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CTRI Number  CTRI/2017/12/010831 [Registered on: 11/12/2017] Trial Registered Prospectively
Last Modified On: 07/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes
Other (Specify) [Panchakarma, Life Style Modifications]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Role of Ayurveda treatment in the management of Menopause 
Scientific Title of Study   Randomized study to evaluate the role of Prakriti specific lifestyle modifications, Rasayana Churna & Shirodhara in post-menopausal women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kamini Dhiman 
Designation  Associate professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Stree Roga and Prasuti Tantra All India Institute of Ayurveda, Gautampuri Mathura Road Sarita Vihar New Delhi 110076 India

South
DELHI
110076
India 
Phone  8512813414  
Fax    
Email  kd44ayu@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kamini Dhiman 
Designation  Associate professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Stree Roga and Prasuti Tantra All India Institute of Ayurveda, Gautampuri Mathura Road Sarita Vihar New Delhi 110076 India

South
DELHI
110076
India 
Phone  8512813414  
Fax    
Email  kd44ayu@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Bushra Khanam 
Designation  PG Scholar 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA  
Address  Department of Stree Roga and Prasuti Tantra All India Institute of Ayurveda, Gautampuri Mathura Road Sarita Vihar New Delhi 110076 India

South
DELHI
110076
India 
Phone  8130220704  
Fax    
Email  bushrakhanam14@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Sarita Vihar, New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Department of Stree Roga and Prasuti Tantra All India Institute of Ayurveda Gautampuri Mathura Road Sarita Vihar New Delhi 110076 India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kamini Dhiman  All India Institute of Ayurveda  OPD No 203, Second Floor, OPD Block, Department of Stree Roga and Prasuti Tantra
South
DELHI 
8512813414

kd44ayu@yahoo.co.in 
 
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  MENOPAUSAL SYMPTOMS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rasayana Churna  3 gm of Rasayana Churna twice with luke warm water, daily after meals for 21 days will be administered. 
Intervention  Rasayana Churna and lifestyle modifications   3 gm of Rasayana Churna twice with luke warm water, daily after meals for 21 days will be administered. Prakriti specific lifestyle modifications will be advocated to the patients in this group. 
Comparator Agent  Rasayana Churna, Prakriti specific lifestyle modifications and Shirodhara  3 gm of Rasayana Churna twice with luke warm water, daily after meals for 21 days will be administered. Prakriti specific lifestyle modifications will be advocated, besides Abhyanga with Tila taila for 15 minutes, Sarwanga Swedana by Dashmool Kashaya for 5-7 minutes, Shirodhara with Bala ashwagandhadi taila diluted with equal quantity of Tila Taila 21 days schedule with 5 days Shirodhara sessions of 30 minutes with 3 days break in between will be advocated to the patients in this group.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Women fulfilling the diagnostic Criteria of menopausal syndrome
2. Post menopausal women with symptoms of menopausal syndrome, who are willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Post menopausal women who had previous exposure to therapies e.g. Yoga, and Panchkarma procedures taken within 3 months.
2. Post menopausal women who are undergoing hormonal replacement therapy.
3. Patients suffering from any major illness, e.g. Cancer, Diabetes Mellitus, Cardiac disorders, Tuberculosis etc.
4. Patients having surgical menopause 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the symptoms as per the KI  21 days  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Quality Of Life   81 days 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2018 
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="5"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The outcome will be published in leading indian journals for wider dissemination 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Menopause is one of the most important stages of life of a woman. It marks the cessation of menstruation leading to women’s aging process. In other words, it is the physiological cessation of the menstrual cycle associated with advancing age. It is a natural process that happens to every woman as she grows older and not a medical problem, disease or illness, even though it may appear so. As a result of an increase in life expectancy over the last few decades, women may live one third of their lives in post-menopause. While mentioning physiology of menstrual cycle in ayurvedic classics, it is mentioned that menstrual cycle permanently stops at the age of 50 years and also mentioned  as a kshaya state and it is a Vata stage of life as per the dominance of Doshas in reference to the phases of life .Women in a reproductive phase of life having Pitta predominance terminates into a Vata phase of life and during this phase of life of a women she has a various anatomical and psychological symptoms too and the symptoms are described as menopausal syndrome in a modern medical science.

Kshaya of raja which can be known as Rajonivritti or Menopause is attained at the age of 50 years. Ayurveda links it with ageing. Ageing is a Vata predominant stage of life.  Considering this stage as a generalized Kshaya Avastha, Rasayana therapy seems to be a treatment of choice, to nourish the Dhatus, prevents the ill effects of ageing, increase intelligence and body resistance and affects the body and mind in bringing out physical and psychological improvements.

Hormone replacement therapy (HRT) is the main treatment for the menopausal symptoms until the evidence from Women’s Health Initiative trial revealed potential risks of stroke and breast cancer in 2002. Concern regarding the adverse effects of HRT has led to demand for alternative therapies. Considering this, it has been planned to conduct a survey in different zones of Delhi, further conduct a clinical trial to evaluate impact of Ayurveda treatment regimen in countering the post menopausal symptoms and improve quality of life in such individuals.

Ayurvedic Rasayana therapy along with Panchakarma procedures alike Abhyanga (Massage), Swedana (fomentation) and Shirodhara may help in balancing the vitiated Vata Dosha and gives a feeling of well being. Acharya Charaka has clearly mentioned that in all Vata Vikaras, Snehana should be the first line of treatment. Beyond this, Abhyanga also helps to ease the stress and anxiety associated with menopause but also help to restore internal balance within both the mind and body. After Abhyanga, Swedana is administered. Shirodhara is a type of Parisheka among the Murdha Taila. The rationality behind using Tarpana or Snehana (Massage) in menopause is that it is the preferred treatment to control Vata, which plays the main role in creating pathology. Hence, to find out an effective solution of menopausal problems with least side effects, this Study has been planned with following aims and objectives.

 
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