From,

Dr.Km. Pratima

Preliminary M.S (Ayu) Scholar

Dept.of Post Graduate Studies in PrasutiTantra&StriRoga
S.D.M College of Ayurveda & Hospital
Hassan- 573201
To,

The Registrar

Rajiv Gandhi University of Health Sciences

Karanataka, Banglore

Through,

The Principal& Head of the department of

P.G Studies in PrasutiTantra&StriRoga

S.D.M College of Ayurveda & Hospital,Hassan

Respected Sir,

Subject: Submission of completed proforma for Registration of subject for

I hereby request you to kindly register the above mentioned subject against my name for the
submission of Dissertation to the Rajiv Gandhi University of Health Sciences, Karnataka,
Bangalore for partial fulfilment of M.S(Ayurveda).

Title of the Dissertation:

TO EVALUATE THE EFFECT OF ASHWGANDHADI COMPOUND ON

PERIMENOPAUSAL SYMPTOMES.

Here with I am enclosing completed Proforma of Synopsis for Registration of subject for
dissertation.

Thanking You

Place: Hassan yours faithfully

Date: (Km Pratima)

 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA,

BANGALORE

Annexure II

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE : Km Pratima

AND ADDRESS Ist YEAR PG SCHOLAR

DEPARTMENT OF PG STUDIES

PRASUTI TANTRA& STRIROGA

S.D.M.COLLEGE OF AYURVEDA&

HOSPITAL, HASSAN-573 201.

PERMANENT ADDRESS: D/O SURENDRA PRASAD

C 19/ 128 – 3-G-1 NANAK NAGAR

SIGRA VARANASI

UTTAR PARDESH

2. NAME OF THE INSTITUTION : SDM COLLEGE OF AYURVEDA &

HOSPITAL HASSAN 573201

3. COURSE OF STUDY & SUBJECT : M.S. (AYURVEDA),

PRASUTI TANTRA &STRI ROGA

4. DATE OF ADMISSION : 26 NOV 2010

TO THE COURSE

5. TITLE OF THE TOPIC : EVALUATION OF THE EFFECT OF ASHVGANDHADI

COMPOUND ON PERIMENOPAUSAL SYMPTOMS
6. BRIEF RESUME OF THE STUDY

6.1 NEED FOR THE STUDY:

Menopause is permanent cessation of menstruation at the end of reproductive life.
During this period there is gradual but progressive loss of ovarian follicular activity.
Perimenopause is a period around menopause (40 – 55years) 1 presenting with psychological
such as mood disturbance, insomnia, cognitive difficulty, anxiety, depression, memory loss,
irritability and somatic symptoms like hot flushes, sexual disturbance etc. It begins with
menstrual cycle irregularities prior to menopause and extends 1 yr. after permanent cessation
of menses

Prevalence of psychological & somatic symptoms is seen in 80% of women at

Perimenopausal period1. Many women in Perimenopausal period may have symptomatic
condition which alarms her and her family, though the some may be asymptomatic or have
very minimum symptoms which go unnoticed. It is physiological but has major consequences
for the well being& health of most of the women. Making her consequences of the same
owing degree of discomfort experienced it make necessary to introduce medical therapy for
its management.

In Ayurvedic literature very few references are available on this physiological event under the
heading of Artava Kshaya3a, where the age of Rajonivrutti 3b.4 is said to be around 50 years &
probably, no reference about symptoms during this period of life 1,5,6,7. These symptoms are
more nearer to VataVriddhi symptoms, therefre its treatment may be of Vata. Further this
period belongs to Parihani Kala leading to Vriddhavastha, therefore Rasayana can be
considered.

According to the classical reference on Asvgandha9(Withania somnifera) is Balya and

Brahmna & recent research works showed its analgesic, antibacterial, anti-stress,
immunomodulator, immunostimulative & tonic actions.10

Brahmi11((Bacopa monnieri) is Kapha Pittahara, Medhya Rasayana. According to the

research work it is potent nervine tonic and cardiotonic.12

Shatavari13(Aspergus recemosa) has been shown to have beneficial effects in Perimenopausal

symptoms. It is Vata Pitta hara, Rasayana, Vrishya and uterine tonic. It contains diasogenin
which is a precursor for the semi synthesis of progesterone. The unmodified steroid has
estrogenic activity and can reduce the level of serum cholesterol14.

On the basis of the foregoing a compound named as Ashvagandhadi compound has been
formulated. It comprises of mixture of fine powders of Ashvagandha, Brahmi and Shatavari
to evaluate its effect in the management of perimenopausal symptoms.

6.2 REVIEW OF LITERATURE:

 1. SushrutaAcharya mention’s Rajonivrutti3c age as 50 year.
2. SushrutaAcharya explains there is Shithilata of Shareera in Vruddha Avastha 3c &
women attains Rajonivrutti3c stage at around 50 year.
3. Vagbhatta also explains Rajonivrutti kala15 at around 50 years of age.
4. Charaka explains benefits of Rasayana16 as it prevents ageing, weakness & diseases.
5. Charaka explains Rasayana Prayojana as life promoter, maintains positive health,
preserves health, and preserves youth, and cures morbid sleep, drowsiness, physical
and mental fatigue, laziness, weakness. It helps in balancing Tridosha, produces
stability, cures slothness of muscles, stimulates enzymes responsible for digestion &
metabolism and brings about excellence in lusture, complexion and voice16a.
6. Ashvagandha is Balya ,Katu Tikta Kashya rasa , Snigdha Laghu Guna,Usna virya ,
Madhura vipaka, Vata Kapha hara,Rasayana,Shukral9.
7. Brahmi is Tikta ,Kashay rasa, Laghuguna,Sheetavirya, Madhuravipaka, Kapha Pitta
hara , Medhya , Rasayana11.
8. Shatavri is MadhuraTtikta rasa, Guru Snigdhaguna, Sheetavirya, Madhuravipaka,
Vata Pitta hara, Rasayana, Vrushy13.
9. In Perimenopause period of women there is regression of ovarian function.1
10. Vaginal ph1,5 changes from acidic to alkaline, Pelvic relaxations 1,5 seen due to loss of
muscle tone.

PERIMENOPAUSAL SYMPTOMS1,5,6,7,17::
The term Perimenopause or climacteric generally refers to the time period in the late
reproductive years, usually late 40 to early 50’s. Begins with menstrual cycle irregularities
and extends 1 yr. after permanent cessation of menses, the terminology of menopausal
transition. This transition typically develops over a span of 4 to 7 yrs., & average age of its
onset is 47 yr.

Transition: the average age is 47yrs

Incidence: 10.15%

Mean age: 51.5 yr.

SYMPTOMS:
1. Hot flushes
2. Night sweats
3. Sleep disturbance
4. Depression
5. Irritability
6. Vaginal dryness
7. Decrease libido
8. Painful intercourse.

Drugs selected:
 Ashvagandha (Witheniasominiferadunal):Balya Bramhaniya, Rasayana
 Brahmi (Bacopamonnieri): Kaphapittahara,Medhya,Rasayana
  Shatavari(Aspergusrecemosa): VataPittahara Rasayana , Vryshya

PREVIOUS RESAERCH WORK CONDUCTED:

1. Vandana(1998): effect of certain ayurvedic drug in perimenopausal symptoms.
2. Deepika Baranwal (2004): comparative study of parijata & nirgundi in menopausal
low backache.
3. U.K Agrawal (2002): study on the effect of shatavari in rajonivritti. 1. Raval(ms) Dc-
Rajonivrutti - Jamnagar, Gujrat Ayurveda University - 1973
4. Modi.A. A Comparative Pharmaco-clinical study on Rasayana Kalpavati and
Mamsaadi Vati on RajonivruttiAvastha – JanyaLakshna (Menopausal syndrome) -
Jamnagar, Gujrat Ayurveda University-2002
5. Sood Ajay -. A comparative study between Rasayanavati and Shankpushpivati I
clinical study On Rajonivrutti – Jamnagar Ayurveda, Gujrath University-2000
6. Patel Devangi P : The role of Nasya (with Medhya drug ) in
RajonivruttiJanyalakshanaw.s.r. to Menopausal Syndrome – Jamnagar, Gujrath
Ayurveda, University-- 2004
7. MudhalDhanashree – DoshajaPrakrutiAnusaraRaljo- PravruttivaRajonivruttikala –
EkAdhyayan. – Nagpur, Nagpur University - 2001
8. ChavanArunku. p – A clinical study of RajonivruttikalajaLakshna and its management
with Shatavari – Pune, Pune University- 2004
9. DevareKiran Kumar – to study the relationship between Vandhyattavikara, Shastra
karma and Rajonivrutti – Pune, Pune University-2003
10. Agrawal(Kv)s - Rajonivrutti kalian Samasya Mien EkAyurvadeeyaAushadi Yoga
kaPrayogicAdhyayana – Ravishankar University , Raipur 1988
11. Agarwane UK – Study on the effect of Shatavari in
Rajonivruttilakshana(Perimenopausal and Menopausal Symptoms )Kerala University
, Trivendrum2002
12. KaushalKamini – Pharmacological of Varadadi yoga w.s.r to Post Menopausal
Syndrome – Jaipur, Rajisthan University - 2002
13. DharShipra – Effect of Vachaadi Compound in Menopausal Syndrome – Banaras
Hindu University, Varnasi - 2000
14. Pateria M – A Clinical study of ManasikaBhavas in Menopausal Syndrome and its
treatment by MedhyaRasayana and Shirodhara – Jamnagar, Gujrath University 2002
15. Arora Jasvindre – A Clinical study on onset of Menopause (Rajonivrutti) in reference
to Deha Prakruti. Delhi, Delhi University – 2006
16. Kavitha M B - Effect of Pranayama on Arthavanivritti W.S.R. to Climatric features.
RGUHS BANGLORE- 2006

6.3 OBJECTIVE OF THE STUDY:

1. To evaluate the effect of Ashvgandhadi compound on perimenopusal symptoms
2. To evaluate the effect of placebo on perimenopusal symptoms
3. Comparison of the effects of Ashvgandhadi compound with placebo group to
ascertain its effect on perimenopusal symptoms.

7. MATERIAL AND METHODS:

7.1 SOURCE OF DATA:
Case of Perimenopausal symptoms will be selected from OPD & IPD of departments of P.G
studies in Prasuti Tantra & Stri Roga S.D.M college of Ayurveda & hospital Hassan.

7.2 METHODS OF COLLECTION OF DATA:

Patient will be examined in detail with help of research proforma as prepared for study.

Diagnostic criteria:
Diagnosis will be made on the basis of the following symptoms of Perimenopause
occurring in a woman with irregular menses just prior to menopause or one year after the
menopause (40 years to 55 years)

 Hot flushes
 Night sweat
 Sleep disturbance
 Irritability
 Decrease libido
 Vaginal dryness
 Painful intercourse

Inclusion criteria –
 Age group of 40-50 yrs
 Vaginal dryness
 Hot flushes
 Night sweat
 Sleep disturbance
 Irritability
 Decrease libido
 Painful intercourse

Exclusion criteria –
 Any pre-existing psychological disorder
 Diabetes mellitus
 Age > 55 yrs.
 Post-menopausal women
 Pt. who undergone hysterectomy

Groups of treatment: 40 patients of perimenopausal will be randomly categorized into 2

groups, each comprising 20 patients.

Ashvagandhadi Compound Group: The patients of this group will be given Ashvagandahdi
powder in the dose of 4 gm three times a day with hot water for 3 months.
Placebo Control Group: The patients of this group will be given suitable placebo in the
powder form in the dose of 4 gm three times a day with hot water for 3 months.

Diet: The routine diet will be allowed during the study.

Duration of treatment-
Duration of treatment will be 3 months in both the groups.

7.3 Assessment criteria –

The patient will be assessed on the basis of improvement in the symptoms of
perimenopause

 Hot flushes
 Night sweat
 Sleep disturbance
 Irritability
 Decrease libido
 Vaginal dryness
 Painful intercourse
 Changes in the hormonal level & Hb% before and after treatment.

Follow up study:
After completion of the treatment the patients will be asked to attend the OPD at interval of
15 days for one month to ascertain whether the relief provided is sustained.

7.4 Laboratory investigation-

 Blood investigation –Haemogram
 Urine routine & microscopic
 Hormone profile – before & after treatment FSH & Serum oestradiol
 USG – To exclude any organic pathology.

7.5 Has ethical clearance been obtained from your institution? YES

8. LIST OF REFRENCE:

1. Text book of Gynaecology including conception by D.C Duttha 5th edition ,reprint -2009;
new central book agency (p) Ltd pg no. 55 -57.

2 www.google.com (list of countries by life expectancy in wikipidia).

3. SusruthaSamhitha edited with Ayurveda TattvaSandeepika , hindi commentary by
KaviraajaAmbikaDuttaShastri, reprint 2007, Chuakhambha Sanskrit Sansthan, Varanasi-
Publication

a.Sutrasthana- 14/6

b.Shareera sthana-3/11

4 .Astanga Hrudaya of Srimad vagbhatta edited with Nirmala, hindi commentary by Dr

BhrahmmanandTripathy , Chukambha Sanskrit Sansthan-Publication, Varanasi

ShareeraSthana – 1/7

5. Shaw text book of Gynaecology,byHowkins& Bourne 11th edition ,Edited by

V.Padubidri&Shrish N Daftrary:B.I.Church hill living stone Pvt. Ltd . New Delhi Chapter 3
Physiology ,pg no. 53-57

6. Dewhurst text book of Obstetrics & Gynaecology for post graduates 5th edition, Edited by
Charles R. White field ; international edition ;Chapter 41 The Menopausal &Climactricpg no
609-638

7. Gynaecologyillustrated,by A D T . Govan/D.Mckayhart Robin. Callander, church hill

living stone Publications Chapter 19th. The menopause pg no 472 -483

8. www.himalayahealthcare.com

9.Dravyagunavigyana vol. 2 gyanendrapandey , Chukambha Orientalia Publication, Varanasi

10.Data base on medicinal plants use in Ayurveda -3.central council of research in Ayurveda
siddha, New Delhi

11.Dravyagunavigyana vol. 2 gyanendrapandey , Chukambha Orientalia Publication,

Varanasi.

12.www.google.com (en.wikipedia.org/wiki/Bacopa_monnieri )

13.Dravyagunavigyana vol. 3 gyanendrapandey , Chukambha Orientalia Publication,

Varanasi

14.www.google.com ( Diasogin in Wikipedia)

15.AstangaHrudaya of Srimadvagbhatta edited with Nirmala, hindi commentary by Dr

BhrahmmanandTripathy , Chukambha Sanskrit Sansthan-Publication, Varanasi
ShareeraSthana – 1/17

16.Charaka Samhitha with Ayurveda Deepika ,Commentary by ChakrapaniDutta , Edited by

Dr Ram Karan Sharma &VaidyaBhagvanDash, Chukambha Sanskrit Sansthan- Publication,
Varanasi Reprint 2009

a.Charaka – ChikitsaSthana -1/2/3b.

b.Charaka – ChikitsaSthana - 1/3/31

c.Charaka – ChikitsaSthana – 1/1/79

17.Wiliamsgynaecology , department of obstetrics & gynaecology ,university of

texassouthwestern medical centre at dallas, oarkland health nad hospital system,
dallastexas,chapter 21, page no. 468

18.Sharangdhara samhita madhyama khand 6/9

9. SIGNATURE OF CANDIDATE :

10. REMARKS OF GUIDE :

11. NAME AND DESIGNATION OF

11.1 GUIDE : DR.PRITHIVIRAJ PAURANIK

Dept.of PG Studies in PrasutiTantraand

StriRoga S.D.M.College of Ayurveda.

Hassan. (Karnataka)

11.2 SIGNATURE :

11.3 H.O.D : DR. GAYATHRI BHAT N.V.

Dept.of PG Studies in PrasutiTantra and

StriRoga S.D.M.College of Ayurveda.

Hassan. (Karnataka)

11.4 SIGNATURE :

11.5 REMARKS OF CHAIRMAN

& PRINCIPAL :

11.6 SIGNATURE :