Premenstrual
syndrome is a common cyclic and recurrent disorder in female reproductive
population. It is characterized by somatic and psychological symptoms that
consistently occur during luteal phase of the menstrual cycle1. PMS
is a disease where many of them are unable to differentiate it into a disease
and procure proper care.
Recent studies
on prevalence of PMS states that nearly 50 percent of study population
presented symptoms of premenstrual syndrome2.Most women of
reproductive age have varying physical discomfort and psychological
disturbances prior to menstruation. Symptoms are often mild, but can be severe
enough to substantially affect daily activities, which can affect the overall
health of
the female.
Treatment which
are mentioned in contemporary science like Antidepressants, Diuretics,
Anxiolytic drugs SSRI (Selective
serotonin Reuptake Inhibitors, SNRI (Selective Nor adrenaline Reuptake
Inhibitors), GnRH analogues, Oral
contraceptive pills,Danazol3,4,5. etc have definitely some or other
side effects in long term usage.
The luteal phase can be considered as Rutuvyateeta Kaala, in this period the Pitta is predominant6 and Pittadushti Lakshanas such as Alpanidrata
(insomnia) , Balahani (tiredness,
fatigue, restlessness), Indriyadourbalya
( mood swings, forgetfulness, confusion, tension, irritability, depression,
anxiety etc)7,8.will be seen and there is no menstrual disorder
without involvement of Vata . Therefore
in this condition Vatapittashamaka Chikista will be the line of choice.
There is no definite treatment has been explained for PMS.
Based on Chikitsasutra of Yonivyapad we need to come out with
management. Hence there is wide scope of research. The Draksha which is said to be Shreshta
Phala and Vatapittashamaka9,
therefore Draksha in the form of Rasakriya selected for present study in
the management of PMS
MATERIALS AND METHODS:
7.1) SOURCE OF DATA:
(a)Literary
Source – Classical
text books of Ayurveda, text books of contemporary sciences, published
articles from journals and authentic websites.
(b)Drug source - The Draksha will be procured from
local market and will be authenticated by
Department of Dravyaguna vijnana JSS Ayurveda Medical College Mysuru.
Method of preparation: The
preparation will be done in JSS Ayurveda pharmacy (GMP Certified)
1
part of Draksha soaked in 4 parts of
water overnight. Next morning Draksha
grinded, and
Swarasa is extracted
out of it. Then Swarasa is boiled
till it attains semisolid consistency18and stored in air tight
container.
(c)Sample
source - Subjects fulfilling the criteria for diagnosis and inclusion
visiting OPD and IPD of Dept of Prasooti Tantra and Streeroga, JSS Ayurveda Medical
College and Hospital, Mysuru, medical camps and other referrals will be taken
for the study.
7.2) METHOD OF COLLECTION OF DATA:
a. Study design: It is an open label single arm clinical study.
b. Sample size: 30 subjects fulfilling the inclusion criteria
of Premenstrual syndrome will be selected for the study irrespective of
religion, occupation and socio-economic status.
c. Selection criteria: The subjects who
fulfill the inclusion criteria and complying with the informed consent will be
selected.
D.DIAGNOSTIC CRITERIA: 19
Subjects will be diagnosed based
on Diagnostic criteria proposed by ACOG
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Any one of affective
symptoms and at least one of the following somatic
symptom must be reported 5 days before menses and relieved within 4 days of the
onset of menses without recurrence until at least 13th day of the
cycle.
Affective symptoms
Somatic symptoms
1.Depression
1.Breast tenderness
2.Angry
outbursts 2.Abdominal
bloating
3.Irritability 3.Headache
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4.Anxiety
4.Swelling of extremities
5.Confusion
6.Social withdrawl
E.INCLUSION CRITERIA:
Ø Subjects
between the age group of 20-40
Ø
Subjects fulfilling the diagnostic criteria
F.EXCLUSION CRITERIA:
Ø Subjects
with untreated depression or psychiatric disorder.
Ø
Pregnancy and Lactation
Ø Diagnosed
case of metabolic disorders such as thyroid disease, diabetes mellitus…
Ø Subjects
with pelvic pathology
Ø Subjects
under hormonal medications such as oral contraceptive pills.
G.ASSESSMENT CRITERIA:
Assessment will be done with most available measures COPE (Calendar Of
Premenstrual Experience)20.
Severity of PMS symptoms will be rated by the participants on the basis
of impact on their daily
gives ranging from mild to moderate to severe.
Mild – Symptoms defined were not limiting daily activity.
Moderate – If there is marked limitations with regard to daily
activities.
Severe – Participants were unable to carry
out the activities without discomfort.
PLAN OF TREATMENT
The subjects will
be given with Draksha Rasakriya 10gm
BD starting from 5th day of menstruation till the beginning of the
next menstrual cycle for 3 consecutive cycles. The signs and symptoms will be
observed before and after the treatment.
Intervention period: 3 Cycles
Follow up: 2
Cycles
Total study duration: 5 Cycles
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