CTRI Number |
CTRI/2019/10/021722 [Registered on: 18/10/2019] Trial Registered Prospectively |
Last Modified On: |
16/10/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A clinical study to evaluate the effciency of indigenous Avaleha formulation in the management of Rajonivrutti lakshnas w.s.r to post menopausal syndrome. |
Scientific Title of Study
|
A clinical study to evaluate the efficacy of indigenous Avaleha formulation in the management of Rajonivrutti lakshnas w.s.r to post menopausal syndrome. |
Trial Acronym |
Rajonivrutti Lakshana Menopause |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Minakshi singh |
Designation |
Post Graduation (M S) |
Affiliation |
Parul Institue of Ayurveda |
Address |
Dr L P Sundhashu
AT ARNIA
PO JANDAHA
DIST VAISHALI
BIHAR
Parul Institute of ayurveda
Parul University
limda
vadodara Vadodara GUJARAT 844505 India |
Phone |
9608398775 |
Fax |
02668260201 |
Email |
minakshisingh943@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rita makim |
Designation |
Professor |
Affiliation |
Parul Institue of Ayurveda |
Address |
Parul Institute of ayurveda
Parul University
limda
vadodara Parul Institute of ayurveda
Parul University
limda
vadodara Vadodara GUJARAT 391760 India |
Phone |
9427538404 |
Fax |
02668260201 |
Email |
ritamakim@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rita makim |
Designation |
Professor |
Affiliation |
Parul Institue of Ayurveda |
Address |
Parul Institute of ayurveda
Parul University
limda
vadodara Parul Institute of ayurveda
Parul University
limda
vadodara Vadodara GUJARAT 391760 India |
Phone |
9427538404 |
Fax |
02668260201 |
Email |
ritamakim@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Parul Institute of Ayurved |
Address |
Parul University
Limda Vadodaa Gujarat |
Type of Sponsor |
Research institution and hospital |
|
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 |
Minakshi singh |
Parul Ayurveda Hospital and Khmedas Ayurveda Hospital and Parul Sevashram Hospital |
department of prasuti tantra and stree roga parul ayurveda hospital parul university limda vadodara Vadodara GUJARAT |
9608398775 02668260201 minakshisingh943@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: N951||Menopausal and female climactericstates, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Avaleha in Post Menopausal women |
Dose 24gms twice daily before food with milk 1 month
follow up 1 month |
Comparator Agent |
Not applicable |
NA |
|
Inclusion Criteria
|
Age From |
45.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Female |
Details |
Back ache
vaginal dryness
hot flushes
excessive sweating
headache
mood swings
depression
sleep disturbance |
|
ExclusionCriteria |
Details |
pre mature menopause(before 40 years)
any pre-exisiting psychological disorders
delayed menopause
diabetes mellitus
surgical menopause
disc problem
any systemic disorders |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
improvement in symptoms clinical features of post menopausal syndrome |
3 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
improvement in general health
improvement in symptoms |
after clinical trial period |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 1 |
Date of First Enrollment (India)
|
31/10/2019 |
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
|
Will be done later |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Menopause means permanent cessation of menstruation
at the end of reproductive life due to loss of ovarian follicular activity. It is the point of time when last & final
menstruation occurs. The clinical diagnosis is confirmed
following stoppage of menstruation(Amenorrhea) for twelve consecutive months
without any other pathology. Age at which menopause occurs is genetically
predetermined.The age of menopause ranges between 45-55 years, average being
50years.
According to Sushruta menstruation
starts at the age of 12 years & continuing in regular period (every month)
stops at the age of 50 when the body is fully in grip senility.
Women are affected in varying degrees by the uncomfortable symptoms that can accompany
menopause such as irregular menstrual cycles, hot flushes, disturbed sleep
patterns, vaginal discomfort, and the emotional difficulties.About 60% of
women approaching the age of menopause experience some symptoms due to
biochemical changes taking place within. Symptoms often subsides naturally as
the menopausal years progress .Other women experience symptoms suddenly or very
intensely, and seek medical relief for their debilitating effect. In the Modern medicine Hormone
Replacement Therapy(HRT) has been mentioned but there are a lot of risk
associated with HRT like Endometrial cancer,Breast cancer, venous
thromboembolic(VTE)disease,Coronary heart disease(CHD),Lipid metabolism,
DementiaAlziemer. So it is the need to
find efficient, economic, natural and safer formulation to manage post
menopausal syndrome.
In this study drugs
like Shatavari, Shankhpuspi, Jatamansi,Brahmi Sarpgandha ,Durva, Guduchi,Udumber,
Bala, Aswagandha ,Arjun, Asthi shrunkhala and Godanti are taken. These durugs
have laghu sinigdhaguna and madhur rasa and sheet virya having Balya
,Medhya,Nidrajanan and rasayan properties. With all these drugs we are
formulating avalehakalpana.AIM To
Evaluate the efficacy of Indigenous drugs on post menopausal syndrome.(Rajonivruttilakshanas) OBJECTIVES To study in detail
rajonivruttilakshanasw.s.r to post menopausal syndrome according to ayurvedic
and modern science. HYPOTHESIS:- I.
Null hypothesis: Avaleha formulation of indigenous drugs are not
effective in the management of post-menopausal syndrome.(ie. Rajonivruttilakshanas). II. Alternate hypothesis: Avaleha formulation of indigenous drugs are effective
in the management of Post-menopausal syndrome. (RajonivruttiLakshanas). |