Brief
introduction-
Perimenopause refers to the time before,
during and after permanent cessation of menstruation. The perimenopausal symptoms
involve hot flashes, night sweats, vaginal itching, dryness of vagina, mood
swings, decreased libido which are caused due to decrease in estrogen levels1.
Hormone replacement therapy is indicated in perimenopausal woman to overcome
the short term and long term consequences of oestrogen deficiency. Oestrogen
when given orally undergoes ‘first pass’ metabolic effect in the gut and liver.
Hence transdermal hormonal gels are desirable with high drug penetrating power.
And most of the women found oral administration is difficult and inconvenient
in fast going life, transdermal gel application is yielding much results. But
the estrogen gel is having much adverse effects when compared with Ashwagandhadi transdermal gel, which is
having no adverse effects. The Ashwagandhadi transdermal gel comprises
of 3 drugs- Ashwagandha, Shatavari and
Mandooka parni. The presence of flavonoids in these drugs
will help to improve oestrogen level. Mainly the withenin present in Ashwagandha, casticin- castilliferol
present in Mandooka parni, luteolin
in shatavari are proven to have
highest phytoestrogen in them2. Hence the study is being undertaken.
Objectives
–
1.
To study the effectiveness of Ashwagandhadi transdermal gel in
reliving perimenopausal symptoms
2.
To compare the trial group with control group
applied with estrogen gel in relieving perimenopausal symptoms
Methodology
–
Method
of preparation - Ashwagandha, Shatavari and Mandooka parni
will be taken in equal proportion and the extracts will be extracted out
separately using cold maceration technique. Then gel will be prepared by
standard method of gel preparation by using carbopol as base and ashwagandha arka, shatavari arka, Mandooka
parni arka as liquid media. To this base the extracts will be added and the
gel will be prepared. Permitted preservatives (API) will be added to increase
shelf life. Finally the Ashwagandadi transdermal
gel will be packed in sterile tubes.
Intervention
plan-
|
|
Trial group
|
Control group
|
|
Treatment modalities
|
Application over the dry and cleaned both arms in
the manner of outer arm from shoulder down
|
Application over the dry and cleaned both arms in
the manner of outer arm from shoulder down
|
|
Area of application
|
shoulder
|
shoulder
|
|
Formulation
|
Ashwagandhadi transdermal gel
|
Estrogen
gel
|
|
Time
|
8
weeks
|
8
weeks
|
|
Duration of application
|
Once
in a day
|
Once
in a day
|
1. Research design-
Open labeled double arm
comparative clinical study
2. Source
of data -
·
Literary data – literary data is collected
from Ayurvedic Classical text, International journals, relevant research
literatures, contemporary medical textbooks.
·
Clinical data- It is a clinical study where
subjects fulfilling the diagnostic and inclusion criteria will be selected from
out-patient department of PG studies in Prasuti tantra Evum stri roga of S.D.M.
college of Ayurveda and hospital, Hassan. Proforma will be prepared with all
points of history taking, physical signs.
3. Sampling method-
convenient sampling
4.
Sample size= N=20 subjects
5.
Diagnostic criteria – diagnosis will be made on the basis of
following symptoms of perimenopause
Major
criteria-
·
Hot flashes or night sweats,
·
Fatigue, headache , irritability
Minor
criteria-
·
With or without depression, vertigo,
nervousness, Paresthesia, sexual complaints, urinary tract infections, ,
palpitations, formication, arthralgia,
myalgia, insomnia
6. Inclusion criteria-
·
Age group – 40 to 55 years3
·
Fulfilling diagnostic criteria
7. Exclusion criteria-
·
Any pre-existing psychological disorder
·
K/C/O
uncontrolled diabetes mellitus, hypertension, thyroid dysfunction
8. Study duration – 2 months
9. Follow up study-
Once
in 15 days during treatment
After
a month after treatment
10.
Assessment criteria
The
patients will be assessed on the basis of improvement in the symptoms of perimenopause
using Kuppermann’s menopausal scale
Criteria
for assessment of overall effect -
Overall
effect of the therapy will be assessed in terms of,
|
S.N.
|
Remission
|
Relief
in chief complaints( in terms of percentage)
|
|
1
|
Complete
remission
|
100
|
|
2
|
Marked
remission
|
75-99
|
|
3
|
Moderate
remission
|
50-74
|
|
4
|
Mild remission
|
25-49
|
List of references –
1. D.C. Dutta, Textbook of
gynecology, editor - Konar H, 6th edition, 2013, jaypee brothers
medical publishers (P).Ltd, 6th
chapter, p-57
2. Powers, C.N.,
Setzer, W.N. A molecular docking study of phytochemical estrogen mimics from
dietary herbal supplements. In Silico Pharmacol. 3, 4
(2015). [ springer] [ crossRef] [ Google scholar]
3.
Ahuja
Maninder. Age of menopause and determinants of menopause age: a PAN India
survey b IMS. 2016. Doi: 10.4103/0976-7800.191012 [PubMed]
[Google scholar ]. |