Health Condition 1: N951- Menopausal and female climactericstates
Conditions
Interventions
Intervention1: NRMN01: Two capsules daily (125 mg x 2 capsules) with water, at bedtime for duration of 56 Days.
Control Intervention1: Placebo Capsules: Two Placebo capsules daily over 56 days of dosi
Sponsors
Natural Remedies Pvt. Ltd.
InVitro Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the vasomotor subscale score of the MENQOL-I.Timepoint: From Baseline to Day 56 (End of Study). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Countries
India
Contacts
Public ContactT Vijaya Bhaskar
Invitro Research Solutions Pvt. Ltd.
Outcome results
None listed