| CTRI Number |
CTRI/2024/07/070216 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to check benefit of iCare plus in management of health during menopause period |
|
Scientific Title of Study
|
Clinical study to evaluate effect of iCare plus in management of health during menopause period. A quality-of-life clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRPL/IV/2023/12 Date 05 march 2024 version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hema Divakar |
| Designation |
Investigator |
| Affiliation |
Divakars Speciality Hospital |
| Address |
Divakars Speciality Hospital, 220, 9th cross, 2nd phase, J P Nagar, Department of Obstetrics and Gynecology, Room no 2.
Bangalore
KARNATAKA
560078
India |
| Phone |
9900154448 |
| Fax |
|
| Email |
divakargv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hema Divakar |
| Designation |
Investigator |
| Affiliation |
Divakars Speciality Hospital |
| Address |
Divakars Speciality Hospital, 220, 9th cross, 2nd phase, J P Nagar, Department of Obstetrics and Gynecology, Room no 2
KARNATAKA
560078
India |
| Phone |
9900154448 |
| Fax |
|
| Email |
divakargv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hema Divakar |
| Designation |
Investigator |
| Affiliation |
Divakars Speciality Hospital |
| Address |
Divakars Speciality Hospital, 220, 9th cross, 2nd phase, J P Nagar, Department of Obstetrics and Gynecology, Room no 2
KARNATAKA
560078
India |
| Phone |
9900154448 |
| Fax |
|
| Email |
divakargv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indusviva Healthsciences Pvt Ltd, Viva tower no.36, Nandi Durga Road Jayamahal Extension Bangalore, Karnataka, India 560046 |
|
|
Primary Sponsor
|
| Name |
IndusViva Healthsciences Pvt Ltd |
| Address |
Viva tower no.36, Nandi Durga Road Jayamahal Extension Bangalore, Karnataka 560046 |
| 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 Hema Divakar |
Divakars Speciality Hospital |
Department of Obstetrics and Gynecology, room no 2, Building no 220, 9th cross, 2nd phase, J P Nagar, Bangalore 560078
Bangalore
KARNATAKA |
9900154448
divakargv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Divakars Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women during Menopause stage, age between 40 to 50, no history of hysterectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
iCare plus |
Polyherbal liquid formula containing Emblica officinalis, Bosewellia serrata, Curcuma longa, Asparagus racemosus, Tribulus terrestris, Vitex negundo, Cissus quadrangularis, Centella asiatica, Valeriana wallichii , Sesamum indicum , Crocus sativus, Pyrus malus, Citrus aurantium, Syzygium cumini, Daucus carota, Prunus persica. 60ml to be taken orally, twice daily for 6 months. |
| Comparator Agent |
Placebo |
Liquid containing sweetener, permitted coloring agent, permitted flavoring agent, thickener, stabilizer and acidity regulator. 60ml to be taken orally twice daily for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged over 40
2.Subjects going through menopause
3.Subjects who voluntarily agree to participate in this clinical trial in writing
4.Subjects who have more than 2 symptoms according to menopause care QOL |
|
| ExclusionCriteria |
| Details |
1.Subjects with hysterectomy or oophorectomy
2.PCOD or similar condition
3.Subjects who are on steroids for certain health conditions
4.Subjects who refuse to sign the informed consent form.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Menopause Rating scale, hot flushes, night sweats, anxiety, stress, joint pain and other symptoms of menopause |
baseline, 3rd month and 6th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in lab values for estrogen, FSH and LH. Also, safety of IP |
baseline, 3rd month and 6th month. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="1"
Months="0"
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
|
The main objective of the trial is to
evaluate benefit of IP in Reduction in Hot flashes, Reduction in Night sweats, coping up with
anxiety & stress, Reduced Muscle & Joint pains, Feel Energetic, help
weight management, Overcoming Vaginal Dryness, FSH
& Estrogen (estradiol), Luteinizing hormone, through MENQOL and MRS QOL
questionnaire to evaluate general health and wellbeing during menopause and to
assess the safety of the iCare+. |