| CTRI Number |
CTRI/2024/09/074367 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Earthful Women 40 plus Supplement in Menopause
Symptom Management and Quality of Life improvement in Menopause Women. |
|
Scientific Title of Study
|
To Evaluate the Efficacy and Safety of Earthful Women 40 plus Supplement in Menopause
Symptom Management and Quality of Life improvement in Perimenopause and
Postmenopausal (Menopause) Women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjana Kumari Vt |
| Designation |
Principal Investigator |
| Affiliation |
Sri Lakshmi Hospital |
| Address |
50 opp Velankani Road Doddathogur village electronic city phase 1 Bengaluru
Bangalore
KARNATAKA
560100
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
drsanjanalaxmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvind Patnaik |
| Designation |
Associate director Project Operations |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Syncorp Health Pvt Ltd
Building 06 3rd & 4th floor 2nd Main Road Sarvobhogam Nagar Arekere Bengaluru Karnataka India
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Patnaik |
| Designation |
Associate director Project Operations |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Syncorp Health Pvt Ltd
Building 06 3rd & 4th floor 2nd Main Road Sarvobhogam Nagar Arekere Bengaluru Karnataka India
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Sri Lakshmi Hospital
#50, opp. Velankani road,
Doddathogur village, Electronic city,
Phase 1, Bengaluru 560100
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Kenzen Ventures Private Limited |
| Address |
10-3-311/4A, Road no. 2, Castle Hills
Vijaynagar Colony, Near NMDC,
Masab Tank Road Hyderabad - 500057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjana Kumari Vt |
Sri Lakshmi Hospital |
Gyanecology Department, OBG division, 4th Floor, No.50, opp. Velankani road,
Doddathogur village, Electronic city,
Phase 1, Bengaluru 560100
Bangalore
KARNATAKA |
9538601116
drsanjanalaxmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Earthful Women Multivitamin 40+ |
Product Name - Earthful Women Multivitamin 40+
Consumption pattern/Frequency -consume 2 Capsules immediately after breakfast,
lunch or dinner for 90 days
Food category - Foodstuffs intended for particular nutritional uses
Sub-food Category - Health Supplements
Route of adminstration - Oral
Dose - 150 ml in soft gelatin capsule
Total duration-90 days |
| Comparator Agent |
Placebo |
Product Name - Placebo pattern/Frequency -consume 2 Capsules immediately after breakfast, lunch or dinner for 90 days
Food category - Placebo
Sub-food Category - Placebo Route of adminstration - Oral Dose - 150 ml in soft gelatin capsule
Total duration-90 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Perimenopausal women and postmenopausal women in the age group of 40 to 65
years.
2. Participants who are apparently healthy.
3. Women who have at least 5 points of MRS score.
4. Calcium deficiency Biomarkers |
|
| ExclusionCriteria |
| Details |
1. Perimenopausal women and postmenopausal women in the age group of 40 to 65
years.
2. Participants who are apparently healthy.
3. Women who have at least 5 points of MRS score.
4. Calcium deficiency Biomarkers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in global scores of Menopausal Rating Scale (MRS). .The MRS Scale Measures the following parameters: (11 points - hot
flashes, mood swings , anxiety, fatigue ,Body pains,sleep disturbances, vaginal
dryness)
2. Calcium Biomarkers
|
1. (Day 0, Day30, Day
60 & Day 90)
2.Day 0 & Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in the frequency and severity of hot flushes
2. Change in the frequency and severity of night sweats.
3. Change in the frequency and severity of sleep disturbances.
4. Change in Fatigue assessment scale.( Hot Flushes, Heart discomfort, sleeping
problems, depressive mood, irritability, Anxiety, physical and mental exhaustion,
Sexual Problems, Bladder Problems, Dryness of Vagina, joint, Calcium
Biomarkers and muscular discomfort)
5. Patient acceptance and satisfaction as analysed by Menopause Symptoms Treatment
Satisfaction Questionnaire (MS-TSQ) Questionnaire.
6. The Menopause Specific Quality of Life Questionnaire-MENQOL |
1. Day 0, Day30, Day 60 & Day 90
2. Day 0, Day30, Day 60 & Day 90
3. Day 0, Day30, Day 60 & Day 90
4. Day 0, Day30, Day 60 & Day 90
5. Day 0, Day30, Day 60 & Day 90
6. Day 0, Day30, Day 60 & Day 90 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/09/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Menopausal symptoms severely reduce the quality of life of post-menopausal women worldwide. Nutraceuticals are widely prescribed as a viable and safer alternative and complementary approach to standard therapies. The aim of this study was to evaluate the clinical efficacy and safety of a nutraceutical in post-menopausal women. |