| CTRI Number |
CTRI/2025/04/084672 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the signs and symptoms of Asthimajjakshaya (bone and marrow depletion) In menstruating and menopausal women. |
|
Scientific Title of Study
|
A case control study to assess Asthimajjakshaya Lakshanani In
menstruating and menopausal 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 |
Vd Arun Uttamrao Rathod |
| Designation |
PG Scholar Rognidana Department |
| Affiliation |
Bhartiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
| Address |
Bhartiya Sanskriti Darshan Trust Ayurved Mahavidyalaya Rognidana Department. A3 Building, 1st floor, Room No. C29
VishwashantiDham Kesnand Road Wagholi,Pune.
Pune
MAHARASHTRA
412207
India |
| Phone |
9673920543 |
| Fax |
|
| Email |
arunrathod2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Arun Kulkarni |
| Designation |
Professor and HOD of Rog Nidan Evum Vikruti Vigyan. ,Department |
| Affiliation |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
| Address |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya Rognidana Department. A3 Building, 1st floor, Room No. C29
VishwashantiDham Kesnand Road Wagholi Pune.
Pune
MAHARASHTRA
412207
India |
| Phone |
9422164367 |
| Fax |
|
| Email |
archana.arukulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Arun Kulkarni |
| Designation |
Professor and HOD of Rog Nidan Evum Vikruti Vigyan. |
| Affiliation |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
| Address |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya, Rognidana Department. A3 Building, 1st floor, Room No. C29
VishwashantiDham Kesnand Road Wagholi Pune.
Pune
MAHARASHTRA
412207
India |
| Phone |
9422164367 |
| Fax |
|
| Email |
archana.arukulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya Vishwashanti Dham Kesnand Road
Wagholi Pune. Maharashtra India.,412207 |
|
|
Primary Sponsor
|
| Name |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
| Address |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya
Vishwashanti Dham Kesnand Road Wagholi Pune.Maharashtra., India., 412207 |
| Type of Sponsor |
Private medical college |
|
|
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 Arun Uttamrao Rathod |
Bharatiya Sanskriti Darshan Trust Ayurved Hospital. |
OPD and IPD patients of Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya Vishwashanti Dham Kesnand Road Wagholi
Pune
MAHARASHTRA |
9673920543
arunrathod2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
a) Case Group- Women with physiological menopause.
b) Control Group- Regular menstruating women. |
|
| ExclusionCriteria |
| Details |
Women with irregular menstrual cycle, Malignancy , Genetic disorders, Women on dietary supplements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and document the Association between Asthimajjakshaya Lakshanani In menstruating and menopausal women |
Assessment will be done on day 0 and day 1
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe & document the Association between menstruating and menopausal women & bone minaral density |
Assessment will be done on day 0 and day 1
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/05/2025 |
| 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 present case cantrol study is to assess the relationship between asthimajjakshya lakshanani in menopausal women and also in menstruating women With the help of bone mineral density test Total 90 volunteer will be taken which will be divided into 45 in case group that is menopausal women and 45 in control group that is menstruating women with specially design case record form and bone mineral density test will perform The relationship between two would be aimed to adopt early asthimajjakshya lakshanani in menstruating women and menopausal women with the help of bone mineral density test.
Early detection of asthimajjakshya lakshanani in menstruating women as well as in menopausal women with the help of bone mineral density test would help in giving idea regarding preventive and curative aspect such as changing lifestyle and dietery pattern. |