| CTRI Number |
CTRI/2023/01/049316 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check the effect of Menoveda Akira tablet in patients having menopause related mental health issues |
|
Scientific Title of Study
|
A double blind, randomized, placebo controlled Clinical Study to Evaluate the efficacy of Menoveda Akira tablet in patients having menopause related mental health issues. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/20/113 version 1.0 Dated:23July2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha sharma |
| Designation |
Principal Investigator |
| Affiliation |
Shree Ram Hospital |
| Address |
Dept of Gynocology, Room 6, Ground Floor, Shreeram Hospital, NH-58,Partapur,Bye-Pass,Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH
250103
India |
| Phone |
7217245093 |
| Fax |
|
| Email |
Shikhasharmamgcts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
Mittal Global Clinical Trial Services |
| Address |
Dept of Clinical Research, First Floor, MGCTS Building, Mansarovar Ind Estate, Panchli Khurd, Baghpat Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937045757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
Mittal Global Clinical Trial Services |
| Address |
Dept of Clinical Research, First Floor, MGCTS Building, Mansarovar Ind Estate, Panchli Khurd, Baghpat Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937045757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Mittal Ayurved Sansthan, Sant Vihar, T.P. Nagar, Meerut, India |
|
|
Primary Sponsor
|
| Name |
Menoveda Lifesciences Pvt Ltd |
| Address |
248, SECTOR 29 GAUTAM BUDH NAGAR NOIDA, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shikha Sharma |
Shree Ram Hospital |
Dept of Gynocology, Room-6, Ground Floor, Shreeram Hospital,NH-58, Delhi-haridwar highway, Partapur Byepass rd, Meerut Meerut UTTAR PRADESH
Meerut
Meerut
UTTAR PRADESH |
7906672912
Shikhasharmamgcts@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRAMCH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F068||Other specified mental disorders due to known physiological condition. Ayurveda Condition: RAJIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Menoveda Akira Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Tablets | Placebo tablets with no active herbs |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Females from 45 to 70 years of age, post Menopause.
2.Females suffering from one or multiple mental health issues from- anxiety, insomnia, depression etc;
3.Females that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
4.Females willing to avoid participation in any other interventional clinical trial for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
2.Females that have participated in any other interventional clinical trial in the previous 30 days.
3.Females with known sensitivity to any of the constituents of the investigational product.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in SGA(Subject Global Assessment) |
Baseline Day0 - Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in MENQOL(Menopause-Specific Quality of Life questionnaire) Score |
Baseline Day0-Day30 |
| Change in QOL (DASS-21) |
Baseline Day0-Day30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/02/2023 |
| Date of Study Completion (India) |
01/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Menopause is the time that marks the end of your menstrual cycles. It’s diagnosed after you’ve gone 12 months without a menstrual period. Menopause can happen in your 40s or 50s, but the average age is 51 in the United States. Menopause is a natural biological process. But the physical symptoms, such as hot flashes, and emotional symptoms of menopause may disrupt your sleep, lower your energy or affect emotional health. There are many effective treatments available, from lifestyle adjustments to hormone therapy. This study will be done on 60 subjects for 30 days to evaluate the efficacy of Menoveda Akira Tablets. |