoms due to breast cancer treatment or surgical menopause.
12. People who follow vegan diet.
13. Change in medication in the last 3 months or an expectation to change during the study duration.
14. Major lifestyle change planned in the next 2 months.
15. Current or 12 month history of illicit drug abuse.
16. A history of breast cancer in first degree family members
17. Any significant surgeries over the last year.
18. Participation in any other clinical trial a month prior to screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the vasomotor subscale score of the MENQOL-I.   From Baseline to Day 56 (End of Study).  
 
Secondary Outcome  
Outcome  TimePoints 
1.Reduction in the vasomotor subscale score of the MENQOL-I questionnaire.
2.Reduction in the mean score and subscale scores of MENQOL-I questionnaire.
3.Change in Depression, Anxiety and Stress Scale - 21 Items (DASS-21).
4.Change in Visual Analog Mood Scales (VAMS).
5.Reduction in the frequency, severity, and mean Hot Flush Score (HFS) using the Daily Hot Flush Diary. 		 1.From baseline to Day 14, Day 21, Day 28, Day 35, Day 42, and Day 49.
2.From baseline to Day 14, Day 21, Day 28 Day 35, Day 42, Day 49 and Day 56.
3.From baseline to Day 14, Day 21, Day 28 Day 35, Day 42, Day 49 and Day 56.
4.From baseline to Day 14, Day 21, Day 28 Day 35, Day 42, Day 49 and Day 56.
5.From baseline to Day 14, Day 21, Day 28 Day 35, Day 42, Day 49 and Day 56. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/09/2025 
Date of Study Completion (India) 06/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Menopausal symptoms including hot flushes mood swings sleep disturbances and vaginal dryness can significantly impair the quality of life in affected women. These symptoms may be alleviated to some extent through the administration of local or systemic exogenous estrogen via hormone replacement therapy (HRT). However the long term use of HRT is associated with an increased risk of serious complications including breast cancer cardiovascular events and thromboembolism alongside other potential side effects. Due to these risks there is a growing need for alternative safer options to manage menopausal symptoms effectively.
Although NRMN01 has proven its efficacy in the management of various diseases and disorders further clinical studies are needed to substantiate the clinical efficacy of this in the management of hot flushes and night sweats. Preclinical evidence indicates a non hormonal mechanism of action in reduction of vasomotor symptoms. This clinical trial focuses on evaluating the efficacy and safety of NRMN01 in the management of menopause related symptoms through a non hormonal mechanism. The study is conducted based on the rational that the pre clinical studies highlighted the efficacy of NRMN01 on menopause related symptoms.
 
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