| CTRI Number |
CTRI/2022/09/045996 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Observational study to assess relation between Body constitution and severity of Menopausal Syndrome w.s.r. to Kuppermans Index. |
|
Scientific Title of Study
|
An Observational Study to assess the relation between Deha Prakriti and Severity of Rajonivrutti Janya Lakshana (Menopausal Syndrome) w.s.r. to Kuppermans Index. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Rani |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra, Haryanal |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
09053394881 |
| Fax |
|
| Email |
pb88519@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Khurana |
| Designation |
Principal and Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra, Haryana |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9416337325 |
| Fax |
|
| Email |
dr.devendrakhurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Rani |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra, Haryana |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
09053394881 |
| Fax |
|
| Email |
pb88519@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Government Ayurvedic College and Hospital |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra Haryana |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, Haryana |
| Type of Sponsor |
Government 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 Devendra Khurana |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra |
Room No.- 96, PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, Haryana
Kurukshetra
HARYANA |
09416337325
dr.devendrakhurana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, (2) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Psychological Menopause
History of Hypothyroidism
History of Fibroid |
|
| ExclusionCriteria |
| Details |
Patient below 45 years of age
History of Diabetes Mellitus
History of Drug Intake
History of Carcinoma
Surgical Menopause Patients
Pregnant and Lactating women
History of Tuberculosis
Patient with severe Hormonal Imbalance |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the severity of Rajonivrutti Janya Lakshana with the help Kuppermans Index.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Prakriti of patient with the help of validated Prakriti Performa. |
Baseline |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prakriti is an important concept of Ayurveda that explain individuality. It express unique trait of an individual that is defined by specific and permanent composition of dosha right from birth. By evaluating prakriti of patient suffering from same disease we can assess the course and outcome of treatment. Ayurvedic Literature has noticed Menopause as natural process in life of women as Rajonivrutti. Menopause means permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity. Though menopause is a natural phenomemon and is a part of natural process of ageing in women and every women faces varied changes during this phase of life resulting from hormonal derangement. Such disturbances attain the stage of disease or syndrome called Menopausal Syndrome. Severity of menopausal syndrome can be measured by Kupperman’s Index. Present study is undertaken with a purpose to assess the severity of Rajonivrutti Janya Lakshana(Menopausal Syndrome) with the help of Kupperman’s Index and to find which prakriti patients are having severe symptoms of Menopausal Syndrome. |