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
|
|
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
|
|
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. |