| CTRI Number |
CTRI/2024/04/065847 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yashtimadhu churna in Post Menopausal Syndrome |
|
Scientific Title of Study
|
Effect of Yashtimadhu churna in Post Menopausal Syndrome - A Randomized Double Blind Controlled Clinical Trial |
| 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 Shweta Basapure |
| Designation |
PG Scholar Department of Rasayana Evam Vajikarana |
| Affiliation |
KAHERS Shri B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre |
| Address |
Department of Rasayana Evam Vajikarana KAHERS Shri
B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre Shahapur Belagavi Karnataka
Belgaum KARNATAKA 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
8123300451 |
| Fax |
|
| Email |
shwetabasapure1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashavva Hiremath |
| Designation |
Associate Professor Department of Kayachiktsa |
| Affiliation |
KAHERS Shri B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre |
| Address |
Department of Rasayana Evam Vajikarana KAHERS Shri
B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre Shahapur Belagavi Karnataka
Belgaum KARNATAKA 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
9448945687 |
| Fax |
|
| Email |
drkvhiremath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashavva Hiremath |
| Designation |
Associate Professor Department of Kayachiktsa |
| Affiliation |
KAHERS Shri B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre |
| Address |
Department of Rasayana Evam Vajikarana KAHERS Shri
B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre Shahapur Belagavi Karnataka
Belgaum KARNATAKA 590003 India
KARNATAKA
590003
India |
| Phone |
9448945687 |
| Fax |
|
| Email |
drkvhiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA AND RESEARCH CENTRE Shahapur
Belagavi Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Basapure |
| Address |
Department of Rasayana Evam Vajikarana KAHERS Shri
B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre Shahapur Belagavi Karnataka 590003 India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Shweta Basapure |
KAHERS Shri B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre Shahapur Belagavi |
OPD no 21 and 23 of
KAHERS Shri
B.M.Kankanwadi
Ayurveda
Mahavidyalaya
Hospital, Shahapur
Belagavi
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
8123300451
shwetabasapure1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanwadi Ayurved Mahavidyala KLE Ayurved Hospital Shahpur Belagavi |
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. Ayurveda Condition: RAJONASAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Churna, Reference: Dravya Guna vijnana Dr JLN Shastry volume 2 p152, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Churna, Reference: Dravya Guna vijnana Dr JLN Shastry volume 2 p375, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Cessation of menstruation for 12 consecutive months before enrolment into the study
Women with menopausal rating score more than 5 |
|
| ExclusionCriteria |
| Details |
Women with uncontrolled medical conditions hypertension heart diseases diabetes mellitus etc
Surgical Menopause |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in the symptoms of post menopausal syndrome like vasomotor symptoms,psychological symptoms
|
Baseline on 0th day ,2nd week and 6th week of
the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum estrogen level may be reduced after the intervention. |
Objective parameters will be assessed on
baseline on 0th day and 6th week of
the intervention. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="6"
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
|
A randomized,double blind control clinical , parallel group, single center triall comparing efficacy of Yashtimadhu churna 3gms twice a day with milk and Ashwagandha churna 3gms twice a day with milk daily for 45 days in 30 patients with Post Menopausal Syndrome will be conducted in KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA AND
RESEARCH CENTRE Shahapur Belagavi Karnataka. The primary outcome will be Yashtimadhu churna may help in relieving the symptoms of post menopausal syndrome and help in improving the QOL. |