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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  
Not Applicable  
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Parul University Limda Vadodaa Gujarat 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
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  
Status 
Not Applicable 
 
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).

 
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